Truth and dare: patients dare to tell the truth when using PROMs in clinical practice.

PURPOSE: As patient-reported outcome measures (PROMs) are increasingly used in clinical practice for screening, monitoring, and management, the potential for response bias has been raised (e.g., over-reporting problems for attention, under-reporting to avoid treatment changes/discontinuation). We investigated whether patients systematically bias their responses when they know clinicians will review their PROM results. METHODS: We conducted secondary analyses of three experimental studies evaluating PROMs in adult and pediatric care. Prior to PROM completion, intervention group patients were informed that the results would be shown to their clinicians ("feedback" arm), whereas control group patients were told that their clinicians would not see their responses ("no feedback" arm). Independent sample t-tests compared the "feedback" and "no feedback" arms' PROM scores at baseline. Effect sizes and 95% confidence intervals were estimated using Cohen's d statistics with Hedges' g correction, and effect sizes > 0.50 were considered clinically relevant. RESULTS: Across the 29 domains assessed in the three studies, no between-arm differences reached an effect size of ± 0.50. Only 3/29 effect sizes exceeded ± 0.30. The confidence intervals for 14 domains included ± 0.50, with 4 favoring the "no feedback" arm and 10 favoring the "feedback" arm. Two domains reached statistical significance, one favoring the "no feedback" arm and one favoring the "feedback" arm. CONCLUSION: This study does not support the hypothesis that patients systematically bias their PROM responses if they know that clinicians will see their results. These findings support using PROMs in clinical practice as a valid mechanism to promote patient-centered care.

Patient-Reported Outcome Measures for Pelvic Organ Prolapse: A Systematic Review Using the COnsensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) Checklist.

BACKGROUND: Patient-reported outcome measures (PROMs) are recommended to measure the impact of a health condition or intervention effectiveness as they aim to capture what is most meaningful to patients. Several PROMs are used to evaluate pelvic organ prolapse (POP)-related domains, yet the measurement properties of these instruments have not been fully explored with a rigorous analysis of the methodological quality and quality of evidence. OBJECTIVE: To conduct a systematic review reporting on the measurement properties of PROMs used for the assessment of POP-related domains in accordance with the COSMIN guidelines. SEARCH STRATEGY: Five databases were searched from inception to December 2023. SELECTION CRITERIA: Studies were eligible if they involved (1) at least one group of female adults diagnosed with or presenting with symptoms of POP; (2) a self-reported outcome measure (PROMs, questionnaires) to evaluate POP-related domains; and (3) at least one measurement property. DATA COLLECTION AND ANALYSIS: Methodological quality and measurement quality were assessed using the COSMIN risk of bias (ROB) checklist and the COSMIN criteria for good measurement properties. MAIN RESULTS: A total of 13 PROMs were included. The BIPOP had the lowest ROB for Content Validity. The POP-SS was the only PROM with sufficient evidence of adequate construct validity and responsiveness to be used in both surgical and conservative management settings. CONCLUSION: This original work identified a gap in evidence regarding the measurement qualities of identified PROMs used in the POP population.

Positive experiences with the use of an eHealth smartphone application during the treatment of an abdominal aortic aneurysm.

OBJECTIVE: To evaluate the patient perceived satisfaction and feasibility of a personalized eHealth application (app) for abdominal aortic aneurysm (AAA) patients undergoing surgery. METHODS: Patients were offered to download the app prior to undergoing AAA surgery, in a prospective single centre cohort study, using a mixed methods sequential explanatory design. It offers information via the timely delivery of push notifications with text, images, and videos. The information includes chapters regarding the AAA, surgical techniques (endovascular aneurysm repair and open surgical repair), and perioperative lifestyle advice such as; physical exercise programmes, healthy and protein rich diet, geriatric care, and to stop smoking or drinking alcohol. RESULTS: The app was installed by 59/65 patients (91%). After installation, six patients deactivated the app (10%). The mean age was 74 years (SD = 7) and 85% of patients were male. The app was opened a median of 67 times (interquartile range [IQR] 33-127) and with a median time interval of 50 hours (IQR 28-74). Overall, 90% (53/59) completed a satisfaction questionnaire. On a numeric rating scale from 0 to 10, the median scored satisfaction for guidance was 8 (IQR 6-8), provided information was 8 (IQR 6-8), usefulness was 7 (IQR 6-8.5), and for recommending it to others 8 (IQR 6-9). Using purposeful sampling, seven patients underwent a semi-structured interview on user-experience of the app. They described experiencing positive changes to lifestyle habits, and appreciating the ability to share it with loved ones or informal caregivers. Several areas of improvement were reported. CONCLUSION: The personalized eHealth app is feasible in older AAA patients and valued as a useful supplement to the standard of care. We argue that the app aids in managing a prehabilitation programme, aids in the digital transformation of healthcare, and thereby decreases the workload of hospital staff.

Health-related Quality of Life Assessment in Renal Cell Cancer: A Scoping Review.

BACKGROUND AND OBJECTIVE: In oncology, patient-reported outcome measures (PROMs) capturing health-related quality of life (HRQOL) play an increasing role in clinical trials, drug approval, and policy making. This scoping review aimed to identify and elaborate on HRQOL-focussed PROMs used in renal cell cancer (RCC) clinical trials. METHODS: MEDLINE, Web of Science, PsychINFO, Academic Search Elite, CINAHL, Embase, and the Cochrane Library were searched systematically for original peer-reviewed articles on clinical trials including RCC patients and using PROMs, published between 1950 and 2023. Prespecified trial characteristics and information on the PROMs used were extracted. Frequencies and proportions of categorical data, and ranges and medians of continuous variables were calculated. KEY FINDINGS AND LIMITATIONS: Of the 48 unique studies included, the majority followed a randomised controlled design (34, 71%) and evaluated systemic treatments (38, 79%). The trials used 27 different PROMs (max = 6, median = 2), of which only 4 (15%) were developed specifically for kidney cancer patients. Of the trials, 46% did not use any RCC-specific PROM. European Quality of Life-5 Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI) -15/19-item version, FKSI-Disease Related Symptoms, and Functional Assessment of Cancer Therapy-General (FACT-G) were the most frequently used questionnaires, with pain, ability to work, fatigue, worry, and sleep quality being the most commonly assessed issues. CONCLUSIONS AND CLINICAL IMPLICATIONS: A variety of PROMs are used in RCC patients, hindering interpretability across trials. The PROMs used differ in terms of both the domains assessed and how the issues are translated into questionnaire items. Though RCC-specific PROMs exist, these have flaws in terms of relevance to patients. To answer predefined relevant HRQOL research questions, revised RCC-specific PROMs and standardisation of their integration into clinical trials are warranted. PATIENT SUMMARY: Researchers are more and more interested in the health-related quality of life of kidney cancer patients and use questionnaires to measure it. This review shows that there are many different health-related quality of life questionnaires that are used in different combinations in clinical trials for kidney cancer patients. This makes it very difficult to compare these study results and draw reliable conclusions for the actual clinical treatment. It was even found that some of the questionnaires used do not capture things that patients actually consider important (eg, emotional issues such as dealing with thoughts about cancer and depression). Therefore, more work needs to be done to develop questionnaires that ask what is really important to kidney cancer patients' health-related quality of life. If these questionnaires are used in a consistent way in clinical trials, the results can be better compared. This will help treat kidney cancer patients in the best possible way.

Implementing a Streamlined Hypoglossal Nerve Stimulator Pathway: Cost, Time to Surgery, and Outcomes.

Objective: To evaluate the costs, time to surgery, and clinical outcomes associated with implementing a streamlined hypoglossal nerve stimulator (HGNS) implantation pathway. Study Design: Retrospective cohort study. Setting: Single tertiary care center in the United States from 2016 to 2023. Methods: Patients with a lack of complete concentric collapse of the velum during volitional snore on in-office laryngoscopy qualified for the streamlined HGNS pathway. This pathway consisted of confirmatory drug-induced sleep endoscopy (DISE) followed immediately by HGNS implantation during the same surgical encounter. Outcomes were compared to patients in the traditional pathway (standalone DISE followed by HGNS implantation on a later date). Results: A total of 68 patients (13 streamlined, 55 traditional) with obstructive sleep apnea who underwent HGNS implantation were included. Patients were predominately male (70.6%) and White (95.6%) and had a mean (SD) age of 63.5 (10.0) years. The streamlined pathway was associated with a significant reduction in both hospital costs (mean difference $9258, 95% confidence interval [CI]: 3690-14,825; P = .002) and time to surgery (mean decrease of 3.82 months, 95% CI: 0.83-6.80 months; P = .013) compared to the traditional pathway. Patients in both groups had reduction in apnea-hypopnea index and Epworth Sleepiness Scale score, with no significant differences in comparisons between groups. Conclusion: In select patients, the streamlined HGNS pathway may expedite time to surgery and reduce hospital costs with comparable clinical outcomes to a traditional 2-stage pathway. Further research is warranted to validate patient selection and better understand longitudinal outcomes.

Forefoot inflammation in recent-onset ACPA-positive and ACPA-negative RA: clinically similar, but different in underlying inflamed tissues.

OBJECTIVES: Although joint swelling is traditionally interpreted as synovitis, recent imaging studies showed that there is also inflammation of tenosynovium and intermetatarsal bursae in the forefoot. We aimed to increase our understanding of differences and similarities regarding forefoot involvement between ACPA-positive and ACPA-negative rheumatoid arthritis (RA) at diagnosis. Therefore, we (1) compared metatarsophalangeal (MTP) joint counts, walking disabilities and inflamed tissues between ACPA groups and (2) studied associations of joint swelling/tenderness and walking disabilities with underlying inflamed tissues within ACPA groups. METHODS: 171 ACPA-positive and 203 ACPA-negative consecutively diagnosed patients with RA had a physical joint examination (swollen joint count-66/tender joint count-68), filled a Health Assessment Questionnaire including the domain walking and underwent MRI of the MTP joints at diagnosis. Synovitis, tenosynovitis, osteitis and intermetatarsal bursitis (IMB) were assessed. Findings in age-matched healthy controls were applied to define abnormalities on MRI. RESULTS: While ACPA-negative RA patients had more swollen joints (mean SJC 8 vs 6 in ACPA-positives, p=0.003), the number of swollen MTP joints was similar (mean 1 in both groups); walking disabilities were also equally common (49% vs 53%). In contrast, inflamed tissues were all more prevalent in ACPA-positive compared with ACPA-negative RA. Within ACPA-positive RA, IMB was associated independently with MTP-joint swelling (OR 2.6, 95% CI 1.4 to 5.0) and tenderness (OR 3.0, 95% CI 1.8 to 5.0). While in ACPA-negatives, synovitis was associated independently with MTP-joint swelling (OR 2.8, 95% CI 1.4 to 5.8) and tenderness (OR 2.5, 95% CI 1.3 to 4.8). Tenosynovitis contributed most to walking disabilities. CONCLUSIONS: Although the forefoot of ACPA-positives and ACPA-negatives share clinical similarities at diagnosis, there are differences in underlying inflamed tissues. This reinforces that ACPA-positive and ACPA-negative RA are different entities.

Development of a web-based ecological momentary assessment tool to measure day-to-day variability of the symptoms in patients with Sjögren's disease.

OBJECTIVES: To develop and validate a web-based ecological momentary assessment (EMA) tool to enhance symptoms monitoring among patients with Sjögren's disease (SjD). METHODS: Consecutive adults with SjD were enrolled in this pilot observational study. Participants used the WebApp over a 3-month period, for the daily collection of individual EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scales and separate assessment of eyes and mouth dryness, using 0-10 numerical scales. Primary outcome was the measure of the interdaily variability of symptoms. Data collected through the WebApp were compared with those obtained with paper-based questionnaires administered during a final visit, using distinct approaches (predicted error, maximum negative error and maximum positive error). User experience was assessed using the System Usability Scale (SUS) score. RESULTS: Among the 45 participants, 41 (91.1%) were women. Median age was 57 years (IQR: 49-66). Daily variability of symptoms ranged between 0.5 and 0.8 points across the scales. Over the 3-month period, the predicted error ranged between -1.2 and -0.3 points of the numerical scales. The greatest differences were found for fatigue (-1.2 points (IQR: -2.3 to -0.2)) and ESSPRI score (-1.2 points (IQR: -1.7 to -0.3)). Over the last 2 weeks, the predicted error ranged between - 1.2 and 0.0 points. Maximum negative error ranged between -2.0 and -1.0 points, and maximum positive error between -0.3 and 0.0 points. Median SUS score was 90 (IQR: 85-95). CONCLUSION: Our results demonstrate the usability and the relevance of our web-based EMA tool for capturing data that closely reflects daily experiences of patients with SjD.

Evaluation of the Turkish version of measure of activity performance of the hand (MAP-Hand) in people with rheumatoid arthritis.

BACKGROUND: Assessing hand function is essential for many people with rheumatoid arthritis (RA). The Measure of Activity Performance of the Hand (MAP-Hand) allows a rapid evaluation of the hand. OBJECTIVE: To translate the MAP-Hand into Turkish and investigate its psychometric properties. METHOD: The MAP-Hand was translated into Turkish by using established translation guidelines. The questionnaire was pilot tested in 30 people with RA. Then, 185 adults with RA (150 women) participated in the study. Physical characteristics (age, sex, body mass index), socio-demographic information (education, employment, marital status), disease-related characteristics (RA medications, disease activity, duration of disease), hand strength (grip and pinch strengths), and patient reported outcome measures regarding pain, hand/upper extremity function, and general health status were collected. The Turkish MAP-Hand was re-administered to 109 participants in the following week. RESULTS: The Turkish MAP-Hand was acceptable and feasible to administer, and showed excellent internal consistency (Cronbach's α = 0.952, confidence interval, CI = 0.942 to 0.962, p < .001). The unidimensionality of the Turkish MAP-Hand was confirmed by Rasch Analysis. Test-retest reliability was excellent (Intraclass Correlation Coefficient = 0.908, CI = 0.868 to 0.936, p < .001). The Turkish MAP-Hand showed moderate negative correlations with hand strength (Pearson's r between -0.511 and -0.572, p < .05), and fair to excellent positive correlations with disease activity, pain, hand/upper extremity function, and general health status (Pearson's r between 0.437 and 0.915, p < .05). CONCLUSION: The Turkish Map-Hand demonstrated adequate psychometric properties (internal consistency, structural validity, test-retest reliability, convergent validity) supporting the utility of its use for evaluating the activity performance of the hand in people with RA.

Advancing patient-centered cancer care: a systematic review of electronic patient-reported outcome measures.

Background: Electronic Patient-Reported Outcome Measures (ePROMs) have emerged as valuable tools in cancer care, facilitating the comprehensive assessment of patients' physical, psychological, and social well-being. This study synthesizes literature on the utilization of ePROMs in oncology, highlighting the diverse array of measurement instruments and questionnaires employed in cancer patient assessments. By comprehensively analyzing existing research, this study provides insights into the landscape of ePROMs, informs future research directions, and aims to optimize patient-centred oncology care through the strategic integration of ePROMs into clinical practice. Methods: A systematic review was conducted by searching peer-reviewed articles published in academic journals without time limitations up to 2024. The search was performed across multiple electronic databases, including PubMed, Scopus, and Web of Science, using predefined search terms related to cancer, measurement instruments, and patient assessment. The selected articles underwent a rigorous quality assessment using the Mixed Methods Appraisal Tool (MMAT). Results: The review of 85 studies revealed a diverse range of measurement instruments and questionnaires utilized in cancer patient assessments. Prominent instruments such as the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) were frequently referenced across multiple studies. Additionally, other instruments identified included generic health-related quality of life measures and disease-specific assessments tailored to particular cancer types. The findings indicated the importance of utilizing a variety of measurement tools to comprehensively assess the multifaceted needs and experiences of cancer patients. Conclusion: Our systematic review provides a comprehensive examination of the varied tools and ePROMs employed in cancer care, accentuating the perpetual requirement for development and validation. Prominent instruments like the EORTC QLQ-C30 and PRO-CTCAE are underscored, emphasizing the necessity for a thorough assessment to meet the multifaceted needs of patients. Looking ahead, scholarly endeavours should prioritize the enhancement of existing tools and the creation of novel measures to adeptly address the evolving demands of cancer patients across heterogeneous settings and populations.

The evaluation of daily activity questionnaire for stroke survivors: cross-cultural adaptation, content validity and digitisation.

OBJECTIVE: The study's objective was to culturally adapt and digitise the Evaluation of Daily Activity Questionnaire (EDAQ), originally designed for rheumatoid arthritis and various other musculoskeletal conditions, creating a version for stroke survivors (EDAQ-SS). This adaptation also aimed to develop a comprehensive electronic Patient Reported Outcome Measure (ePROM) intended to refine stroke survivors' self-assessment of their daily activity limitations. MATERIALS AND METHODS: Cross-cultural adaptation of the EDAQ was completed by a review of expert panel, which included healthcare professionals to increase the clarity and relevancy of the items, followed by cognitive debriefing interviews with British stroke survivors to rate their understanding of the questionnaire items. After developing the paper version of the questionnaire, this was digitised (eEDAQ-SS) and disseminated online via the Stroke Survivors Hub (SSHUB). Content validity of the EDAQ-SS was evaluated using the International Classification of Functioning (ICF) Core Set for Stroke. RESULTS: The expert panel meeting (n:11) and cognitive debriefing interviews with stroke survivors (n:10) resulted in an EDAQ-SS with 160 items across 15 domains, which was understandable and relevant to stroke survivors. The SSHUB was deemed to be a user-friendly platform, providing easy access to eEDAQ-SS and aid self-assessment of daily activities of stroke survivors. Mapping the EDAQ-SS items to the ICF Core Set for Stroke demonstrated good content validity with 44/55 matching categories. CONCLUSION: The EDAQ-SS offers a comprehensive measure for self-assessment, which may serve to guide stroke survivors' self-management by overcoming limitations of existing PROMs. Further psychometric testing of the EDAQ-SS and wider testing of the digital version is recommended. CONTRIBUTION OF THE PAPER.

Development of CARRA/PReS-endorsed consensus Core and Expanded Datasets in childhood-onset systemic lupus erythematosus for international registry-based research.

OBJECTIVES: Childhood-onset systemic lupus erythematosus (cSLE), representing 15%-20% of individuals with SLE, has been difficult to study globally due to differences between registries. This initiative, supported by Childhood Arthritis Rheumatology Research Alliance (CARRA) and Paediatric Rheumatology European Society (PReS), aims to create Core and Expanded cSLE Datasets to standardise and enhance research worldwide. METHODS: 21 international cSLE experts and 4 patients participated in a Delphi process (questionnaires, 2 topic-specific focus groups and 3 virtual consensus meetings) to create 2 standardised cSLE datasets. The Core cSLE Dataset was designed to include data essential to meaningful clinical research across many settings. The Expanded cSLE Dataset was designed for centres able to consistently collect data to address broader research questions. Final data items for the Core and Expanded datasets were determined by consensus defined as >80% agreement) using an adapted nominal group technique and voting. RESULTS: The resulting Core cSLE Dataset contains 46 items, including demographics, clinical features, laboratory results, medications and significant adverse events. The Expanded cSLE Dataset adds 26 additional items and includes patient-reported outcomes. Consensus was also achieved regarding the frequency and time points for data collection: baseline, quarterly follow-up visits, annually and flare visits. CONCLUSION: Standardised Core and Expanded cSLE Datasets for registry-based international cSLE research were defined through the consensus of global experts and patient/caregiver representatives, endorsed by CARRA and PReS. These datasets incorporate disease-specific and patient-specific features, optimised for diverse settings to facilitate international collaborative research for children and adolescents with SLE worldwide.

The Role of Biomarkers in Predicting Outcomes of Anterior Cruciate Ligament Reconstruction: A Systematic Review.

Background: Anterior cruciate ligament (ACL) injury is frequently associated with injuries to other parts of the knee, including the menisci and articular cartilage. After ACL injury and reconstruction, there may be progressive chondral degradation. Biomarkers in blood, urine, and synovial fluid can be measured after ACL injury and reconstruction and have been proposed as a means of measuring the associated cellular changes occurring in the knee. Purpose: To systematically review the literature regarding biomarkers in urine, serum, or synovial fluid that have been associated with an outcome measure after ACL reconstruction. Study Design: Systematic review; Level of evidence, 3. Methods: This review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The MEDLINE, Embase, CINAHL, and Web of Science databases were searched to identify studies published before September 2023 that reported on patients undergoing ACL reconstruction where a biomarker was measured and related to an outcome variable. Of 9360 results, 16 studies comprising 492 patients were included. Findings were reported as descriptive summaries synthesizing the available literature. Results: A total of 45 unique biomarkers or biomarker ratios were investigated (12 serum, 3 urine, and 38 synovial fluid; 8 biomarkers were measured from >1 source). Nineteen different outcome measures were identified, including the International Knee Documentation Committee Subjective Knee Form, Knee injury and Osteoarthritis Outcome Score, numeric pain scores, radiological outcomes (magnetic resonance imaging and radiography), rates of arthrofibrosis and cyclops lesions, and gait biomechanics. Across the included studies, 17 biomarkers were found to have a statistically significant association (P < .05) with an outcome variable. Serum interleukin 6 (s-IL-6), serum and synovial fluid matrix metalloproteinase-3 (s-MMP-3 and sf-MMP-3), urinary and synovial fluid C-terminal telopeptide of type 2 collagen (u-CTX-II and sf-CTX-II), and serum collagen type 2 cleavage product (s-C2C) showed promise in predicting outcomes after ACL reconstruction, specifically regarding patient-reported outcome measures (s-IL-6 and u-CTX-II), gait biomechanical parameters (s-IL-6, sf-MMP-3, s-MMP-3, and s-C2C), pain (s-IL-6 and u-CTX-II), and radiological osteoarthritis (ratio of u-CTX-II to serum procollagen 2 C-propeptide). Conclusion: The results highlight several biomarkers that have been associated with clinically important postoperative outcome measures and may warrant further research to understand if they can provide meaningful information in the clinical environment.

Reliability and validity of patient-reported outcome measures in assessing knee osteoarthritis in the Chinese population: A systematic review.

Objective: Knee osteoarthritis (KOA) is a prevalent condition in China, necessitating effective assessment tools for treatment outcomes. This study systematically reviews and analyzes the reliability, validity, and selection of patient-reported outcome measures (PROMs) for evaluating KOA. Methods: Following PRISMA guidelines, a literature search was conducted across seven databases, including CNKI, PubMed, and Embase, covering publications from December 2012 to December 2022. The methodological quality of the studies was assessed using the COSMIN checklist. Results: Twenty-one studies met the inclusion criteria, involving eight types of KOA PROMs. The Oxford Knee Score (OKS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were the most frequently utilized, appearing in nine and four studies, respectively. OKS achieved a "strong" rating in internal consistency, test-retest reliability, content validity, responsiveness, and measurement error, while WOMAC received a "strong" rating in internal consistency, test-retest reliability, and content validity, with a "moderate" rating in structural validity. Conclusion: Both OKS and WOMAC are effective PROMs for evaluating KOA in China. However, the choice of a specific tool should be based on the study's objectives and the practical context, considering each tool's reliability, validity, and other measurement properties.

Health-related quality of life among women and men living with migraine: a Canada-wide cross-sectional study.

BACKGROUND: Migraine is a prevalent neurologic disorder that affects women more than men. Examining health-related quality of life (HRQoL) by gender can aid decision makers in prioritizing future treatment and prevention programs. We aimed to quantify HRQoL by different levels of migraine disability and by gender. METHODS: As part of a Canada-wide cross-sectional study, we administered an online survey to employed adults who self-reported a diagnosis of migraine. Migraine disability level was assessed using the Migraine Disability Assessment questionnaire (MIDAS). MIDAS scores were used to categorize respondents as having little to no, mild, moderate, or severe level of migraine-related disability. Physical and mental component summary scores (PCS and MCS) and health utilities were derived from responses to the Veterans Rand 12 Item Health Survey. PCS, MCS, and health utilities were summarized by migraine-related disability levels and gender. Covariate-adjusted linear regressions were used to examine the association between migraine disability level and health utility by gender. RESULTS: A total of 441 participants completed the survey. The sample was predominantly women (60.1%), White race (75.5%), and had a mean age of 37 years. Mean health utility, PCS, and MCS scores were 0.61 (0.22), 45.0 (7.7), and 43.4 (11.0), respectively. All three scores decreased with increased migraine disability level. Gender differences on HRQoL within each migraine disability level were not statistically significant, except in the little to no disability level where women had lower mean MCS scores and health utility relative to men [mean (SD) MCS: women 44.0 (11.3); men 55.1 (8.1), p < 0.001; health utility: women 0.66 (0.18); men 0.81 (0.18), p < 0.001]. Linear regressions showed women with severe migraine-related disability had reduced health utility compared to women with little to no disability [adjusted difference: -0.16 (95%CI -0.24,-0.09)]. Associations among men increased in magnitude with migraine disability level [adjusted differences: mild - 0.16 (95%CI -0.24,-0.09); moderate - 0.18 (95%CI -0.26,-0.10); severe - 0.28 (95%CI -0.37,-0.20)]. CONCLUSIONS: Findings contribute to the literature on the association between migraine disability level and HRQoL by examining trends by gender. Model results emphasize the importance of future treatments reducing severe disability due to migraine among both women and men.

Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study.

INTRODUCTION: Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard. METHODS AND ANALYSIS: In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn's disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test. ETHICS AND DISSEMINATION: This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20-085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT05886322.

[What determines the overall quality of postoperative pain management? A question of perspective]. / Was ist ausschlaggebend für die Gesamtqualität der postoperativen Schmerztherapie? Eine Frage der Perspektive.

BACKGROUND: The outcome domains pain intensity, pain-related interference, side effects, (treatment) information, participation and personal interaction have all been identified as relevant factors in the management of perioperative pain. However, it is not yet clear which of these are particularly significant for the subjectively perceived overall quality of postoperative pain management. AIM: A newly developed questionnaire was used in this cross-sectional study to assess the relevance of these domains for patients and compare the relevance to healthcare professionals (HCP). METHODS: The patient survey (n = 40) was conducted on the first postoperative day at Jena University Hospital, Germany. In order to investigate group differences, 63 HCP (disciplines: n = 15 anaesthesiology, n = 17 surgery, n = 31 nursing) were recruited. The questionnaire primarily included all pairwise comparisons between the domains with regard to the overall quality of postoperative pain management. The resulting sum scores for each domain were the primary outcome measure, which were analysed using generalized estimating equations. RESULTS: Within the group of patients, there were significant differences in the prioritization of the six outcome domains, with personal interaction followed by intensity and interference having received the highest ratings. There were also significant differences within the domains between the perspectives of patients and HCP, as well as between the HCP themselves. CONCLUSIONS: The study demonstrates that personal interaction and the reduction of pain intensity and interference are three key factors that are significant for patients' experience of postoperative pain management. However, the extent to which the harmonisation of these three factors with those given prominence by HCP would positively impact postoperative pain management remains unclear and should be investigated further.

Translation and Validation of Dizziness Handicap Inventory in Hindi Language.

The dizziness handicap inventory (DHI) is a widely used questionnaire for assessing the impact of dizziness on daily life. There is a need for validated translations of the DHI to accommodate diverse linguistic populations, enabling clinical and research comparisons. This study aimed to translate and validate the DHI into Hindi language. The DHI was translated into Hindi following established guidelines. The translated version underwent validation among Hindi-speaking patients presenting with dizziness at an outpatient ENT clinic in this cross-sectional study. Reliability and validity analyses were conducted, including Cronbach's alpha, split-half reliability, and factor analysis. A total of 153 participants completed the DHI-Hindi, with a mean score of 37.28 (SD = 15.63). Ceiling and floor effects were absent. The Cronbach's alpha coefficient for the overall scale was 0.785, indicating good reliability. Factor analysis revealed a three-factor solution, consistent with previous studies, indicating good construct validity.The translation and validation process yielded a reliable and valid version of the DHI in Hindi language, suitable for assessing the impact of dizziness in Hindi-speaking population.

Quality of life and psychological distress in end-stage renal disease patients undergoing hemodialysis and transplantation.

BACKGROUND: Among diverse profound impacts on patients' quality of life (QoL), end-stage renal disease (ESRD) frequently results in increased levels of depression, anxiety, and stress. Renal replacement therapies such as hemodialysis (HD) and transplantation (TX) are intended to enhance QoL, although their ability to alleviate psychological distress remains uncertain. This research posits the existence of a significant correlation between negative emotional states and QoL among ESRD patients, with varying effects observed in HD and TX patients. AIM: To examine the relationship between QoL and negative emotional states (depression, anxiety, and stress) and predicted QoL in various end-stage renal replacement therapy patients with ESRD. METHODS: This cross-sectional study included HD or TX patients in the Eastern Region of Saudi Arabia. The 36-item Short Form Survey and Depression Anxiety Stress Scale (DASS) was used for data collection, and correlation and regression analyses were performed. RESULTS: The HD and TX transplantation groups showed statistically significant inverse relationships between QoL and DASS scores. HD patients with high anxiety levels and less education scored low on the physical component summary (PCS). In addition, the results of the mental component summary (MCS) were associated with reduced depression. Compared with older transplant patients, TX patients' PCS scores were lower, and depression, stress, and negative working conditions were highly correlated with MCS scores. CONCLUSION: The findings of this study revealed notable connections between well-being and mental turmoil experienced by individuals undergoing HD and TX. The PCS of HD patients is affected by heightened levels of anxiety and lower educational attainment, while the MCS of transplant patients is influenced by advancing age and elevated stress levels. These insights will contribute to a more comprehensive understanding of patient support.

Patient-reported outcome measures in type 1 diabetes outpatient care.

Background: Patient-reported outcome measures (PROMs) assess how individuals perceive the disease and its impact on quality of life, representing an important complement to the metabolic evaluation in type 1 diabetes mellitus (T1DM). This study aimed to assess the PROMs and their association with metabolic control. Methods: A cross-sectional study of adults with T1DM was conducted in the outpatient Endocrinology department between October 2022 and May 2023. Clinical, demographic, and continuous glucose monitoring (CGM) data were collected. Three PROMs were applied: the diabetes psychological adjustment scale (ATT18), the World Health Organization well-being index (WHO-5), and the patient health questionnaire (PHQ-9). Descriptive and bivariate statistical analyses were performed. Results: We included 56 participants, aged 41.2 ± 14.6 years, 58 % female, and 64 % of medium-high socioeconomic class. The disease duration of the cohort was 21 ± 14.6 years, with 44.6 % on continuous subcutaneous insulin infusion (CSII) and 39.3 % presenting microvascular complications. Glycated hemoglobin of the cohort was 8.0 ± 1.4 %, time in range (TIR) 52 ± 22 %, coefficient of variation (CV) 37 ± 8 %, and median time below range (TBR) 2 %. Individuals on CSII had higher TIR (p =0.03). CV was related to TBR (ρ =0.643, p <0.001). The majority had satisfactory psychological adjustment to diabetes (ATT18 ≥60), which correlated directly with WHO-5 (r =0.511, p <0.001) and inversely with depression symptoms (r =-0.676, p <0.001). No relationships were identified between metabolic control and PROMs (p =0.63). Conclusions: Including PROMs alongside detailed metabolic evaluation allows for individualized decision-making and active patient participation in diabetes management. These results underscore the importance of preventing depression, promoting well-being, and enhancing diabetes psychological adjustment in these patients, aiming to improve their quality of life. HIPPOKRATIA 2024, 28 (1):17-21.

Longitudinal assessment of health-related quality of life after SARS-CoV-2 infection and the associations with clinical and social characteristics in a general practice population.

BACKGROUND: We aimed to investigate the longitudinal impact of COVID-19 and the effects of clinical and psychosocial factors, accounting for post-COVID conditions (PCC), on the mental and physical aspect of health-related quality of life (HRQoL) of patients diagnosed with COVID-19. METHODS: Data from the Nivel Corona Cohort were used, which includes individuals with an established SARS-CoV-2 infection that received four questionnaires over a year's time with questions regarding HRQoL (SF-12), symptoms and social characteristics. PCC was determined based on questionnaire data. Data on medical history and healthcare utilization were obtained from electronic health records from general practice. A repeated measures linear mixed model was used to explore associations between clinical and social characteristics, and the course of mental and physical HRQoL after a SARS-CoV-2 infection, taking PCC into account. RESULTS: One hundred fifty-eight individuals of whom it was possible to determine whether they had PCC or not were included in this study. Seventy-six (48.1%) developed PCC, which was associated with a persistent reduction in both physical and mental HRQoL. Hospitalization during the acute phase of the infection had a negative impact on the physical HRQoL, which decreased over time. Females, people older than 53, and those with increased resilience and mental HRQoL before infection were more likely to report a more positive mental HRQoL over time. CONCLUSION: The negative association PCC has with both mental and physical HRQoL for at least six months, calls for more research to support patients with PCC.