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Background: The gold standard treatment for periprosthetic joint infections is the two-stage revision that includes the spacer placement before definitive reimplantation. The management of PJI affects patients' joint function and, subsequently, their mental health. Even though significant advances have been achieved, little to no attention has been paid to the psychological implications. So, based on standardized patient-reported outcome measures (PROMs), this study aimed to clarify the effect of spacer treatment of infected hip and knee arthroplasties on patients' mental health. Methods: We performed research on the literature on PJIs in the English language using the MEDLINE database with the search strings "spacer" OR "spacers" AND "hip" OR "knee" AND "SF-12" OR "SF-36" OR "EQ-5" OR "mental" OR "depression" OR "anxiety." The reference lists of selected articles were also hand-searched for any additional articles. Results: A total of 973 published papers were extracted, and 9 papers were finally included. A total of 384 patients who underwent spacer placement for PJI were identified. Of these 384 patients, 54% were female. The mean age ranged from 62 to 78.2 years. Of the11 papers identified for this review, 4 analyzed only hip spacers, including 119 patients; 4 only knee spacers, evaluating 153 patients; while a single study included 112 patients for both joints. Conclusions: Patients with the spacer are living in a state of mental upset, albeit better than the preoperative state. Clinical improvement with the review is not assured. The alteration of mental state turns out not to be transient for all the patients. [ABSTRACT FROM AUTHOR]

Introduction: Evaluation of post-nephrectomy social health in living kidney donors is essential. This systematic review examines their emotional need for social relatedness post-donation. Methods: Following the PRISMA guidelines, we systematically searched Scopus, CINAHL, and PsycINFO. Results: Among the screened records, 32 quantitative and 16 qualitative papers met the inclusion criteria. Quantitative research predominantly utilized questionnaires featuring generic items on social functioning. However, a minority delved into emotional and social dimensions, aligning with qualitative studies emphasizing the importance of social connection and perceived social support post-donation. Specifically, post-donation changes in connecting with others encompass a sense of belongingness, heightened autonomy, shifts in concern for the recipient's health, and continued care by shielding the recipient from personal health issues. Social acknowledgment and social support from both close and extended networks are reported as relevant for recovery after nephrectomy. Discussion: These findings underscore the necessity for targeted measures of emotional needs and social functioning to effectively assess post-donation adjustment. They also inform the identification of key health themes for kidney donor Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) questions. [ABSTRACT FROM AUTHOR]

Patient-centered care is recognized as a key element in recent healthcare management strategies. However, the integrated collection of patient feedback capturing the entire journey of patients with complex medical conditions remains understudied. Herein, we aimed to describe the development of an instrument prototype for the collection of PROMs and PREMs that would encompass a whole patient journey at a single time point. We further describe the process of its integration into a hospital's information system (HIS) and the results of a pilot feasibility study in adult patients with kidney and hematological diseases. We developed an instrument consisting of original PREM and generic EQ-5D-5L questionnaires. E-questionnaires were handled with REDCap software (version 12.5.14) and integrated into the HIS. Patients refusing to use e-questionnaires (48%) were offered paper administration and were older (64 vs. 50 years). The overall response rate for e-questionnaires was 57.1% with a median completion time of 2.0 and 3.7 min for PROM and PREM, respectively. Psychological and social services and primary care setting (diagnosis establishment and involvement in continuous care) were identified as most problematic. The majority of PREM dimensions encompassing different levels of care significantly correlated with PROM responses. Our data indicate the feasibility and potential relevance of the proposed approach, although wider-scale studies in diverse settings are needed. [ABSTRACT FROM AUTHOR]

Simple Summary: The Sarcoma Assessment Measure (SAM) is a special questionnaire for patients with sarcomas, a type of cancer. It was created with input from both patients and healthcare professionals and is meant to be used by professionals to better understand how sarcoma affects a patient's life. We tested the SAM on 762 patients who had different types of sarcomas and ranged in age from 13 to 82. We found that the SAM could be a useful tool for both researchers and healthcare professionals to assess how sarcoma symptoms impact a patient's life. However, more testing with a larger and more diverse group of patients is needed to be sure it is a good outcome measure in drug trials. The Sarcoma Assessment Measure (SAM) was developed as a sarcoma-specific patient-reported outcome measure to be used in clinical practice. We have reported in detail how SAM has been developed in collaboration with patients and healthcare professionals. The aim of this paper is to report the preliminary validation of SAM. The 22-item SAM was administered alongside a validated quality of life questionnaire and measure of activities of daily living. Linear modelling was used to build a measure, which had predictive validity in comparison to more established outcome measures. Of the 762 patients who participated in the study, 44.1% identified as male, and participant age ranged from 13 to 82 years. Clinically, participants presented with a range of soft tissue (82.2%) and bone (21.8%) sarcomas. Our preliminary analysis indicates that SAM accounts for 35% of the global quality of life scale and 18% of the Toronto Extremity Salvage Scale (TESS); so psychometrically, it overlaps with quality of life and activities of daily living, but also measures distinct concerns. This demonstrates that this measure picks up issues that are important to patients with sarcoma that are not reflected in other measures. We have established the preliminary validity of SAM and believe it has utility as a patient-reported outcome measure both as a research tool and for assessing the impact of symptoms and dysfunction related to sarcoma as part of clinical care. Further validation using a larger and more clinically diverse sample is now needed. [ABSTRACT FROM AUTHOR]

Background: The transition from hospital to community settings for most mental health service users is often hindered by challenges that affect community adjustment and continuity of care. The first few weeks and days after discharge from mental health inpatient units represent a critical phase for many service users. This paper aims to evaluate the changes in the resilience, personal recovery, and quality of life status of individuals with mental health challenges recently discharged from acute mental health care into the community. Methods: Data for this study were collected as part of a pragmatic stepped-wedge cluster-randomized, longitudinal approach in Alberta. A paired sample t-test and Chi-squared/Fisher test were deployed to assess changes from baseline to six weeks in the recovery assessment scale (RAS), brief resilience scale (BRS), and EuroQol-5d (EQ-5D), using an online questionnaire. Results: A total of 306 service users were recruited and 88 completed both baseline and six weeks, giving a response rate of 28.8%. There was no statistically significant change in the level of resilience, recovery and quality of life as measured with the brief resilience scale, recovery assessment scale and EQ-5D from baseline to six weeks (p > 0.05). Conclusions: The study showed that there was neither an improvement nor deterioration in resilience, recovery, or quality of life status of service users six weeks post-discharge from inpatient mental health care. The lack of further progress calls into question whether the support available in the community when patient's leave inpatient care is adequate to promote full recovery. The results justify investigations into the effectiveness of innovative and cost-effective programs such as peer and text-based supportive interventions for service users discharged from inpatient psychiatric care. [ABSTRACT FROM AUTHOR]

Functional Ankle Instability (FAI) is the subject of extensive research in sports and other environments. Given the importance of accurately measuring this latent construct, it is imperative to carry out a careful assessment of the available tools. In this context, the aim of this review was to take an in-depth look at the six most cited measurement tools to assess FAI, with a specific focus on patient-reported outcome measures related to ankle and foot. Four electronic databases (Web of Science, Scopus, Pubmed, and SportDiscus) were searched (up to November 2022) to identify the six most cited questionnaires for assessing FAI. Our analysis showed that the most cited questionnaires are the following: the Lower Extremity Functional Scale (LEFS), the Foot Function Index (FFI), the Foot and Ankle Ability Measure (FAAM), the Foot and Ankle Outcome Score (FAOS), the Olerud and Molander Ankle Score (OMAS), and the Cumberland Ankle Instability Tool (CAIT). Each questionnaire was thoroughly assessed and discussed in three sections: Development, Reliability, and Summaries. In addition, bibliometric data were calculated to analyze the relevance of each questionnaire. Despite variations in terms of validity and reliability, conceptualization, structure, and usefulness, the six questionnaires proved to be robust from a psychometric point of view, being widely supported in the literature. The bibliometric analyses suggested that the FAOS ranks first and the FFI ranks sixth in the weighted average of the impact factors of their original publications. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has necessitated changes in European healthcare systems, with a significant proportion of COVID-19 cases being managed on an outpatient basis in primary healthcare (PHC). To alleviate the burden on healthcare facilities, many European countries developed contact-tracing apps and symptom checkers to identify potential cases. As the pandemic evolved, the European Union introduced the Digital COVID-19 Certificate for travel, which relies on vaccination, recent recovery, or negative test results. However, the integration between these apps and PHC has not been thoroughly explored in Europe. Objective: To describe if governmental COVID-19 apps allowed COVID-19 patients to connect with PHC through their apps in Europe and to examine how the Digital COVID-19 Certificate was obtained. Methodology: Design and setting: Retrospective descriptive study in PHC in 30 European countries. An ad hoc, semi-structured questionnaire was developed to collect country-specific data on primary healthcare activity during the COVID-19 pandemic and the use of information technology tools to support medical care from 15 March 2020 to 31 August 2021. Key informants belong to the WONCA Europe network (World Organization of Family Doctors). The data were collected from relevant and reliable official sources, such as governmental websites and guidelines. Main outcome measures: Patient's first contact with health system, governmental COVID-19 app (name and function), Digital COVID-19 Certification, COVID-19 app connection with PHC. Results: Primary care was the first point of care for suspected COVID-19 patients in 28 countries, and 24 countries developed apps to complement classical medical care. The most frequently developed app was for tracing COVID-19 cases (24 countries), followed by the Digital COVID-19 Certificate app (17 countries). Bulgaria, Italy, Serbia, North Macedonia, and Romania had interoperability between PHC and COVID-19 apps, and Poland and Romania's apps considered social needs. Conclusions: COVID-19 apps were widely created during the first pandemic year. Contact tracing was the most frequent function found in the registered apps. Connection with PHC was scarcely developed. In future pandemics, connections between health system levels should be guaranteed to develop and implement effective strategies for managing diseases. [ABSTRACT FROM AUTHOR]

Background: Assessment of upper limb function is critical in the rehabilitation process of people with Parkinson's Disease (PD), and universally validated outcome measures are needed to allow comparisons across the practice. Moreover, the study of psychometric properties of the same tool on different clinical populations guarantees the possibility of reliably evaluating the same rehabilitation treatment in people with different clinical conditions. Aim of the study: The aim of this research was to evaluate the psychometric characteristics of the Italian adaptation of the Jebsen Taylor Hand Function Test (JTHFT) in individuals with PD. Methods: The reliability and validity of the test were assessed in accordance with international standards. Internal consistency was measured using Cronbach's alpha, and test–retest reliability was determined via the intraclass correlation coefficient (ICC). The construct validity and cross-cultural validity of the test were evaluated using Pearson's correlation coefficient with three assessment tools on upper limb function, independence, and quality of life, with hand grip power measured by a dynamometer and an Italian pangram. Finally, responsiveness after a one month of rehabilitation treatment was measured using the Wilcoxon rank test. Results: Fifty-two Italian people with PD were recruited. Cronbach's alpha values ranged from 0.556 (non-dominant hand) to 0.668 (dominant hand); ICC values ranged from 0.754 to 0.988. Construct validity showed that several statistically significant correlations were detected. Wilcoxon's test showed that the assessment tool can detect a change in this population after treatment. Conclusions: The JTHFT is a reliable, valid, and respondent tool to evaluate the upper limb and hand functionalities in PD patients. It should be added to the toolkit for measuring upper limb performance in this population, adding value to clinical evaluation and ensuring comparable results for different clinical populations and different countries. [ABSTRACT FROM AUTHOR]

Quality of life (QoL) assessments are integral to cancer care, yet their effectiveness in providing essential information for supporting survivors varies. This study aimed to elucidate key indicators of QoL among colorectal cancer survivors from the perspective of healthcare professionals, and to evaluate existing QoL questionnaires in relation to these indicators. Two studies were conducted: a Delphi study to identify key QoL indicators and a scoping review of questionnaires suitable for colorectal cancer survivors. Fifty-four healthcare professionals participated in the Delphi study's first round, with 25 in the second. The study identified two primary QoL domains (physical and psychological) and 17 subdomains deemed most critical. Additionally, a review of 12 questionnaires revealed two instruments assessing the most important general domains. The findings underscored a misalignment between existing assessment tools and healthcare professionals' clinical priorities in working with colorectal cancer survivors. To enhance support for survivors' QoL, efforts are needed to develop instruments that better align with the demands of routine QoL assessment in clinical practice. [ABSTRACT FROM AUTHOR]

Simple Summary: Most cancer patients are older and have concomitant diseases because the incidence of most cancer types increases with age. This leads to patients taking a variety of medications that can cause drug-related problems (DRPs). DRPs can cause harm, including increased illness, avoidable hospital stays, and even death. Common DRPs are drug–drug interactions, not taking medication as prescribed, and adverse drug reactions. In our study, we aimed to assess these medication risks in hospitalized cancer patients and to identify factors that influence their health-related quality of life (HRQOL) as a patient-relevant outcome. The results of the pharmacist-led medication reviews show that DRPs are common in hospitalized cancer patients. Therefore, patient questionnaires about therapy-related symptoms could improve the detection of DRPs. While drug-related factors had no effect on HRQOL during the hospital stay, our analysis revealed other influencing factors, such as relapse status of the cancer disease and length of hospital stay. Background: We aimed to assess medication risks and determine factors influencing the health-related quality of life (HRQOL) in cancer inpatients. Methods: A retrospective analysis was conducted to identify drug-related problems (DRPs) based on medication reviews, including patient-reported outcomes (PROs). Multiple linear regression analyses were performed to identify sociodemographic, disease-related, and drug therapy-related factors influencing changes from hospital admission to discharge in the scales of the EORTC QLQ-C30 questionnaire. Results: A total of 162 inpatients with various hematological and solid cancer diseases was analyzed. Patients received a mean of 11.6 drugs and 92.6% of patients exhibited polymedication resulting in a mean of 4.0 DRPs per patient. Based on PRO data, 21.5% of DRPs were identified. Multiple linear regression models described the variance of the changes in global HRQOL and physical function in a weak-to-moderate way. While drug therapy-related factors had no influence, relapse status and duration of hospital stay were identified as significant covariates for global HRQOL and physical function, respectively. Conclusion: This analysis describes underlying DRPs in a German cancer inpatient population. PROs provided valuable information for performing medication reviews. The multiple linear regression models for global HRQOL and physical function provided explanations for changes during hospital stay. [ABSTRACT FROM AUTHOR]

Background: Patients with edentulism often have an impaired functional, phonetic, and esthetic status, resulting in poor quality of life; hence, the mandibular overdenture has been considered the standard implant treatment for such patients. Therefore, this study aimed to assess the effectiveness of mandibular overdentures retained using mini-implants on patient-reported satisfaction and their long-term survival. Methods: We searched patients' medical records for eligible subjects, screening and inviting patients who received a mandibular overdenture anchored on mini-implants over ten years ago. We used a numerical rating scale from 0 (the worst) to 10 (the best) to assess four aspects: comfort, retention, chewing ability, and speaking ability before and after having mini-implants. We carried out Kaplan–Meier analysis to assess their survival. Results: Forty-eight elderly patients who were medically compromised and had a mandibular overdenture anchored on four permucosal mini-implants were included. All patient-reported satisfaction (comfort, retention, chewing ability, and speaking ability) was significantly improved after supporting mandibular overdentures with mini-implants (p-values < 0.05), with retention and chewing ability being the most substantially improved. The 10- and 15-year mini-implant survival rates were both 97.9%. Conclusions: Mandibular overdentures with mini-implants can be considered a valid and practical alternative to conventional implant-supported overdentures in patients with atrophic ridges, medically compromised, and the elderly. [ABSTRACT FROM AUTHOR]

Children from vulnerable backgrounds often have insecure attachment or disorganized attachment, which are related to psychological troubles, and such children need interventions to help them heal. The attachment system reorganizes in middle childhood, and other important adults play a considerable role in children's lives. Thus, it is essential to weigh the impact of psychosocial interventions, while the main focus of the intervention is the staff member's direct work with the child through a trusting relationship. The primary purpose of this study is to investigate whether children's attachment security and mental health outcomes change after participating in a trauma-informed, attachment-based, Trust-Based Relational Intervention (TBRI) provided in a daycare center. It was a case-series study involving twelve children aged 8–11 years. The child attachment interview (CAI), CBCL/6-18, TRF/6-18, and clinical interviews for parents and children were used, measuring the change between the TBRI implementation in the daycare center and after one year. For ten participants, we noticed an improvement in mental health; for seven participants, security scales improved; for two participants, their disorganized attachment changed into insecure–dismissing. We have preliminary evidence that vulnerable children may benefit in terms of attachment security and mental health from the trusting relationship that staff build using the TBRI. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QOL) is frequently utilized in clinical medicine and research to assess a patient's health status and treatment effectiveness. Objectives: This study investigates the impact of vocational training on the QOL of visually impaired individuals. Methods: We employed the brief Taiwan version of the World Health Organization QOL Questionnaire (WHOQOL-BREFTW) to assess four domains: physical, psychological, social, and environmental, using a nonequivalent pretest–posttest control group design. The experimental group participated in 6 months of vocational training, including life and career reconstruction. After completing the vocational training, the average QOL score for the experimental group was 3.34 ± 0.18, while the control group had a score of 3.10 ± 0.85. The generalized estimating equation (GEE) results revealed a notable improvement of 10.81 (1.10) in the posttest overall QOL scores compared to the pretest scores in the control group. Conclusion: Vocational training significantly improves the overall QOL for visually impaired individuals. It is noteworthy that the psychological, social relationship, and physical health domains of WHOQOL-BREF TW exhibited the most significant improvements. This emphasizes the following: 1. professional knowledge and technical learning can enhance the abilities of the visually impaired. 2. The improvement in QOL occurs primarily at physical, psychological, and social levels. These levels involve maintaining physical health, reducing dependence on medical care, and enhancing self-care abilities for life reconstruction. 3. Integrating electronics with directional action can help to mitigate the risks associated with outdoor activities. [ABSTRACT FROM AUTHOR]

Background: ERAS® (Enhanced Recovery after Surgery) is an evidence-based multidisciplinary approach focusing on optimizing outcomes after surgery through structured clinical pathways. This study aimed to assess patient-reported outcome and experience measures (PROM/PREM), which are not routinely assessed after liver surgery within an ERAS® protocol. Methods: Routine outcome parameters were extracted from clinical documentation. Using qualitative content analysis, PROM and PREM were retrospectively identified in 13 case records. In a prospective survey of 10 participants, PROM was assessed at three timepoints using the EQ-5D-5L questionnaire. PREM were collected at discharge. Results: The following PROM categories occurred in the retrospective content analysis: appetite (84.6%), pain/discomfort (76.9%), mobility (69.2%), wound condition (69.2%), and weight (61.5%). The categories of continuity of care (92.0%) and information, communication, education (69.0%) emerged as PREM. Descriptive changes in health state were shown for all EQ-5D-5L dimensions and timepoints. At discharge, mobility, selfcare, usual activities, and pain/discomfort tended to be worse, whereas anxiety/depression decreased gradually from preoperatively to the 4 week follow-up. There was high satisfaction with interprofessional care services and experienced cooperation between professionals. Conclusions: PROM and PREM are helpful to incorporate patients' perspectives after liver surgery within an ERAS® pathway and should be collected routinely in clinical practice. [ABSTRACT FROM AUTHOR]

The theory of posttraumatic growth (PTG) proposes that from life difficulties positive changes can happen, such as deepened personal relationships and an awareness of new possibilities in life. PTG can occur naturally or can be facilitated. This study aimed to promote PTG through a school-based intervention of eight sessions of 45 min each with mindfulness and character strengths practices (the so-called "The exploration of happiness during the COVID-19 pandemic"). The study conducted assessments at baseline, post-intervention, and follow-up (i.e., one month after the intervention). The post-intervention results showed that the participants in the intervention group experienced an improvement in PTG, well-being, mindfulness, strengths use, and PTS symptoms compared to the children in the control group. Furthermore, these positive changes were sustained at follow-up. The findings of this study highlight that mindfulness-based strengths practices can increase positive outcomes (i.e., well-being, posttraumatic growth) and reduce negative psychological symptoms (PTS) among children. The implications for theory and practice are discussed, and detailed appendices for practitioners are provided. [ABSTRACT FROM AUTHOR]

Quality care in healthcare is a multifaceted concept that encompasses the execution of effective medical treatments and the patient's overall experience. It involves a multitude of factors, including effectiveness, safety, timeliness, equity, and patient centeredness, which are important in shaping the healthcare landscape. This cross-sectional study used the data from the Health Information National Trends Survey 6 (HINTS 6), which collects data on various aspects of health communication and information-seeking behaviors, to investigate the factors associated with quality care among White and Hispanic populations. All adults who participated in HINTS 6 and visited healthcare service at least once in the past 12 months were included in this study. Multivariable logistic regression was used to determine the association between quality care and delay or discriminated care with the adjustment of all other sociodemographic variables. We analyzed a total of 3611 participants. Poor social determinants of health (SDOHs) (OR 0.61, CI 0.43–0.88, p = 0.008), delayed needed medical care (OR 0.34, CI 0.26–0.43, p < 0.001), and discriminated care (OR 0.29, CI 0.15–0.54, p < 0.001) were all negatively associated with optimal quality care. Negative SDOHs could also be positively associated with delayed care and discriminated care. [ABSTRACT FROM AUTHOR]

The prevalence of intervertebral disc degeneration in the lumbar region resulting in low back pain is high. One of the treatment options is neurosurgery. Previous studies and systematic reviews demonstrate the need to identify factors that affect the health-related quality of life of patients undergoing surgery. This study aimed to analyze the sociodemographic and clinical factors that affect the quality of life of patients undergoing lumbar disc surgery. A group of 128 patients was assessed for eligibility and qualified by radiological examinations for lumbar disc surgery by a neurosurgeon in the outpatient clinic. Finally, 110 patients were studied and evaluated 24 h and 3 months after surgery. Health-related quality of life (36-Item Short Form Survey, SF-36), disability level (Oswestry Disability Index, ODI), and pain intensity (Visual Analogue Scale, VAS) were assessed. The mean pain intensity before surgery was 7.8 ± 2.3 pts and decreased significantly 24 h after surgery, with a mean score of 3.8 ± 2.4 pts (p = 0.0000). After three months, the increase in pain intensity was at 4.8 ± 2.4 pts, but the score was still significantly better than before surgery (p = 0.0024). The mean ODI score before surgery was 29.3 ± 8.4 pts (slight disability), and three months after surgery, there was an insignificant increase to a mean value of 31.5 ± 10.4 pts (p = 0.0834). There was a statistically significant increase in quality-of-life scores at three months after surgery in the following domains: physical functioning (8.7%; p = 0.0176), bodily pain (26.2%; p = 0.0000), vitality (5.8%; p = 0.0132) and mental health (6.2%; p = 0.0163), and a decrease in role limitations due to physical problems (3.8; p = 0.0013) and general health perception (6.7%; p = 0.0112). In conclusion, the surgical procedure plays an important role in improving the quality of life of patients operated on for intervertebral disc degeneration. It was effective in reducing the pain level, especially 24 h after surgery; however, surgery did not affect the disability level. [ABSTRACT FROM AUTHOR]

Simple Summary: This study collected clinical data on 278 pancreatic cancer patients who underwent pancreatic resection and compared the patient-reported outcomes in 128 patients following pancreatic resection. We observed a survival difference between malignancy, pre-malignancy, and benign disease groups. Mental component scores seem to improve over time, whereas no changes were observed in the physical component scores. The aims of this study were to assess patient-reported outcomes and the survival of patients following curative resection for pancreas cancer. Adult patients undergoing curative pancreatic resection between April 2014 and April 2019 across six major hospitals in Sydney were invited to complete the Short-Form 36 (SF-36v2) and the Functional Assessment Cancer Therapy—Hepatobiliary (FACT-Hep) questionnaires. Time from surgery was categorised into four different time points: 3–11, 12–23, 24–35, and 36–62 months. Survival analyses were performed using Kaplan–Meier and log-rank tests. A total of 278 patients underwent curative resection. Mean (SD) age was 65.0 (13.2), and 50.7% (n = 141) were males. Out of the 205 (74%) alive patients, 128 (62%) completed the study surveys. The physical component score and total FACT-Hep scores showed no significant changes over time. The mental component score improved from 3–11 months to 12–23 months (p = 0.009) and from 3–11 months to 36–62 months (p = 0.007). Survivorship showed a significant difference between malignancy, pre-malignancy, and benign disease groups, with 45.8 months (95%CI: 42.4–49.1), 40.3 months (95%CI: 36.4–44.2), and 41.3 months (95%CI: 37.9–44.9), respectively. For patients undergoing curative resection for pancreatic cancer, mental component scores improved over time, whereas overall survival outcomes seem to be influenced according to cancer pathology. [ABSTRACT FROM AUTHOR]

Introduction: The selection of an appropriate PROM is a crucial aspect in assessing outcomes. Questionnaires that have not been designed or validated for a paediatric population are routinely used. Using a questionnaire requires translation, cultural adaptation, and testing the psychometric properties of the translated questionnaire. There is no applicable questionnaire in our country for children with knee-specific conditions in sports orthopaedics. Therefore, this study aims to translate, culturally adapt, and assess the psychometric properties of the Paediatric IKDC (Pedi-IKDC) questionnaire within the Lithuanian paediatric population. Methods: The translation was conducted in accordance with international standards. Patients aged 11–17 years with various knee disorders participated in three surveys and completed the Pedi-IKDC, Lysholm, and PedsQL questionnaires. Interviews with patients following the translation process, in addition to floor and ceiling effects, were used to assess content validity. Cronbach alpha (α) statistics and the intraclass correlation coefficient (ICC) were applied to measure internal consistency and reproducibility, respectively. The standard error of measurement (SEM) and smallest detectable change (SDC) were calculated to assess reliability. Pearson correlations were calculated between Pedi-IKDC and Lysholm PedsQL scores to determine criteria validity. The effect size (ES) and standardised response mean (SRM) were calculated to assess the responsiveness to change. Results: Cronbach's alpha (α) was 0.91 for the total score, 0.75 for symptoms, and 0.92 for the sport/function component. The ICC for overall scores was 0.98, with each question ranging from 0.87 to 0.98. The SEM was 2.97, and the SDC was 8.23. Lysholm and PedsQL physical functioning domain scores had moderate correlations (0.8 > r > 0.5), and the overall PedsQL score had a weak correlation (0.5 > r > 0.2) to the Pedi-IKDC score. The floor and ceiling effects were 3.3% and 1.6%, respectively. The SRM was 1.72 and the ES was 1.98. Conclusions: The Lithuanian Pedi-IKDC version is an appropriate evaluation instrument for assessing outcomes in children with knee disorders. All of the psychometric features produced acceptable results. [ABSTRACT FROM AUTHOR]

Chronic low back pain (CLBP) is common in primary care, causing disability and economic burden globally. We aimed to compare socio-demographic, health, lifestyle, and psychological factors in people with and without CLBP and correlate them with clinical outcomes in people with CLBP. A total of 253 volunteers with and 116 without CLBP provided sociodemographic information, daily habits, medical history, subjective sleep complaints (Penn State Sleep Questionnaire), low back pain intensity, and disability (Quebec Back Pain Disability Scale), as well as the Zung Self-Rating Scale for self-assessment of depression and Self-Rating Anxiety Scale. CLBP diagnosis was linked with female gender and older age, as well as a higher level of sleep complaints such as sleepiness, OSA and insomnia symptoms, and a higher prevalence of moderate to severe depressive symptoms. The combination of moderate to severe depressive symptoms with obstructive sleep apnea or insomnia symptoms was the most important predictive factor for functional disability in CBLP patients (OR 13.686, 95% CI 4.581–40.885; p < 0.001). In conclusion, depressive symptoms and subjective sleep complaints appear to relate to greater CLBP intensity and/or CLBP-related disability in people with CLBP. A holistic approach is crucial for treating chronic CLBP patients, including psychological and sleep issue assessment and management, to improve their quality of life. [ABSTRACT FROM AUTHOR]

Introduction: Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease. The first PREM (patient-reported outcome measure)-type questionnaire that has been dedicated to assess the experience of care in COPD is the PREM-C9. Aim: The aim of this study was to create a Polish version of the PREM-C9 and determine its psychometric characteristics. Methods: The validation procedure involved forward and back translation. We included 42 patients with COPD. The psychometric properties were assessed using Cronbach's alpha, Bartlett's test, the Kaiser–Meyer–Olkin test, and Spearman's correlation coefficient. The validity of the questionnaire was assessed using a principal component analysis for the extracted principal components. The validity of the factor analysis was demonstrated using Bartlett's sphericity test and the Kaiser–Meyer–Olkin (KMO) test. A factor analysis was performed using the Oblimin and Varimax rotation. The reliability of the questionnaire was assessed using Cronbach's alpha. Results: The Polish version of the analyzed questionnaire met all the validation criteria: face, translation, psychometric, functional, and reconstruction equivalence. Spearman's correlation results between the Polish PREM-C9 and CAT were as follows: rho = 0.44, p = 0.003539; HADS-Anxiety: rho = 0.370864, p = 0.015612; and HADS-Depression: rho = 0.387405, p = 0.011253. Conclusions: The developed Polish PREM-C9 questionnaire is a reliable and valid tool that assesses Polish COPD patients' experiences of their disease and the care they receive. [ABSTRACT FROM AUTHOR]

Simple Summary: In the USA and Europe, questionnaires that allow patients to directly report chemotherapy side effects can improve their quality of life and clinical outcomes. No similar tools exist for Africa, so we aimed to design and validate a paper-based tool for use in oncology clinics in South Africa: The Patient Reported Symptoms-South Africa (PRS-SA) survey. The PRS-SA included questions on overall feelings of distress and severity of 11 common chemotherapy side effects. By comparing responses to the PRS-SA to responses to other quality of life questionnaires and to patients' performance status, we found the PRS-SA to be valid and responsive for measuring all included symptoms. Compared to a standard instrument for measuring depression and anxiety, the PRS-SA's distress thermometer had 88% sensitivity and 55% specificity for identifying distress. The PRS-SA may be a useful tool for efficiently assessing distress and chemotherapy symptoms in South Africa's overburdened public oncology clinics. Patient-reported outcome measures (PROM) for monitoring treatment toxicity improve quality of life (QoL) and clinical outcomes. However, no such PROMs exist for sub-Saharan African cancer patients. We aimed to validate the Patient Reported Symptoms-South Africa (PRS-SA) survey, a novel PROM for measuring distress and chemotherapy-related symptoms in South African cancer patients. We enrolled patients at the oncology clinic at Charlotte Maxeke Hospital, Johannesburg. At three separate visits, participants simultaneously completed the PRS-SA survey and several previously validated questionnaires. We constructed a receiver operator characteristics curve for distress levels predicting a Hospital Anxiety and Depression Scale (HADS) score ≥15. We evaluated construct validity for symptom items by comparing severity to the EORTC Core Quality of Life Questionnaire (QLQ-C30) summary score (Pearson correlation tests) and ECOG performance status (Mann–Whitney U tests). We assessed symptom item responsiveness by comparing change in severity to change in QLQ-C30 summary score and comparing standardized mean scores with negative, no, or positive change on the Global Impression of Change (GIC) questionnaire (Jockheere–Terpstra trend test). Overall, 196 participants with solid tumors completed instruments. A distress score of 4 had 82% sensitivity and 55% specificity for clinical depression/anxiety. All symptom items showed construct validity by association with either QLQ-C30 score or performance status (highest p = 0.03). All but cough showed responsiveness to change in QLQ-C30 score (highest p = 0.045). In South African cancer patients, the PRS-SA's stress scale behaves similarly to the distress thermometer in other populations, and the symptom items demonstrated construct validity and responsiveness. Of note, 46% and 74% of participants who completed the PRS-SA in English or isiZulu, respectively, required assistance reading half or more of the instrument. [ABSTRACT FROM AUTHOR]

Maintaining a healthy caloric intake and expenditure balance is challenging. The preliminary study examined (a) the associations of Body Mass Index (BMI), body image, perceived stress, mental health, dietary habits, and exercise participation among 310 female college nursing students and (b) the differences in these factors among BMI subgroups. The cutoffs for underweight, normal weight, overweight, and obesity were <18.5 kg/m2, ≥18.5 but <23 kg/m2, ≥23 but <25 kg/m2, and ≥25 kg/m2, respectively. The survey used Multidimensional Body-Self Relations Questionnaire—Appearance Scale, Perceived Stress Scale, and Chinese Health Questionnaire (CHQ). Because of a non-normal distribution, non-parametric statistics were used. The study found that BMI correlated with body image. The lower the BMI, the higher the satisfactory score the participants rated. BMI was irrelated to diet, exercise, stress, and mental health. The participants were unlikely to eat under stress and negative moods. The underweight group (17.1%) had the highest satisfactory score on their appearance evaluation. There was no difference between the overweight (14.2%) and obese (11.0%) groups. Meanwhile, the median of perceived stress was 18 and the prevalence of mental disturbance was 45.2% based on the CHQ. Underweight, overweight, obesity, high perceived stress, and poor mental health among nursing students warrant attention. Nurse educators should strengthen their coping strategies and provide support. A longitudinal study may consider incorporating coping strategies into the study design. [ABSTRACT FROM AUTHOR]

(1) Aims: to evaluate the effect on gait performance and standing stability of ankle-foot orthoses (AFO) in pediatric patients with hereditary motor-sensory neuropathy (HMSN). (2) Methods: a retrospective case-series study including three adolescents (S1, S2, S3, mean age 14 years) with HMSN. The subjects were evaluated barefoot, with carbon AFO (Botter) and with solid AFO (SAFO) by means of: gait analysis, stabilometry and gait functional tests (10 Meter Walk Test, 2 Minute Walk Test). Finally, the CSD-OPUS questionnaire was administered to the assess satisfaction and impact of the orthoses on life quality. (3) Results: orthoses improved gait and stability performance. Botter allowed greater ankle movement than SAFO and provided greater push-off power. This, combined with the carbon elastic energy return, might explain better performances in the 2MWT, with a larger distance traveled compared to SAFO for both S1 (110 m vs. 72 m) and S2 (170 m vs. 155 m) and, compared to barefoot walking, also for S3 (211 m vs. 160 m), for which SAFO analysis was not available. Both orthoses improved performance at the stabilometric analysis. The CSD-OPUS questionnaire showed a significantly higher level of satisfaction with Botter for the subjects (S1, S2) who completed the comparison. (4) Conclusions: Both orthoses improved gait and standing, though Botter proved to be better tolerated and more effective in improving gait endurance. [ABSTRACT FROM AUTHOR]

Simple Summary: Based on previous work, we designed a new questionnaire that asks patients to report how they feel after undergoing plaque radiation treatment for a certain type of eye cancer. This study aimed to test that the questionnaire measured what it was intended to measure. The questionnaire was given to 439 patients from three clinics in Canada and the United States of America. The results indicated that the questionnaire measures three domains: symptoms and their impact on the patient, the patient's worry, and the patient's discomfort. The questionnaire is easy to use and reliable. The questionnaire can help doctors manage patient care after the treatment. The objective of this study was to evaluate the psychometric properties of a new patient-reported outcome instrument intended for use with patients who have undergone brachytherapy for uveal melanoma (PROM-UM). Classical test theory and item response theory were used to evaluate the performance of individual items and domains. A convenience sample of 439 participants who had undergone brachytherapy for uveal melanoma from one of three North American ocular oncology treatment centers were included in this cross-sectional study. Exploratory factor analysis identified three domains which were labelled "Symptom Impairment", "Worry", and "Discomfort". The acceptability of the instrument was supported by little missing data (range = 0.00–1.14%) and low maximum endorsement (range = 0.00–1.82%). Item-total (range = 0.68–0.85) and inter-item (range = 0.74–0.80) correlations indicated acceptable reliability. Discrimination and difficulty were assessed using item response theory. Items in all three domains indicated moderate to very high discrimination (range = 1.00–4.10). Two items in the Symptom Impairment domain were too difficult to measure. Response ranges in the other two domains demonstrated acceptable difficulty. These results from the study indicate that this new patient-reported outcome instrument can be used with patients treated with brachytherapy for uveal melanoma. Providers could use this instrument to help inform post-treatment management. [ABSTRACT FROM AUTHOR]

Background: A large percentage of people with type 1 diabetes experience stigma, which may directly affect diabetes management. Moreover, it may adversely influence the acceptance of the disease and, thus, the treatment process, including compliance with medical and dietary recommendations. Therefore, it is important to seek adequate forms of counteracting the phenomenon of stigmatization. Thus, the aim of the study was to determine the factors influencing the level of perceived stigma by T1D patients, with particular emphasis on sociodemographic factors (including sex, place of residence, and education) and clinical factors related to the course of the disease. Methods: An observational cross-sectional online questionnaire was conducted in a group of 339 people with T1D. The link to the questionnaire was shared via social media. The DSAS-1 questionnaire translated into Polish was used as the research tool. Results: A moderate level of stigmatization was found (49.78 ± 14.54 points). It was significantly lower in people living in small towns compared to rural residents (ß = −0.121, p = 0.038), lower in people in relationships compared to those who are single (ß = −0.175, p = 0.001), in people diagnosed with T1D at an older age (ß = −0.107, p = 0.048), and in those who rated their financial situation as very good vs. bad (ß = −0.314, p < 0.001). It was also found that the level of stigma significantly decreased with age (ß = −0.181, p = 0.001). In addition, a significantly higher stigma perception was uncovered in the group of people with HbA1C > 7% than in the group ≤ 7% (ß = 0.118, p = 0.030). Conclusions: Due to the occurrence of stigma among people with T1D, which can directly affect the management of diabetes, effective and comprehensive efforts should be made to provide support to people with diabetes. It is also necessary to raise awareness among the general public and disseminate knowledge about diabetes, which can reduce stigmatization as a result. Anti-stigma messages should be included in the prevention programs about the potential side effects and risks associated with mistreating people with T1D. [ABSTRACT FROM AUTHOR]

For some students, school success is not a simple matter. A growing, innovative approach that supports students' functioning at school is programs in which animals are involved in education. The involvement of animals, especially dogs, in education is known as animal-assisted education (AAE). A literature review of AAE indicated a positive influence of AAE programs on the quality of learning and social emotional development in children. This study explored whether AAE positively impacts the social and emotional outcomes of elementary school students aged between 8 and 13 years through mixed methods. The methods used were a survey and an observational study. The survey section of the study showed that students participating in the program with the dogs rated themselves, after the intervention period, significantly higher in terms of self-confidence and had a more positive score for relationships with other students after the intervention. As rated by their teachers, after the intervention period, students scored significantly higher in relation to work attitude, pleasant behavior, emotional stability, and social behavior. In the observational study, we analyzed the video material of students who participated in an AAE program with dogs. We concluded that all verbal and non-verbal behaviors of the students increased, except eye contact. The current study indicates future directions for theoretical underpinnings, improved understanding, and the empirical measurement of the underlying variables and mechanisms. [ABSTRACT FROM AUTHOR]

Background: The population of individuals affected by breast cancer is growing, and with advances in cancer treatment implemented into usual care, there is an urgent need to improve the recognition, monitoring and treatment of therapy-induced adverse effects. This study aims to explore the use of an in-app electronic questionnaire to assess and monitor chemotherapy-related symptoms in early breast cancer patients treated with perioperative chemotherapy. Method: Between December 2019 and June 2021, 72 female study participants used the mobile app Centrum Chorób Piersi UCK and completed an in-app questionnaire about the 14 most common chemotherapy-related symptoms. Replies including symptoms with a critical value triggered automatic email alerts to the nursing team. Results: Acceptance of the study was higher among younger women and patients originating from rural areas, while possible digital exclusion among patients >60 years was observed during the enrolment process. A total of 55 participants completed the electronic questionnaire at least once and generated 553 responses with 1808 specific problems reported. Fatigue (n = 428) was the most common problem, and fever (n = 5) the least reported problem. A total of 21 participants triggered alerts with responses containing symptoms with critical value assessment (n = 89). Significant negative correlation was observed between the number of responses and time from the first chemotherapy administration; however, the number of responses was not determined by any sociodemographic or medical factors. Significant positive correlations were identified between the number of communicated problems and participants' age. The usage of our electronic symptom assessment questionnaire decreased substantially after the period of active encouragement during the study enrolment. Conclusions: Not all societies are ready for innovative eHealth solutions. Patients' age should be carefully considered when app-based interventions are introduced to usual cancer care. Additional support is suggested for older patients to improve their awareness and participation in eHealth interventions. More research involving older participants is needed to explore and address their particular needs and perspectives on eHealth solutions. [ABSTRACT FROM AUTHOR]

To evaluate the adoption of an integrated eHealth platform for televisit/monitoring/consultation during the COVID-19 pandemic. Methods: During the lockdown imposed by the Italian government during the COVID19 pandemic spread, a dedicated multi-professional working group was set up in the Radiation Oncology Department with the primary aim of reducing patients' exposure to COVID-19 by adopting de-centralized/remote consultation methodologies. Each patient's clinical history was screened before the visit to assess if a traditional clinical visit would be recommended or if a remote evaluation was to be preferred. Real world data (RWD) in the form of patient-reported outcomes (PROMs) and patient reported experiences (PREMs) were collected from patients who underwent televisit/teleconsultation through the eHealth platform. Results: During the lockdown period (from 8 March to 4 May 2020) a total of 1956 visits were managed. A total of 983 (50.26%) of these visits were performed via email (to apply for and to upload of documents) and phone call management; 31 visits (1.58%) were performed using the eHealth system. Substantially, all patients found the eHealth platform useful and user-friendly, consistently indicating that this type of service would also be useful after the pandemic. Conclusions: The rapid implementation of an eHealth system was feasible and well-accepted by the patients during the pandemic. However, we believe that further evidence is to be generated to further support large-scale adoption. [ABSTRACT FROM AUTHOR]

Simple Summary: Myelodysplastic syndromes are a heterogenous group of bone-marrow cancers that prelude a possible evolution to acute myeloid leukemia. Most treatments aim at reinstalling bone marrow function and delay evolution to acute leukemia. The disease has a negative impact on health-related quality of life and amelioration is an independent treatment goal. In order to capture the impact of current treatments outside clinical trials we aimed to monitor quality of life during the course of treatment. Another key element in our study was to prospectively assess disease perception and the impact on quality of life. Not reaching our inclusion goal, we cannot make any conclusions or assumptions on our first objective. We can, however, demonstrate a clear significant relation between disease perception and health related quality of life in this patient population that may lead to a positive impact for future patients. Patients with myelodysplastic syndromes suffer from an impaired quality of life that is only partially explained by physical symptoms. In an observational study, we aimed to investigate the impact of current MDS treatments and the influence of disease perception on quality of life. Serial measurement of health-related quality of life was performed by 'the QUALMS', a validated MDS-specific patient reported outcome tool. Disease perception was evaluated by means of the Brief Illness Perception Questionnaire (B-IPQ). We prospectively collected data on 75 patients that started on a new treatment and could not demonstrate a significant change in QUALMS score or B-IPQ score during treatment. Six out of eight items evaluated in the B-IPQ correlated significantly with QUALMS score. In this small sample, no significant difference in QUALMS score was found between lower vs. higher risk MDS patients or other studied variables, e.g., targeted hemoglobin showed no correlation with QUALMS score. In daily practice attention must be paid to initial formation of disease perception as it correlates independently with health-related quality of life and does not change during treatment (clinicaltrials.gov identifier: NCT04053933). [ABSTRACT FROM AUTHOR]

Background: It is believed that ultrasound-guided imaging of activation/contraction of the deep abdominal muscles (such as transervsus abdominis) is useful for assisting deep muscle re-education, which is often dysfunctional in non-specific low back pain (NSLBP). Thus, this pilot study aimed to evaluate the use of real-time ultrasound (US) as a feedback device for transverse abdominis (TrA) activation/contraction during an exercise program in chronic NSLBP patients. Methods: Twenty-three chronic NSLBP patients were recruited and randomly assigned to a US-guided (n = 12, 8 women, 47.6 ± 2.55 years) or control group (n = 11, 9 women, 46.9 ± 4.29 years). The same motor control-based exercise program was applied to both groups. All patients received physiotherapy twice per week for seven weeks. Outcome measures, tested at baseline and post-intervention, included Numeric Pain Rating Scale, TrA activation level (measured through a pressure biofeedback unit-based developed protocol), seven established motor control tests, Roland-Morris Disability Questionnaire and Hospital Anxiety and Depression Scale. Results: For each group, all outcome variables yielded statistical differences post-intervention (p < 0.05), indicating significant improvements. However, there were no significant group x time interactions for any of the outcomes (p > 0.05), thus, indicating no superiority of the US-guided group over the control. Conclusions: The addition of US as a visual feedback device for TrA re-education during a motor control exercise program was not proven superior to traditional physiotherapy. [ABSTRACT FROM AUTHOR]

Simple Summary: Despite the fact that self-rated health is an established and independent predictor for future health outcomes, patient-reported outcomes (PROs) are rarely utilized in clinical decisions. Such an approach can be a disadvantage for patients who might benefit from the early detection of subtle signs of deterioration in the quality of life. The present study explored the determinants of various quality-of-life trajectories during the first year after breast cancer treatment. We recognized three distinct trajectories of global quality of life: 'high', 'U-shape' and 'low'. Our results indicate that taking PROs into account allows for a more accurate prediction of a given quality-of-life trajectory than considering only medical and sociodemographic characteristics. Concentrating on the patient's perspective in the clinical interview is recommended, especially for patients with permanent or fluctuating lower quality of life. Despite the current shift in medicine towards patient-centered care, clinicians rarely utilize patient-reported outcomes (PROs) in everyday practice. We examined the predictors of quality- of-life (QoL) trajectories in breast cancer (BC) patients during the first year after primary treatment. A total of 185 BC patients referred for postoperative radiotherapy (RT) filled in the EORTC QLQ-C30 Questionnaire assessing global QoL, functioning and cancer-related symptoms before starting RT; directly after RT; and 3, 6 and 12 months after RT. We used decision tree analyses to examine which baseline factors best allowed for predicting the one-year trajectory of the global QoL after BC treatment. We tested two models: 'basic', including medical and sociodemographic characteristics, and 'enriched', additionally including PROs. We recognized three distinct trajectories of global QoL: 'high', 'U-shape' and 'low'. Of the two compared models, the 'enriched' model allowed for a more accurate prediction of a given QoL trajectory, with all indicators of model validation being better. In this model, baseline global QoL and functioning measures were the key discriminators of QoL trajectory. Taking PROs into account increases the accuracy of the prediction model. Collecting this information in the clinical interview is recommended, especially for patients with lower QoL. [ABSTRACT FROM AUTHOR]

Healthcare professionals, especially nurses, play a central role in supporting parents during their stay in neonatal intensive care units (NICUs). Fathers often have their own support needs; however, studies have shown that these needs are rarely met to the same degree as those of the mothers. We developed a "father-friendly NICU" with the aim of providing good-quality care to the entire family. To evaluate the impact of this concept, we adopted a quasi-experimental design; using the Nurse Parent Support Tool (NPST), we investigated the differences in the fathers' (n = 497) and mothers' (n = 562) perception of the nursing support received on admission and discharge between before and after the intervention. In the historical control and intervention groups, the fathers' median NPST scores at admission were 4.3 (range, 1.9–5.0) and 4.0 (range, 2.5–4.8), respectively (p < 0.0001); at discharge, these scores were 4.3 (range, 1.6–5.0) and 4.4 (range, 2.3–5.0), respectively (difference not significant). In the historical control and intervention groups, the mothers median NPST scores at admission were 4.5 (range, 1.9–5.0) and 4.1 (range, 1.0–4.8), respectively (p < 0.001); at discharge, these scores were 4.4 (range, 2.7–5.0) and 4.4 (range, 2.6–5), respectively (difference not significant). The parental perception of support did not increase after the intervention; however, the parents reported a high level of staff support both before and after the intervention. Further studies should focus on parental support needs during the different phases of hospitalization (i.e., admission, stabilization, and discharge). [ABSTRACT FROM AUTHOR]

Simple Summary: The EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire is a globally used and multiply validated tool to assess health-related quality of life (HRQoL), but data on its use for patients with myeloid neoplasias is scarce. The aim of this prospective cohort study was to alleviate this knowledge gap. Our data show in a homogenous population of azacitidine-treated patients for the first time that (1) myeloid patients have significantly worse HRQoL than a population norm (i.e., a representative sample of the German general adult population) from a similar geographic region, matched by age, sex and number of comorbidities; (2) The EQ-5D-5L questionnaire response provides added prognostic value to the International Prognostic Scoring System (IPSS) and the revised IPSS (R-IPSS), which are longstanding gold standards of prognostication in these diseases; (3) the multivariate-adjusted significant predictive value of the EQ-5D-5L response parameters on patient outcomes including response to azacitidine, time to next treatment and overall survival; (4) longitudinal assessment of the EQ-5D-5L response/clinical parameter pairs revealed significant additional, independent associations. In this prospective study (NCT01595295), 272 patients treated with azacitidine completed 1456 EuroQol 5-Dimension (EQ-5D) questionnaires. Linear mixed-effect modelling was used to incorporate longitudinal data. When compared with a matched reference population, myeloid patients reported more pronounced restrictions in usual activities (+28%, p < 0.0001), anxiety/depression (+21%, p < 0.0001), selfcare (+18%, p < 0.0001) and mobility (+15%, p < 0.0001), as well as lower mean EQ-5D-5L indices (0.81 vs. 0.88, p < 0.0001), and lower self-rated health on the EuroQol Visual Analogue Scale (EQ-VAS) (64 vs. 72%, p < 0.0001). After multivariate-adjustment, (i) the EQ-5D-5L index assessed at azacitidine start the predicted time with clinical benefit (TCB) (9.6 vs. 6.6 months; p = 0.0258; HR = 1.43), time to next treatment (TTNT) (12.8 vs. 9.8 months; p = 0.0332; HR = 1.42) and overall survival (OS) (17.9 vs. 12.9 months; p = 0.0143; HR = 1.52); (ii) Level Sum Score (LSS) predicted azacitidine response (p = 0.0160; OR = 0.451) and the EQ-5D-5L index showed a trend (p = 0.0627; OR = 0.522); (iii) up to 1432 longitudinally assessed EQ-5D-5L response/clinical parameter pairs revealed significant associations of EQ-5D-5L response parameters with haemoglobin level, transfusion dependence and hematologic improvement. Significant increases of the likelihood ratios were observed after addition of LSS, EQ-VAS or EQ-5D-5L-index to the International Prognostic Scoring System (IPSS) or the revised IPSS (R-IPSS), indicating that they provide added value to these scores. [ABSTRACT FROM AUTHOR]

Robotic gait training has the potential to improve secondary health conditions for people with severe neurological impairment. The purpose of this study was to describe who is using the Trexo robotic gait trainer, how much training is achieved in the home and community, and what impacts are observed after the initial month of use. In this prospective observational single-cohort study, parent-reported questionnaires were collected pre- and post-training. Of the 70 participants, the median age was 7 years (range 2 to 24), 83% had CP, and 95% did not walk for mobility. Users trained 2–5 times/week. After the initial month, families reported a significant reduction in sleep disturbance (p = 0.0066). Changes in bowel function, positive affect, and physical activity were not statistically significant. These findings suggest that families with children who have significant mobility impairments can use a robotic gait trainer frequently in a community setting and that sleep significantly improves within the first month of use. This intervention holds promise as a novel strategy to impact multi-modal impairments for this population. Future work should include an experimental study design over a longer training period to begin to understand the relationship between training volume and its full potential. [ABSTRACT FROM AUTHOR]

Simple Summary: Therapeutic options for advanced soft tissue sarcoma (STS) are limited. Health-related quality of life (HRQoL), along with traditional outcome parameters such as tumor control and toxicity, is one of the most important endpoints for palliative STS treatment. The PazoQoL prospective, randomized, controlled, multicenter study (EudraCT number 2017-003382-10, ClinicalTrials.gov Identifier NCT0373575) was designed to assess the impact of treatment on HRQoL and patient-reported outcomes. Although the study had to be terminated early due to the pandemic, some valuable results were collected on the continuous recording of symptoms over a 9-week period and on patient satisfaction with therapy. Our findings could be translated into clinical practice without much effort and outside of a trial. The PazoQoL prospective, randomized, controlled, multicenter study was designed to continuously assess global health related quality of life (HRQoL) during treatment with pazopanib or physician-preferred chemotherapy over a 9-week period. The questionnaires were completed by the patients at home with great reliability during this time period. Continuous electronic patient reported outcome (ePRO) enabled early detection of the onset of deterioration and timely initiation of countermeasures. The Cancer Therapy Satisfaction Questionnaire (CTSQ) showed high interindividual variability and decline over a 9-week period, whereas the Time Trade-off (TTO) proved to be an efficient method for assessing individual benefit from cancer therapy. In our cohort, the TTO clearly demonstrated that the prolongation of life and the side effect profile of continued therapy were not as satisfactory as expected by patients when starting a new therapy. Although the study had to be stopped early due to the pandemic, our findings could translate into clinical practice without much effort and outside of a trial. [ABSTRACT FROM AUTHOR]

Poor supervision, impaired exercise adherence, and low compliance with exercise regimens result in inconsistent effects regarding exercise interventions. A supervised-walk training regimen (9 km/week) may have a positive effect on functional recovery in female total knee arthroplasty (TKA). This study aimed to evaluate the effect of a supervised walking regimen on lower limb muscle strength, functional fitness, and patient-reported outcomes in female TKA. Twenty-eight female TKA were allocated into a control (CON) (n = 14) or walk training (WT) (n = 14) group. WT on treadmills was initiated 12 weeks after TKA. All patients were examined for lower muscle strength (including extension and flexion of hip and knee), physical function (including a 6-min walk test, 8-foot up-and-go test, and 30-s chair stand test), and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Knee flexor (WT: CON; 64.4 ± 4.1 nm/kg: 43.7±3.3 nm/kg; p = 0.001; effect size: 5.62) and extensor strengths (WT: CON; 73.1 ± 7.5 nm/kg: 48.2 ± 2.4 nm/kg; p = 0.001; effect size: 4.47) statistically increased in the WT group compared to the CON group. The 6-min walk test (from 341.3 ± 20.5 m to 405.5 ± 30.7 m; p = 0.001; effect size: 2.46) and 8-foot up-and-go test (from 9.5 ± 0.7 s to 8.3 ± 0.7 s; p = 0.002; effect size: 1.71) tests also showed significant improvements in the WT group in the follow-up compared to the baseline. An increase in quality of life score according to the KOOS questionnaire (WT: CON; 91.0 ± 2.8: 68.1 ± 5.8; p = 0.001; effect size: 5.02) was noted in the WT group compared to the CON group in the follow-up. WT facilitated improvements in knee muscle strength and functional outcomes in TKA patients. [ABSTRACT FROM AUTHOR]

Objectives: Evaluate diagnostic accuracy and feasibility of a mail-out home oximetry kit. Design: Patients were referred for both the tertiary/quaternary-centre hospital-delivered oximetry (HDO) and for the mail-out remotely-delivered oximetry (RDO). Quantitative and qualitative data were collected. The COVID-19 pandemic began during this study; therefore, necessary methodological adjustments were implemented. Setting: Patients were first evaluated in Swan Hill, Victoria. RDO kits were sent to home addresses. For the HDO, patients travelled to the Melbourne city area, received the kit, stayed overnight, and returned the kit the following morning. Participants: All consecutive paediatric patients (aged 2–18), diagnosed by a specialist in Swan Hill with obstructive sleep apnoea (OSA) on history/examination, and booked for tonsillectomy +/− adenoidectomy, were recruited. Main outcome measures: Diagnostic accuracy (i.e., comparison of RDO to HDO results) and test delivery time (i.e., days from consent signature to oximetry delivery) were recorded. Patient travel distances for HDO collection were calculated using home/delivery address postcodes and Google® Maps data. Qualitative data were collected with two digital follow-up surveys. Results: All 32 patients that had both the HDO and RDO had identical oximetry results. The HDO mean delivery time was 87.7 days, while the RDO mean delivery time was 23.6 days (p value: <0.001). Qualitatively, 3/28 preferred the HDO, while 25/28 preferred the RDO (n = 28). Conclusions: The remote option is as accurate as the hospital option, strongly preferred by patients, more rapidly completed, and also an ideal investigation delivery method during certain emergencies, such as the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

The StimQ questionnaire is used to assess the home environment of children. The questionnaire is comprised of four subscales, and it was completed by the main caregiver. The items were different considering the band ages of the children: infants (5–12 months), toddlers (12–36 months), and preschoolers (36–72 months). The aim of the study was to translate, transculturally adapt, and evaluate the psychometric characteristics of the Italian version of the StimQ. To achieve this goal, a sample of 142 children was recruited from different kindergartens. The mean age of the group was 30.63 (SD 19.56), and 112 of them were female. The main caregiver was the mother in 95% of the cases. The Cronbach's alfa was excellent, considering the total score (0.82 for infants, 0.85 for toddlers, and 0.86 for preschoolers). Intrarater reliability was performed by administering the questionnaire after 48 h and by two different researchers. Both analyses showed an excellent reliability for the total score and all the subscales. The intrarater reliability was 0.99 for the infant, 1 for the toddler and 0.99 for the preschooler age groups. The interrater reliability was 0.95 for the infant, 0.93 for the toddler, and 0.97 for the preschooler age groups. The StimQ is a reliable questionnaire that could be helpful for clinicians and researchers who work with children in Italy. [ABSTRACT FROM AUTHOR]

Objective: This study is a preliminary evaluation of how perceived barriers towards transition might impact patient attitudes towards their own readiness and ability to transition, self-efficacy towards their IBD, and the allocation of treatment responsibility. Methods: A sample of 81 young adults with IBD were seen for standard care in a Young Adult Clinic (YAC). Patients completed questionnaires on perceived transition barriers; perceived confidence, importance, motivation, and readiness towards transition and transfer; IBD self-efficacy; and allocation of treatment responsibility. Path model analyses were conducted. Results: Not knowing how and who to transfer to and not understanding insurance details were the most commonly endorsed perceived barriers to transition. A significant relationship was found between the attitude toward transition and allocation of treatment responsibility, but no meaningful indirect effects were found from perceived barriers to the allocation of treatment responsibility, using attitudes toward transition as an intervening variable. The relationship between perceived barriers and allocation of treatment responsibility was at least partially explained by examining the intervening effects of attitudes toward transfer and self-efficacy. Conclusions: The study findings carry important implications for targets of clinical intervention to assist young adults with IBD in engaging in their health care and ultimately transferring into adult care. [ABSTRACT FROM AUTHOR]

(1) Background: There has been significant recent interest in the potential role of social robots (SRs) in special education. Specific Learning Disorders (SpLDs) have a high prevalence in the student population, and early intervention with personalized special educational programs is crucial for optimal academic achievement. (2) Methods: We designed an intense special education intervention for children in the third and fourth years of elementary school with a diagnosis of a SpLD. Following confirmation of eligibility and informed consent, the participants were prospectively and randomly allocated to two groups: (a) the SR group, for which the intervention was delivered by the humanoid robot NAO with the assistance of a special education teacher and (b) the control group, for which the intervention was delivered by the special educator. All participants underwent pre- and post-intervention evaluation for outcome measures. (3) Results: 40 children (NAO = 19, control = 21, similar baseline characteristics) were included. Pre- and post-intervention evaluation showed comparable improvements in both groups in cognition skills (decoding, phonological awareness and reading comprehension), while between-group changes favored the NAO group only for some phonological awareness exercises. In total, no significant changes were found in any of the groups regarding the emotional/behavioral secondary outcomes. (4) Conclusion: NAO was efficient as a tutor for a human-supported intervention when compared to the gold-standard intervention for elementary school students with SpLDs. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures are gaining increasing importance in clinical research and quality control. Clinical impairment through limb deformities can appear in various forms. This study aimed at translating and culturally adaptating the Limb Deformity-Scoliosis Research Society (LD-SRS) patient-reported outcome measure (PROM) into German by following the scientific rigor of the cross-cultural adaptation process as well as ensuring the reliability of the translated version. The LD-SRS is applicable in children and adults. Methods: The translation was performed in accordance with the creators of the LD-SRS following the Professional Society for Health Economics and Outcomes Research (ISPOR) guidelines for translation and cultural adaptation. Two forward translations were performed, and after a consensus meeting, a professional translator translated the PROM back to English. The creators reviewed the back translation of the preliminary German version. Thirty patients with upper and lower limb deformities participated in cognitive debriefing interviews. The version was proofread and, finally, the test-retest reliability was estimated. Results: The mean age was 19 years (range 6–61). Twenty-six patients (87%) completed the retest after 6 days (range 3–26). The internal consistency was estimated with a Cronbach's alpha of 0.96 (range 0.94–0.97), and the intraclass correlation was 0.92 (range 0.89–0.94), indicating an excellent reliability. The scores were normally distributed. Thereafter, the German version was proofread and finalized. Conclusions: The German translation and cross-cultural adaptation of the LD-SRS score resulted in a high reliability and internal consistency. The German LD-SRS score is readily usable and may be applied in future studies of German-speaking limb deformity patients. [ABSTRACT FROM AUTHOR]

Simple Summary: Radiotherapy is widely used as treatment for localized prostate cancer. Due to a high incidence and a good survival after treatment, a large number of prostate cancer survivors are at risk of developing late radiation toxicity. Symptoms may significantly affect quality of life; therefore, the monitoring of toxicities and evaluating their impact are increasingly important matters. Toxicities have always been assessed by physicians, but there is a growing interest in the use of questionnaires to be completed by patients themselves, so-called patient-reported outcome measures. The aim of this study was to compare both outcomes in long-term prostate cancer survivors, and to determine which outcome correlates best with a biological predictor of late radiation toxicity. In symptomatic patients, we found a low agreement; patients assigned greater severity to symptoms than the trial physician assistant did. Neither outcome correlated with the biological predictor. Consideration of both perspectives seems warranted to provide the best care. Patient-reported outcome measures (PROMs) are advocated for the monitoring of toxicity after radiotherapy. However, studies comparing physician- and patient-reported toxicity show low concordance. In this study, we compared physician- and patient-reported toxicity in long-term prostate cancer survivors after radiotherapy, and we determined the correlation with a presumable risk factor for late toxicity: γ-H2AX foci decay ratio (FDR). Patients formerly included in a prospective study were invited to participate in this new study, comprising one questionnaire and one call with a trial physician assistant. Concordance was calculated for seven symptoms. Gamma-H2AX FDRs were determined in ex vivo irradiated lymphocytes in a previous analysis. Associations between FDR and long-term prevalence of toxicity were assessed using univariable logistic regression analyses. The 101 participants had a median follow-up period of 9 years. Outcomes were discordant in 71% of symptomatic patients; in 21%, the physician-assessed toxicity (using CTCAE) was higher, and, in 50%, the patients reported higher toxicity. We did not find a correlation between presence of toxicity at long-term follow-up and FDR. In conclusion, patients assigned greater severity to symptoms than the trial physician assistant did. Consideration of both perspectives may be warranted to provide the best care. [ABSTRACT FROM AUTHOR]

The evaluation of the patient's experience is becoming increasingly important as a better patient experience can improve the quality of the health service delivered. Patient-reported experience measures (PREMs) are self-report assessment tools provided to patients about their experience during any health event. There are few PREM instruments in the field of gastrointestinal endoscopy, and none is specific for endoscopic ultrasound (EUS). This study aims to develop a questionnaire to evaluate the experience of patients undergoing EUS, identifying and prioritizing the factors related to the patient's experience. The study will consist of several phases: (A) tool creation; (B) face and content validity; (C) ranking: to evaluate the relevance of the identified questions in the previous phase; (D) questionnaire creation and validity testing. The final output will be the production of a specific tool that can be used to measure patients' experience during EUS. This questionnaire may become a relevant part of actions taken to measure the quality of care provided to patients undergoing EUS. Furthermore, correlation between health care providers' and patients' views of the relevance of the included items will allow optimization of empathetic and psychological aspects. [ABSTRACT FROM AUTHOR]

Hematopoietic stem cell transplantation (HSCT) requires an intensive pre- and post-procedure course that leads to symptoms including fatigue, nausea/vomiting, and pain, all of which interfere significantly with activities of daily living. These symptoms place a substantial burden on patients during the time period surrounding transplant as well as during long-term recovery. The MD Anderson Symptom Inventory (MDASI) is a symptom-reporting survey that has been successfully used in adult patients with cancer and may have utility in the adolescent and young adult (AYA) population. At the Children's Cancer Hospital at MD Anderson Cancer Center, we adopted a modified version of the MDASI, the MDASI-adolescent (MDASI-Adol), as a standard of care for clinical practice in assessing the symptom burden of patients in the peri-transplant period. We then conducted a retrospective chart review to describe the clinical utility of implementing this symptom-screening tool in AYA patients admitted to our pediatric stem cell transplant service. Here, we report our findings on the symptom burden experienced by pediatric and AYA patients undergoing stem cell transplantation as reported on the MDASI-Adol. Our study confirmed that the MDASI-Adol was able to identify a high symptom burden related to HSCT in the AYA population and that it can be used to guide symptom-specific interventions prior to transplant and during recovery. Implementing a standard symptom-screening survey proved informative to our clinical practice and could mitigate treatment complications and alleviate symptom burden. [ABSTRACT FROM AUTHOR]

Simple Summary: Engaging in sports activities is strongly encouraged for cancer survivors. We aim to investigate the association between the level of sports activities participation post-diagnosis and quality of life (QoL) among Chinese women with early-stage breast cancer during the first five years of survival. Notably, we confirm in this work that regular participation in sports activities following cancer diagnosis may have a positive effect on patients' QoL. Evidence about the association between the level of sports activities participation post-diagnosis and quality of life (QoL) among Chinese women with early-stage breast cancer is limited. A validated modified Chinese Baecke questionnaire was used to prospectively measure sports activities among a breast cancer cohort at four time-points: baseline and 18, 36, and 60 months after diagnosis (sports activities during the previous 12 months before each interview); QoL was measured at the same time. In total, 1289, 1125, and 1116 patients were included in the analyses at 18-, 36- and 60-month follow-up, respectively. The percentages of patients who belonged to no (0 metabolic equivalent of task (MET)-hours per week), low-level (<10 MET-hours/week), and high-level (≥10 MET-hours/week) sports activities group were 20.7%, 45.5%, and 33.8% at 18-month follow-up, respectively; the corresponding figures at 36 and 60 months differed slightly. Using data from the three follow-ups, generalized estimating equation (GEE) analyses showed that higher levels of sports activities participation were associated with better QoL in several items as well as fewer symptoms. The present findings in Chinese women with breast cancer provide important evidence on the beneficial effect of regular participation in sports activities following cancer diagnosis on patients' QoL. [ABSTRACT FROM AUTHOR]

Simple Summary: Patient reported outcomes (PROs) are frequently integrated into routine toxicity monitoring in clinical studies but not so often in everyday clinical practice. Our investigation, conducted on patients with early stage breast cancer, showed disproportion between patient and physician perceptions of side effects by using a PRO questionnaire for patients and then the questionnaire with the same questions for physicians estimation. We found this result to be very important because the use of PRO in our clinical practice helped us determine the group of patients which required additional care to help them tolerate treatment-related side effects, have better quality of life during treatment and ultimately have best possible outcome. Knowledge about the patient's experience and perception of side effects and their impact on daily life is crucial for the adequate planning of interventions to provide the highest attainable levels of quality of life during oncology treatment. We conducted a study on consecutive samples of 69 early breast cancer patients treated with four cycles of neoadjuvant or adjuvant anthracycline-based chemotherapy. Patients completed the questionnaire about side effects experienced after the previous cycle of chemotherapy. The questionnaire was a modified PRO for the evaluation of treatment toxicity consisting of 18 questions related to the very common and common side effects of doxorubicin and cyclophosphamide, valued from 0 to 3 according to the subjective assessment of the patient. During the same cycles of therapy, data were also collected by the physician who completed a questionnaire consisting of the same questions as the questionnaire for patients, on the same scale. Most of the side effects reported by patients were mild to moderate in intensity, while physicians reported side effects much less frequently. The results also indicated a disproportionate reporting, in which physicians reported statistically significantly fewer side effects than patients. This study reported a level of disagreement between patients and physicians in the experience of therapy toxicity. In conclusion, use of PRO in clinical practice can help us avoid physician subjectiveness in the estimation of side effects and determine the group of patients who can benefit from additional and individualized supportive care measures, which could lead to better adherence to therapy and ultimately best outcomes. [ABSTRACT FROM AUTHOR]

Simple Summary: Moderate hypofractionated radiotherapy (HF) has become the standard fractionation scheme for most breast cancer patients. Despite comprehensive data from large, randomized trials, standardized assessment of patient reported outcome (PRO) and physiological changes after HF are largely missing. In this prospective trial focusing on radiodermatitis, HF and conventional normofractionated radiotherapy (CF) were compared using standardized Skindex-16 questionnaire in addition to CTCAE assessment and ultrasound measurement of the skin. The results of the current study complement and confirm existing evidence that HF leads to a lower degree of acute radiodermatitis and better patient reported outcome compared to CF. The current study aims to determine whether hypofractionated radiotherapy (HF) leads to lower rates of acute radiodermatitis compared to conventional normofractionated radiotherapy (CF). A total of 166 patients with invasive breast cancer or DCIS were included in a prospective cohort study. Evaluation of acute radiodermatitis was obtained before radiotherapy, at the end of the treatment (T1), and 6 weeks after the treatment (T2) using CTCAE (v5.0) scores, the Skindex-16 questionnaire, and ultrasound measurement of the skin. CTCAE and Skindex-16 scores in the CF-group were significantly higher compared to the HF group indicating more pronounced side effects at the end of the treatment (CTCAE: CF-RT 1.0 (IQR: 0.0) vs. HF-RT 0.0 (0.25); p = 0.03; Skindex-16: CF: 20.8 (IQR: 25.8); HF: 8.3 (27.1); p = 0.04). At 6 weeks after the treatment, no significant differences between the two fractionation schemes were observed. Ultrasound based assessment showed that the skin thickness in the treated breast was higher compared to the healthy breast at all time-points. However, no significant difference between HF and CF was seen either at T1 or T2. The current study complements and confirms pre-existing evidence that HF leads to a lower degree of acute radiodermatitis and better patient reported outcome compared to CF at the end of treatment. This should be considered whenever fractionation of adjuvant breast cancer treatment is being discussed. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients with complex brain tumors are regularly treated with proton therapy (PT) to obtain an optimal curative treatment with limited toxicity. Value-based oncological medicine is increasingly important, particularly when long-term survival is to be expected. The aim of our prospective study was to evaluate health-related quality of life (HRQOL) and patient reported outcomes (PROs) in patients treated with PT for brain tumors. PT only temporarily influences PROs and QoL directly following PT and lower QoL and PROs were mostly reported by patients who were already in a worse condition with symptoms related to the tumor and previous treatment, before the start of PT. This study assists in improving patient support in patients with brain tumors receiving PT. Proton therapy (PT) is delivered to complex brain tumors to obtain an optimal curative treatment with limited toxicity. Value-based oncological medicine is increasingly important, particularly when long-term survival is to be expected. This study aims to evaluate health-related quality of life (HRQOL) and patient reported outcomes (PROs) in patients treated with PT for brain tumors. Adult patients with brain tumors treated with PT filled out the EORTC-QLQ-C30 and BN20 questionnaires up to three years following PT. Toxicity was scored using the CTCAE v4.03. QoL and PRO were correlated to clinical factors. Three-year overall survival, distant brain control and local control rates were 98%, 97% and 84%, respectively. No ≥G3 acute toxicity was observed. Late PT-related ≥G3 severe toxicity occurred in seven patients (5.7%). Lower global QoL scores after PT were significantly correlated to low Karnofsky performance status (KPS) before PT (p = 0.001), surgical complications before PT (p = 0.04) and progressive disease (p = 0.017). A low QLQ-30 summary score at one year follow-up was correlated to sex (p = 0.015), low KPS before PT (p < 0.001), and central nervous system symptoms before PT (p = 0.018). Reported QLQ-BN20 neurological symptoms were correlated to lower KPS at baseline (p < 0.001) and surgical complications before PT (p = 0.03). PT-related toxicity only influenced reported symptoms directly following PT, but not QoL. Although global QoL temporarily decreased after treatment, it improved again from one year onwards. Global QoL and reported symptoms over time were not correlated with the proton therapy and were more related to preexisting symptoms and progressive disease. This study assists in improving patient support in patients with brain tumors receiving PT. [ABSTRACT FROM AUTHOR]

Simple Summary: Desmoid-type fibromatosis (DTF) is an uncommon soft tissue tumour with a high recurrence rate after resection. DTF does not metastasise, but its locally aggressive tumour growth and chronic character can cause significant morbidity. Although overall mortality is low, patients can experience a high symptom burden, making assessment of health-related quality of life (HRQoL) highly relevant. At present, data on HRQoL in DTF patients are limited. The QUALIFIED study aims to (1) pre-test a previously developed DTF-specific HRQoL tool (the DTF-QoL); (2) evaluate prevalence of HRQoL issues in adult DTF patients; and (3) identify subgroups at risk of impaired HRQoL. An international, multicentre, cross-sectional, observational cohort study will be conducted to validate the DTF-specific HRQoL questionnaire and to gain more insight into the issues experienced by DTF patients. This information will help to improve clinical practice, symptom control and patient satisfaction. When validated, the DTF-QoL can be used in both clinical and research settings to evaluate HRQoL of DTF patients. Sporadic desmoid-type fibromatosis (DTF) is a rare soft tissue tumour with an unpredictable clinical course. These tumours are incapable of metastasising, but their local aggressive tumour growth and tendency to recur locally can result in a substantial symptom burden. Measuring the impact of DTF on health-related quality of life (HRQoL) can be challenging due to the variable clinical presentation of the disease. Therefore, a HRQoL instrument assessing DTF-specific issues is needed. The QUALIFIED study aims to (1) pre-test a previously developed DTF-specific HRQoL tool (the DTF-QoL); (2) evaluate prevalence of HRQoL issues in adult DTF patients; and (3) identify subgroups at risk of impaired HRQoL. This study (NCT04289077) is an international, multicentre, cross-sectional, observational cohort study. Patients ≥ 18 years with sporadic DTF from the Netherlands and the United Kingdom will be invited to complete a set of questionnaires specifically composed for this patient group. Questionnaires will be completed using PROFILES (Patient Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship). Analyses will include testing the psychometric properties of the DTF-QoL and evaluating the prevalence of HRQoL issues using the DTF-QoL, EORTC QOL-C30 and EQ-5D-5L, among other questionnaires. This study will provide insight into HRQoL issues experienced by patients with DTF. Awareness of these issues and the implementation of the DTF-QoL in research and clinical practice can help to improve overall HRQoL and to provide personalised care. [ABSTRACT FROM AUTHOR]