Symptom Burden in Patients on Maintenance Hemodialysis: Prevalence and Severity 17 Years Apart.

Objectives: The aim of this study is to compare data from two cohorts separated by a 17-year interval. We assessed the prevalence and severity of symptoms with the "dialysis symptom index" in these two groups, recruited in 2007 and 2024, to determine how advancements in dialysis therapy have influenced the symptom burden's prevalence and severity. Methods: End-stage renal diseases patients receiving maintenance hemodialysis three times a week in the hemodialysis unit of the university hospital were recruited between February and March 2007. In May 2024, in the same unit, another population sample was recruited and studied, as in 2007. The Dialysis Symptom Index (DSI) was administered to each patient, during the dialysis treatment. The DSI is made up of 30 questions, each of which addresses a specific physical or emotional symptom. The total symptom burden score, representing the total number of symptoms reported as being present, and the total symptom severity score, which represents the sum of individual severity scores, were generated for each patient. Results: We studied 71 patients in 2007 and 61 patients in 2024. The demographic, clinical and laboratory characteristics of the two study populations did not differ significantly. The total symptom burden score did not differ significantly between 2007 and 2024. The prevalence of most symptoms was similar in the two groups. The prevalence of constipation, decreased interest in sex and difficulty in becoming sexually aroused was higher in 2024 than in 2007. The total symptom severity was similar in the two periods. The severity of most symptoms was similar in the two groups. The severity of decreased interest in sex and difficulty in becoming sexually aroused was higher in 2024 than in 2007. Conclusions: The present study shows that, 17 years apart, the prevalence and severity of the symptom burden in patients on maintenance hemodialysis did not change significantly. These results suggest that studies investigating the causes and the pathogenesis of symptoms of patients on maintenance hemodialysis are urgently needed in the next future, as well as studies on therapeutic strategies.

Hispanic Cancer Survivors Exposed to Multiple Natural Disasters: Pre-Post-Disaster Changes in Anxiety, Depression, PTSD, Perceived Stress, and Physical Symptom Burden.

BACKGROUND: Studies evaluating the effects of natural disasters on cancer outcomes are scarce, especially among USA ethnic minority groups, and none have focused on the effects of concurrent natural disasters and the COVID-19 pandemic. The goal of this secondary data analysis is to explore the impact of concurrent exposure to COVID-19 and earthquakes on psychological distress and symptom burden among Puerto Rican cancer survivors. METHODS: This secondary data analysis (n = 101) was part of a longitudinal case-control cohort study (n = 402) aimed at describing unmet psychological needs among Puerto Rican cancer patients and non-cancer subjects previously exposed to Hurricane María in 2017. The research team pooled data from participants (cancer survivors and non-cancer group) from their baseline assessments and from follow-up assessments conducted during January-July 2020 (earthquake and the lockdown period). A descriptive, paired t-test, non-parametric mean rank test, and two-sided Pearson correlation analyses were performed. RESULTS: Psychological distress and cancer symptom burden diminished over time. Resilience was significantly correlated with all the psychological and symptom burden variables during both pre- and post-earthquake and COVID-19 assessment periods. CONCLUSIONS: The results support the role of resilience, social support, and post-traumatic growth as potential protective factors preventing psychological distress and diminishing cancer symptom burden among cancer survivors exposed to natural disasters and the COVID-19 pandemic.

A patient report scale research to access the symptom burden in patients with IgA nephropathy.

Patients diagnosed with IgA nephropathy (IgAN) commonly experience a substantial burden of symptoms encompassing both physical and psychological aspects. Presently, there's a dearth of standardized assessment tools to effectively gauge the extent of symptom burden in IgAN patients. Therefore, this study aims to devise an IgAN Symptom Assessment Tool that enables a comprehensive evaluation of patient symptom burden and their self-perceived severity. Employing a prospective observational design, this study conducted a survey among patients diagnosed with IgAN at a hospital in China. The research team formulated an IgAN Symptom Burden Assessment Scale and administered a questionnaire to gauge patient symptom burden. Severity assessment was conducted on a 5-point Likert scale, with higher scores indicating a more pronounced burden of symptoms. The finalized scale comprised 14 distinct symptom items, and the questionnaire survey garnered responses from 200 patients, achieving a 100% response rate. Statistical analysis unveiled that nearly all patients regarded these symptoms as prevalent and significantly impactful on their daily lives, resulting in a considerable burden. Notably, mild oliguria, moderate nasal congestion, bitter taste , throat discomfort, alongside severe manifestations such as muscle weakness, fatigue, and foamy urine, were frequently reported by patients. The findings underscore that a substantial proportion of IgAN patients grapple with a significant burden of symptoms, emphasizing the imperative for healthcare providers to prioritize symptom management and implement proactive measures to alleviate these challenges. This study presents an innovative tool tailored for evaluating symptom burden specifically in IgAN patients. Subsequent research should center on validating this tool within larger patient cohorts to optimize the efficacy of symptom management in this demographic.

Symptoms Reported by Young Adults With Asthma During Wildfire Smoke Season.

PURPOSE: The purpose of this article is to evaluate the relationship between exposure to poor air quality (AQ) and self-reported symptoms among young adults with asthma during wildfire smoke season. METHODS: Sixty seven young adults (aged 18-26 years) completed the Asthma Control Test and reported asthma symptoms at three time points (baseline, 4 weeks, and 8 weeks) during wildfire season as part of a clinical trial. Bivariate correlations between Asthma Control Test and AQ measures were examined followed by predictive linear regression. Multiple symptoms were compared between participants who experienced poor AQ and those who did not. RESULTS: Asthma control was inversely related to AQ with increased exposure to poor AQ tied to poor asthma control. A significantly greater proportion of participants reported critical respiratory symptoms when exposed to poor AQ than those who were not. DISCUSSION: Respiratory symptoms are key indicators that young adults can monitor to optimize their asthma management during wildfire smoke season.

Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation.

BACKGROUND: In the CodeBreaK 200 phase III, open-label trial, sotorasib significantly improved efficacy versus docetaxel in previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Patient-reported outcomes (PROs) for global health status, physical functioning, dyspnea, and cough favored sotorasib over docetaxel. Here, we report sotorasib's additional impact on quality of life (QOL). METHODS: In CodeBreaK 200, 345 patients who had progressed after prior therapy received sotorasib (960 mg orally daily) or docetaxel (75 mg/m2 intravenously every 3 weeks). Validated questionnaires captured patients' perception of their QOL and symptom burden for key secondary and exploratory PRO endpoints, including the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Quality-of-life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13), question GP5 from the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and 5-level EuroQOL-5 dimensions (EQ-5D-5L) including visual analog scale (EQ-5D VAS). Change from baseline to week 12 was assessed with generalized estimating equations for ordinal outcomes. RESULTS: Patients receiving sotorasib were less bothered by treatment side effects than those receiving docetaxel (odds ratio [OR] 5.7) and experienced symptoms at lower severity (pain: OR 2.9; aching muscles: OR 4.4; aching joints: OR 4.2; mouth or throat sores: OR 4.3). Further, patients' symptoms interfered less with usual/daily activities (pain: OR 3.2; aching muscles: OR 3.9; aching joints: OR 10.7). QOL remained stable with sotorasib but worsened with docetaxel (change from baseline in EQ-5D VAS score: 1.5 vs -8.4 at cycle 1 day 5 and 2.2 vs -5.8 at week 12). CONCLUSIONS: Patients receiving sotorasib reported less severe symptoms than those receiving docetaxel. In addition to improving clinical efficacy outcomes, sotorasib maintained QOL versus docetaxel, suggesting sotorasib may be a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC.

Impact of Cancer Localization on Symptom Burden and Quality of Life in Head and Neck Cancers: A Comparative Study.

Background: Head and neck cancer (HNC) is a critical concern in oncology, with notable disparities in survival rates. While the long-term symptom burden in HNC survivors and its impact on quality of life (QoL) has been explored, there is limited understanding of the influence of cancer localizations on these aspects. This study aims to elucidate the role of cancer localizations in shaping long-term outcomes in HNC patients. Methods: A cross-sectional study was conducted at the University Hospital Erlangen's Department of Otolaryngology, exploring the impact of cancer localization on symptom burden and QoL in 138 HNC patients using the University of Washington Quality of Life Questionnaire Version 4. Results: In our study of HNC patients, we investigated symptom burden across different cancer localizations, including oral cavity, oropharyngeal, hypopharyngeal, laryngeal, and cancer of unknown primary (CUP). While we found no significant variations in parameters such as pain, appearance, and activity, notable differences emerged in swallowing, speech, and salivation. Patients with oral cavity and laryngeal carcinomas had significantly higher swallowing and salivation scores compared to those with oropharyngeal carcinoma and CUP, while speech-related symptoms were lower for oral cavity and laryngeal carcinoma patients. Importantly, these symptom differences did not significantly impact health-related and overall QoL. These findings emphasize the nuanced interplay between symptomatology and QoL in different HNC cancer localizations. Conclusion: The research highlights significant disparities in post-treatment symptoms across different HNC localizations and underscores the need for personalized treatment and management strategies to address unique challenges associated with each HNC type, ultimately aiming to enhance post-treatment QoL.

Hospital Palliative Care Team Involvement in Inpatients with Hematologic Malignancies: A Retrospective Study.

Background: Data on the involvement of hospital palliative care teams (HPCT) in the management of patients with hematologic malignancies (HM) are limited. Objectives: To describe characteristics, symptom burden according to the German Hospice and Palliative Care Evaluation assessment tool, and course of inpatients with HM who were referred to a HPCT, and compare them with their counterparts with solid tumors (ST). Design: Retrospective analysis. Setting/Subjects: Inpatients with HM and ST who were referred to the HPCT of a comprehensive cancer center in Germany between January 1, 2015, and December 31, 2019. Results: The analysis included 2885 patients; 412 (14.3%) had HM and 2473 (85.7%) had ST. Patients with HM more often experienced depression (p = 0.003), tension (p < 0.001), and disorientation (p = 0.003); pain (p = 0.029), nausea (p = 0.003), weakness (p < 0.001), loss of appetite (p = 0.005), tiredness (p < 0.001), and need for assistance with activities of daily living (p < 0.001) were more common in patients with ST. Patients with HM were more often admitted to the intensive care unit (ICU) (p < 0.001), had longer ICU stays (p = 0.005), and had a higher death rate (p < 0.001) during their last stay in the hospital. The time between the first contact with the HPCT and death was shorter for patients with HM (p < 0.001). Patients with HM also had a shorter overall time of care by the HPCT (p < 0.001). Conclusions: As compared with their counterparts with ST, inpatients with HM were closer to death at referral to the HPCT, experienced a comparable overall symptom burden, and were admitted to the ICU more frequently after HPCT involvement.

Longitudinal characterization of symptoms, healthcare resource utilization, and costs among people with thrombotic thrombocytopenic purpura compared with non-thrombotic thrombocytopenic purpura controls.

AIMS: Thrombotic thrombocytopenic purpura (TTP) is an ultra-rare blood disorder, characterized by severe ADAMTS13 deficiency. Affected individuals present with potentially life-threatening acute events and may experience sub-acute and chronic TTP manifestations often resulting in long-term organ damage. Incremental symptom prevalence before, during, and after an acute event as well as healthcare resource utilization (HCRU) and costs during and after an acute event were compared between people with TTP and matched non-TTP controls. METHODS: This retrospective, matched study used data from Merative MarketScan Commercial Database and Medicare Supplemental Database (from January 1, 2008, through September 30, 2021) to identify people with TTP (inpatient diagnosis for "thrombotic microangiopathy (TMA)" or "congenital TTP," and ≥1 claim for plasma exchange or infusion). People with TTP were matched (1:2) with non-TTP controls on age, sex, geographic region, index year, and select Elixhauser comorbidities. RESULTS: 255 people with TTP were matched with 510 non-TTP controls. Both cohorts had a mean age of 43.9 years; 71% were female. Overall, more people with TTP reported symptoms compared with non-TTP controls prior to (51% vs 43%), during (99% vs 52%), and after an acute event (85% vs 50%; p < 0.05 for all periods). Symptom prevalence decreased following an acute event compared with during an acute event, but remained high-85% of people with TTP experienced symptoms compared with 50% of non-TTP controls. HCRU and mean costs per patient per month were significantly higher in all care settings among people with TTP compared with non-TTP controls (p < 0.05). LIMITATIONS: Identification of patient populations may have been limited due to coding errors, as the data were obtained from an administrative claims database. CONCLUSIONS: TTP is associated with a substantial symptom burden and increased costs and HCRU during and up to almost a year after acute events, demonstrating the longitudinal burden of this disease.

The impact of elexacaftor/tezacaftor/ivacaftor on cystic fibrosis health-related quality of life and decision-making about daily treatment regimens: a mixed methods exploratory study.

Background: Elexacaftor/tezacaftor/ivacaftor (ETI) has reduced many symptoms of cystic fibrosis (CF). Objectives: We sought to identify the impact of ETI on both symptoms and treatment decisions among adults with CF. Design: Participants were enrolled in a cross-sectional study. Surveys were sent via a RedCap link. Semistructured interviews were administered remotely via Microsoft Teams. Interviews were audio recorded and professionally transcribed. Methods: We assessed Cystic Fibrosis Questionnaire-Revised (CFQ-R) subscales for physical, respiratory, emotion, and treatment, and analyzed semistructured interviews covering CF treatment regimens and daily living. Quantitative and qualitative results were analyzed separately and via a mixed-methods convergence coding matrix. Results: Twenty-four adults with CF taking ETI were included. CFQ-R subscale scores (mean scores/standard deviation) were physical (82.1/22.8), respiratory (83.7/11.2), emotion (65.3/14.2), and treatment (57.5/20.1). Three themes about decision-making for non-ETI-treatments emerged: (1) How I'm feeling, (2) Not noticing a difference, and (3) Uncertainty about long-term impact of modifying treatment regimens, and we found participants weighed each of these factors in their treatment decisions. Key findings from mixed-methods analysis show that among individuals experiencing higher CFQ-R scores for physical and respiratory compared to emotion and treatment, there were statements indicating that while those participants were experiencing better physical health, many continued their burdensome treatment regimens. Conclusion: With little long-term data on the impact of reducing non-ETI treatments, participants weighed how they were feeling, treatment efficacy beliefs, and risk tolerance when making treatment decisions.

The impact of Trikafta on CF health, health-related quality of life, and treatment adherence People with cystic fibrosis may be experiencing many health benefits from taking Trikafta, leading some people to cut back on or stop their other non-Trikafta treatments. We explored the impact of Trikafta on CF health, health-related quality of life, and treatment adherence for people with CF currently taking Trikafta. We compared health-related quality of life subscales from the CF Questionnaire-Revised questionnaire focused on physical symptoms, respiratory symptoms, treatment burden, and emotional well-being to assess whether people with CF were experiencing improved physical and respiratory health compared to emotional health and feelings of treatment burden. We found that many people were feeling better physically, but were still experiencing poor mental health and high treatment burden. We then looked at results from open-ended interviews to see if our qualitative data could explain the differences in the health-related quality of life scores. We found that while people were feeling better physically, many people were still continuing with the pre-Trikafta treatment regimens which may explain why physical health and respiratory health scores were higher than emotional well-being and treatment burden scores. At this time, we believe that more research is needed to guide treatment decisions related to cutting back or stopping burdensome treatment regimens.

A systematic review of symptoms experienced by children and young people with kidney failure.

BACKGROUND: Kidney failure at any age has a significant impact on quality of life (QoL) but the overall symptom burden for children and young people (CYP) is poorly described. Kidney failure has no cure and whilst transplantation is the preferred management option, it is not always possible, with patients requiring supportive care at the end of their lives. AIM: To use the literature to understand the symptom burden for CYP with kidney failure who are approaching end-of-life. METHODS: Using three databases, a systematic literature review was performed to identify eligible studies to extract data on symptoms experienced in CYP aged < 21 years with kidney failure. Data extraction was completed by two authors using a pre-designed proforma. Study quality assessment was undertaken using the BMJ AXIS tool. RESULTS: A total of 20,003 titles were screened to yielding 35 eligible studies including 2,862 CYP with chronic kidney disease (CKD), of whom 1,624 (57%) had CKD stage 5. The studies included a median of 30 (range 7-241) patients. Symptoms were subcategorised into eight groups: sleep, mental health, gastrointestinal, dermatology, ear, nose and throat (ENT), neurology, multiple symptoms, and ophthalmology. The prevalences of the most commonly reported symptoms were: restless leg syndrome 16.7-45%, sleep disordered breathing 20-46%, hypersomnia 14.3-60%, depression 12.5-67%, anxiety 5.3-34%, overall gastrointestinal symptoms 43-82.6%, nausea and vomiting 15.8-68.4%, abdominal pain 10.5-67.4%, altered appetite or anorexia 19-90%, xerosis 53.5-100%, pruritis 18.6-69%, headache 24-76.2% and ophthalmological symptoms 26%. Within each subgroup, the symptom definitions used were heterogeneous, the methods of assessment were varied and some symptoms, such as pain and constipation, were poorly represented. CONCLUSIONS: There is a marked lack of evidence relating to the symptom burden for CYP with CKD. This study highlights the high symptom prevalence, particularly in relation to sleep, mental health, headache, dermatological and gastrointestinal symptoms. There is a need for consensus recommendations on the evaluation and management of symptoms for CYP with CKD approaching end-of-life. PROSPERO ID: CRD42022346120.

Correlates of symptom burden in renal dialysis patients: a systematic review and meta-analysis.

BACKGROUND: Patients receiving renal dialysis often experience a wide range of symptoms. These symptoms contribute to a significant symptom burden that significantly affects patients' quality of life and serves as a significant predictor of healthcare resource utilization and patient prognosis. It is necessary to synthesize existing evidence to draw reliable conclusions to deepen the understanding of symptom burden. OBJECTIVE: A systematic review and meta-analysis were conducted to identify the relevant factors of symptom burden in patients receiving renal dialysis. METHODS: The systematic review and meta-analysis was conducted by searching nine databases for studies reporting the correlates between symptom burden and demographic variables, disease factors, and psychosocial factors from inception to 24 June 2024. After two researchers independently conducted literature search, data extraction, and quality evaluation, meta-analysis was conducted using R Language and Stata 15.1 Software. This study has been registered in the PROSPERO. RESULTS: Sixty-two studies were included in this review. Results showed that the symptom burden of renal dialysis patients was positively correlated with age, gender, working status, medical cost, dialysis age, quality of sleep, nutritional status, comorbidities, depression, anxiety, disease uncertain, avoidance coping and resignation coping, and negatively correlated with marital status, income, serum sodium, quality of life, social support, subjective well-being, and self-management ability. CONCLUSIONS: Our findings reveal that many factors, including demographic, disease-related, and psychosocial variables, affect symptom burden. The results can supply information for health promotion and relief symptom burden for patients receiving renal dialysis.Registered number: CRD42024507577.

Symptom burden, palliative care knowledge, and palliative care needs in advanced gynecological cancer patients in Korea.

Advanced gynecological cancer patients endure numerous symptoms resulting from both the disease itself and the treatments they undergo. This symptom burden significantly impacts the quality of life for both patients and their caregivers, as well as escalating medical costs. Palliative care presents a solution to alleviate these challenges. However, in Korea, there exists a low level of awareness regarding palliative care and consequently, a low utilization rate. Providing timely palliative care to advanced gynecological cancer patients in Korea necessitates a comprehensive understanding of their symptom burden, palliative care knowledge, and palliative care needs. However, no previous studies have addressed this critical issue. The purpose of this study is to determine the impact of advanced gynecological cancer on palliative care needs in Korea according to patient demographic and clinical characteristics, symptom burden, and palliative care knowledge. This study was a descriptive cross-sectional study of data from 115 participants with stage III or IV gynecological cancer, collected through an online questionnaire. The main variables were symptom burden (Functional Assessment of Cancer Therapy-General), palliative care knowledge (Palliative Care Knowledge Scale), and palliative care needs (Problems and Needs in Palliative Care questionnaire-short version). Multiple hierarchical regression analyses were used to determine the relationships between variables. Palliative care needs were divided into perceived problems and requests for professional support. The most common perceived problems were financial problems, psychological issues, and physical symptoms, and the most frequent requests for professional support were financial problems, psychological issues, and the need for information. The perceived problem score increased with age, not having surgical experience, and significant symptom burden. Additionally, the requests for professional support score rose in cases of ovarian cancer, not having surgical history, substantial symptom burden, and limited palliative care knowledge. Advanced gynecological cancer patients have palliative care needs that differ according to patient characteristics, symptom burden, and palliative care knowledge. Identifying factors influencing palliative care needs can aid clinicians in identifying target groups in need of palliative care and providing them with professional palliative care.

Moving beyond "Better Late than Never": High Symptom Burden and Diminished Functional Status at First Palliative Care Visit for Patients with Gynecological Cancers.

Background: Despite physical and emotional distress in patients with gynecologic malignancies, palliative care (PC) is underutilized. Objectives: We characterize referral practices, symptom burden and functional status at the time of initial PC encounter for patients with gynecologic cancer. Design: Data were extracted from the standardized Quality Data Collection Tool for Palliative Care (QDACT-PC). We describe symptom burden and performance status. Results: At initial specialty PC encounter, patients with gynecologic cancers reported a mean of 3.3 moderate/severe symptoms. Outpatients experienced the most moderate/severe symptoms (mean 3.9) versus inpatient (mean 2.1) or home (mean 1.5). A total of 72.7% of patients had significantly impaired functional status (palliative performance scale [PPS] <70) at initial encounter. Inpatients had a more impaired functional status (mean PPS 48.8) than outpatients (mean PPS 67.0). Conclusions: The symptom burden for gynecologic cancer patients at initial PC encounter is high. Despite better functional status, patients referred in the outpatient setting had the highest symptom burden.

Subgroups of ICU patients identified by self-reported symptoms - A prospective multicenter study.

BACKGROUND: Intensive care unit (ICU) patients experience several symptoms, yet patterns of symptoms and their relationship with demographic and clinical characteristics have not previously been investigated. OBJECTIVES: To identify and compare subgroups (i.e. latent symptom classes) of intensive ICU patients based on prevalence of co-occurring symptoms over seven days. RESEARCH METHODOLOGY: Prospective cohort study of adult ICU patients' self-reports of five symptoms during seven days in ICU. Latent class analysis was applied to identify subgroups of ICU patients. SETTING: Multicenter study with patients from six mixed ICUs in Norway. MAIN OUTCOME MEASURES: Patient Symptom Survey was used to assess five symptoms (i.e., thirst, pain, anxiousness, tiredness, shortness of breath). RESULTS: Among 353 included patients, median age was 63 years and 60.3 % were male. Subgroups of patients were identified in a Low class (n = 126, 35.7 %), Middle Class (n = 177, 50.1 %) and High Class (n = 50, 14.2 %) based on reporting of the prevalence of five symptoms. Patients in the Low class had a low prevalence of all symptoms. Middle Class patients had a high prevalence of thirst and tiredness and a low prevalence of pain, anxiousness and shortness of breath. The High class patients had a high prevalence of all symptoms. Symptom prevalence remained stable in the Low and Middle class over time and increased over time in the High class. There were significant differences among symptom classes in use of mechanical ventilation (p = 0.012), analgesics (p < 0.001), alpha-2 agonists (p = 0.004) and fluid restriction (p = 0.006). Patients in the High class received more of these ICU-treatments. CONCLUSIONS: Findings suggest that subgroups of ICU patients with distinct symptom experiences can be identified. The High prevalence class patients had consistently high levels of all symptoms across seven ICU days and received more ICU-related interventions. IMPLICATION FOR CLINICAL PRACTICE: Some ICU patients experience a consistently high prevalence of co-occurring symptoms. Clinicians should be aware of treatment factors that could be linked to a high burden of symptoms.

Precision Health Symptom Science in Oncology Nursing.

Precision health is an emerging approach to predicting, preventing, treating, and managing disease. A goal of precision health symptom science research is the reliable prediction of patients' symptom burden to optimize robu.

Development of a Vitamin B12 Deficiency Patient-Reported Outcome Measure for Clinical Practice and Research.

BACKGROUND: It is difficult to recognize vitamin B12 deficiency and to evaluate the effect of B12 treatment due to a broad range of variable clinical symptoms overlapping with other diseases and diagnostic biomarkers that quickly normalize during treatment. This poses a risk of delay in diagnosis and a challenge to uniformly monitor the effect of B12 treatment. There is a need for a new clinical outcome measure suitable for clinical practice and clinical evaluation studies. OBJECTIVE: To develop a Patient-Reported Outcome Measure (PROM) which measures the severity of vitamin B12 deficiency symptoms. METHODS: The B12 PROM was developed by (1) gathering input from experts and literature review to define a construct and develop a conceptual model, (2) processing input from health care providers, scientists, and patients to develop items and response options, and (3) improving items based on the feedback from laypersons, test interviews, semi-structured cognitive interviews with patients, and forward and backward translation (ENG-NL). RESULTS: The B12 PROM includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Cognitive interviews demonstrated good comprehensibility and comprehensiveness. CONCLUSIONS: This study is the first step in the development of a disease-specific PROM for vitamin B12 deficiency to measure the burden of symptoms. Further validation and reliability testing are necessary before the PROM can be applied in clinical practice and research.

Plain language titleDevelopment of a Vitamin B12 Deficiency Questionnaire for Clinical Practice and ResearchPlain language summaryThis study is the first step in the development of a questionnaire for vitamin B12 deficiency to measure the severity of vitamin B12 deficiency symptoms. The questionnaire includes 62 items grouped into 8 categories of symptoms related to vitamin B12 deficiency (General, Senses, Thinking, In limbs and/or face, Movement, Emotions, Mouth & Abdomen, Urinary tract & Reproductive organs). Interviews with patients demonstrated good comprehensibility and comprehensiveness of the questionnaire. Further testing is necessary before the questionnaire can be applied in clinical practice and research.

Patient-reported symptom burden and circulating cytokines undergoing chemotherapy: a pilot study in patients with ovarian cancer.

OBJECTIVE: To analyze the fluctuations of patient-reported outcomes (PROs) and their relationships with cytokines in the peripheral blood of patients undergoing chemotherapy for ovarian cancer (OC). METHODS: PROs burden was prospectively measured by the M.D. Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) at baseline before chemotherapy, on a daily basis during and post-chemotherapy days (PCD) 7, 14, and 20. Cytokines were collected at baseline, days prior to hospital discharge and PCD 20. Pearson correlation was used to explore the associations between PROs and cytokines levels in peripheral blood. RESULTS: The top 8 rated symptoms were compared between the neoadjuvant chemotherapy (NACT) group (n=20) and the postoperative adjuvant chemotherapy (PAC) group (n=7). Before chemotherapy, the mean scores of fatigue and lack of appetite in the NACT group were higher than those in the PAC group. After chemotherapy, pain, nausea, vomiting, disturbed sleep, lack of appetite, and constipation increased to peak during PCD 2-6; while, fatigue and numbness or tingling remained at high levels over PCD 2-13. By PCD 20, disturbed sleep and fatigue showed a significant increase in mean scores, particularly in the NACT group; while, other symptom scores decreased and returned to baseline levels. Additionally, the longitudinal fluctuations in pain, fatigue, and lack of appetite were positively associated with circulating levels of interleukin-6 and interferon gamma (p<0.05). CONCLUSION: MDASI-OC was feasible and adaptable for demonstrating the fluctuations of symptom burden throughout chemotherapy course. Moreover, symptoms changing along with cytokines levels could provide clues for exploring mechanism underlying biochemical etiology.

The Mediating Effect of Symptom Burden in the Depression and Quality of Life in Patients with Maintenance Hemodialysis.

Objective: To investigate current status of quality of life and the association between depression and symptom burden in a sample of Chinese maintenance hemodialysis (MHD) patients. Methods: A self-designed patient general information questionnaire, disease-related information questionnaire, dialysis patient symptom burden scale, depression scale, and quality of survival scale were used to investigate 380 maintenance haemodialysis patients in haemodialysis centres. A regression model of the factors affecting the quality of survival was established using structural equation modelling. Results: The regression model data had a high goodness of fit: c2/df = 4.736, RMSEA = 0.099, GFI = 0.918, CFI = 0.972, TLI = 0.962, SRMR = 0.0469. Structural equation model analysis showed that depression had a positive predictive effect on symptom burden, ß = 0.398, P < 0.001; Symptom burden had a negative predictive effect on the quality of life, ß =-0.851, P < 0.001; and Depression had a negative predictive effect on the quality of life, ß =-0.151, P < 0.001. Depression indirectly affects the quality of life through symptom burdens. Conclusion: Depression and symptom burden directly or indirectly affect the quality of life in patients with maintenance hemodialysis. Symptom burden moderates the relationship between depression and quality of life as a mediating variable.

The faces of Long-COVID: interplay of symptom burden with socioeconomic, behavioral and healthcare factors.

AIMS: The long-term effects of COVID-19 (Long COVID) include 19 symptoms ranging from mild to debilitating. We examined multidimensional correlates of Long COVID symptom burden. METHODS: This study focused on participants who reported having had COVID in Spring 2023 (n = 656; 85% female, mean age = 55, 59% college). Participants were categorized into symptom-burden groups using Latent Profile Analysis of 19 Long-COVID symptoms. Measures included demographics; quality of life and well-being (QOL); and COVID-specific stressors. Bivariate and multivariate associations of symptom burden were examined. RESULTS: A three-profile solution reflected low, medium, and high symptom burden, aligning with diagnosis confirmation and treatment by a healthcare provider. Higher symptom burden was associated with reporting more comorbidities; being unmarried, difficulty paying bills, being disabled from work, not having a college degree, younger age, higher body mass index, having had COVID multiple times, worse reported QOL, greater reported financial hardship and worry; maladaptive coping, and worse healthcare disruption, health/healthcare stress, racial-inequity stress, family-relationship problems, and social support. Multivariate modeling revealed that financial hardship, worry, risk-taking, comorbidities, health/healthcare stress, and younger age were risk factors for higher symptom burden, whereas social support and reducing substance use were protective factors. CONCLUSIONS: Long-COVID symptom burden is associated with substantial, modifiable social and behavioral factors. Most notably, financial hardship was associated with more than three times the risk of high versus low Long-COVID symptom burden. These findings suggest the need for multi-pronged support in the absence of a cure, such as symptom palliation, telehealth, social services, and psychosocial support.

Characterizing the Physical and Psychological Experiences of Newly Diagnosed Pancreatic Cancer Patients.

BACKGROUND: Pancreatic cancer is a devastating disease with a poor prognosis, causing significant physical and psychological distress that detrimentally impacts patients' quality of life. AIM: This study aimed to comprehensively assess the physical and psychological status of newly diagnosed pancreatic cancer patients. METHODS: A cohort of 138 newly diagnosed patients completed standardized assessments, including the Edmonton Symptom Assessment System (ESAS), Patient Health Questionnaire-9 (PHQ-9), Mini-Mental State Examination (MMSE), and Distress Thermometer (DT). Data were analysed using descriptive statistics. RESULTS: The ESAS scores revealed high symptom burden, with mean scores of 6.8 for pain, 7.2 for fatigue, and 4.9 for depression. Measures of well-being indicated low scores, with means of 2.3 for physical well-being, 1.5 for social/family well-being, and 1.7 for emotional well-being. Distress levels were also high, with a mean score of 7.6 on the DT. CONCLUSION: Newly diagnosed pancreatic cancer patients experience substantial physical and psychological challenges, including severe symptom burden, distress, depressive symptoms, and cognitive impairment. Holistic care approaches that prioritize symptom management and address psychological distress are essential to improve patient outcomes and enhance overall well-being.