Assessment Of Chronic Illness Therapy Research Articles

#1353 Apathy and fatigue in patients treated with haemodialysis and peritoneal dialysis

Abstract Background and Aims Apathy is a distinct syndrome manifesting with a loss of interest in social or emotional situations, lack of sense of purpose, low energy levels and detachment from life and personal events. Previous studies showed that apathy is associated with vascular impairment and consequent cognitive dysfunction, reduced quality of life and increased hospitalization, institutionalization, healthcare costs and death. So far there has been little research on the prevalence of apathy among dialysis patients although this population could be considered at risk for this condition due to increasing age, and disease and treatment burden. Fatigue is also common in dialyzed patients and impacts daily living, impairs the quality of life, increases the risk of cardiovascular events and negatively influences survival. This study aimed to explore the link between apathy and fatigue among hemodialysis (HD) and peritoneal dialysis (PD) patients. Method We conducted a cross-sectional cohort study which included 75 HD (57.3% male, median age 64 years) and 62 PD patients (48.4% male, median age 61 years) from two dialysis centres. Apathy status was assessed by the Apathy Evaluation Scale (AES) by Starkstein. Fatigue was evaluated with the Functional Assessment of Chronic Illness Therapy (FACIT) scale. AES score of 14 and higher denotes the presence of apathy, while a FACIT score of less than 30 indicates severe fatigue. Demographic, clinical and laboratory data were obtained by a focused questionnaire and from electronic medical records. Data were analyzed with T-test, Hi-square, ANOVA and Pearson correlation as applicable. Results HD patients were significantly longer on dialysis than PD patients (p=0.046). Apathy was more frequent among PD patients compared to the HD group (64.5% vs 48%), but the difference was not statistically significant (p = 0.053). Severe fatigue was more frequent in the HD group (33.8% vs 27.4%), but the difference was not statistically significant (p = 0.424). Elderly patients had a higher prevalence of apathy in both HD (70.3% vs 29.7%, p<0.001) and PD groups (84.2% vs 16.3%, p = 0.008), and a significantly higher prevalence of severe fatigue in the HD group (68% vs 32%, p = 0.017). Among HD patients higher education level was significantly associated with higher FACIT and lower apathy scores (p = 0.002 and p = 0.001 respectively). HD patients taking psychotropic medication had significantly lower FACIT (27.2±13.5 vs 35.0 ± 11.9, p = 0.03). Also, the presence of apathy was significantly associated with lower hemoglobin levels (101.7±9.7 vs 110.3±11.2, p = 0.001), red blood cells count (3.2±0.2 vs 3.5±0.6, p = 0.004), lower serum creatinine (900.0±149.1 vs 1001.5±266.4, p = 0.047) and lower Kt/V (1.35±0.22 vs 1.49±0.24, p = 0.008) in the HD group, while PD patients with severe fatigue had significantly higher creatinine levels (796.7±176.9 vs 646.4±200.0, p = 0.009). Gender, dialysis vintage, primary renal disease, and comorbidities were not significantly associated with either apathy or fatigue in either group of patients. Apathy and fatigue were significantly correlated in both the HD (p = 0.04) and the PD (p = 0.001) groups. Conclusion Apathy is a highly prevalent and often overlooked condition among dialyzed patients regardless of dialysis modality. Longitudinal studies should explore whether apathy is a causative factor for fatigue in these populations.

The effect of social support on the emotional well-being of people with amyotrophic lateral sclerosis: Exploring the mediating role of spirituality.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that, so far, is considered always fatal. Treatments mainly consist in increasing survival and aim to improve the quality of life of people with ALS (pwALS). Social support and spirituality have been shown to play a key role in pwALS' quality of life. Our study explored it in depth by investigating the underlying mechanisms linking social support, spirituality, and emotional well-being. Thirty-six pwALS underwent a battery of tests evaluating emotional well-being (emotional well-being scale of the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire), social support (6-item Social Support Questionnaire), and spiritual well-being (12-item Functional Assessment of Chronic Illness Therapy - Spiritual well-being). Our recruitment was web-based through the FILSLAN and the ARSLA websites as well as through Facebook® advertisements (ALS groups). Data were analyzed by Pearson correlation analysis and Process macro was used in an SPSS program to analyze the mediator variable effect. Availability of social support, spiritual well-being, and 2 of its dimensions, i.e., meaning and peace, were positively correlated with emotional well-being. The mediational analyses showed that spiritual well-being, meaning, and peace act as mediators in the association between availability of social support and good emotional well-being. Availability of social support and spirituality are essential for the emotional well-being of pwALS. Spirituality as a mediator between availability of social support and emotional well-being appears as real novel finding which could be explored further. Spiritual well-being, meaning, and peace appear as coping resources for pwALS. We provide practical guidance for professionals working with pwALS.

Normalization of Hemoglobin, Lactate Dehydrogenase, and Fatigue in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Pegcetacoplan.

We determined normalization rates for hemoglobin, lactate dehydrogenase (LDH), and fatigue in patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with pegcetacoplan (PEG) in the PEGASUS (NCT03500549) and PRINCE (NCT04085601) phase III trials. Enrolled patients had PNH and hemoglobin <10.5 g/dL despite ≥3 months of eculizumab (ECU) [PEGASUS], or were complement component 5 (C5) inhibitor-naive, receiving supportive care only, with hemoglobin less than the lower limits of normal (LLN) [PRINCE]. Hematologic and fatigue normalization endpoints were hemoglobin greater than or equal to the LLN (females: 12 g/dL; males: 13.6 g/dL) in the absence of transfusion; LDH ≤226U/L in the absence of transfusion; and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue ≥43.6, the general population norm. Safety was assessed by investigators using standardized terms and definitions for seriousness and severity. Hemoglobin normalization occurred in 34.1% (14/41) of PEG-treated patients at Week 16 (randomized controlled period) in PEGASUS (vs. 0% [0/39] of ECU-treated patients) and in 45.7% (16/35) of PEG-treated patients at Week 26 in PRINCE (vs. 0% [0/18] of supportive care-treated patients). At Week 48 (open-label period) in PEGASUS, 24.4% of PEG-treated patients (PEG-to-PEG) and 30.8% of patients treated with ECU through Week 16 who switched to PEG through Week 48 (ECU-to-PEG) had hemoglobin normalization. Rates of LDH normalization in PEGASUS were 70.7% (PEG-treated patients) and 15.4% (ECU-treated patients) at Week 16, and 56.1% (PEG-to-PEG) and 51.3% (ECU-to-PEG) at Week 48. In PRINCE, 67.5% of PEG-treated patients at Week 26 had normalized LDH concentrations. Rates of FACIT-Fatigue score normalization in PEGASUS were 48.8% and 10.3% in PEG- and ECU-treated patients, respectively, at Week 16, and 34.1% and 51.3% in PEG-to-PEG- and ECU-to-PEG-treated patients, respectively, at Week 48. In PRINCE, 68.6% of PEG-treated patients and 11.1% of supportive care patients had FACIT-Fatigue score normalization at Week 26. PEG was safe and well tolerated. Injection site reactions, mostly mild, were the most common adverse event of special interest in PEG-treated patients in the PEGASUS randomized controlled period (36.6%) and in PRINCE (30.4%). PEG is superior to ECU and supportive care in hemoglobin, LDH, and FACIT-Fatigue score normalization for patients with PNH and persistent anemia despite ≥3 months of treatment with ECU, and in C5 inhibitor-naive patients. The PEGASUS trial (NCT03500549) was registered on 18 August 2018, and the PRINCE trial (NCT04085601) was registered on 11 September 2019.

Exploring the nexus between fatigue, body composition, and muscle strength in hemodialysis patients

BackgroundFatigue is a relatively prevalent condition among hemodialysis patients, resulting in diminished health-related quality of life and decreased survival rates. The purpose of this study was to investigate the relationship between fatigue and body composition in hemodialysis patients.MethodsThis cross-sectional study included 92 patients in total. Fatigue was measured by Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) (cut-off ≤ 34). Body composition was measured based on quantitative computed tomography (QCT), parameters including skeletal muscle index (SMI), intermuscular adipose tissue (IMAT), and bone mineral density (BMD). Handgrip strength was also collected. To explore the relationship between fatigue and body composition parameters, we conducted correlation analyses and binary logistic regression.ResultsThe prevalence of fatigue was 37% (n = 34), abnormal bone density was 43.4% (n = 40). There was a positive correlation between handgrip strength and FACIT-F score (r = 0.448, p < 0.001). Age (r = − 0.411, p < 0.001), IMAT % (r = − 0.424, p < 0.001), negatively associated with FACIT-F score. Multivariate logistic regression analysis shows that older age, lower serum phosphorus, higher IMAT% are associated with a high risk of fatigue.ConclusionThe significantly increased incidence and degree of fatigue in hemodialysis patients is associated with more intermuscular adipose tissue in paraspinal muscle.

Advance Care Planning for Children With Rare Diseases: A Pilot RCT.

Pediatric rare diseases are often life-limiting conditions and/or require constant caregiving. Investigators assessed the initial efficacy of the FAmily CEntered (FACE) pediatric advance care planning (pACP), FACE-Rare, intervention on families' quality of life. A pilot-phase, single-blinded, intent-to-treat, randomized controlled clinical trial enrolled families from 1 pediatric quaternary hospital between 2021 and 2023. Intervention families received 3 weekly 60-minute (FACE-Rare pACP) sessions: (1) Carer Support Needs Assessment Tool or Action Plan, (2) Carer Support Needs Assessment Tol Action Plan Review, and (3) Pediatric Next Steps: Respecting Choices pACP. Controls received treatment as usual (TAU). Outcome measures were Beck Anxiety Inventory, Family Appraisal of Caregiving, Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality, and health care utilization. Generalized mixed effect models with γ response assessed the intervention effect at 3-month follow-up. Children (n = 21) were aged 1 to 10 years, 48% male, 24% Black; and 100% technology dependent. Primary family caregivers (n = 21) were aged 30 to 43 years, 19% male, 19% Black; and 27% household income below the Federal poverty level. Dyads underwent 1:1 randomization: 9 to FACE-Rare and 12 to TAU. TAU caregivers reported statistically lower meaning and peace than FACE-Rare caregivers (0.9, P = .03, confidence interval [CI]: 0.75-0.99). Black caregivers reported significantly less caregiver distress (0.7, P = .04, CI: 0.47-0.98) than non-Black caregivers. Poor families reported more anxiety (3.5, P = .002, CI: 1.62-7.94), more caregiver strain (1.2, P = .006, CI: 1.07-1.42); and less family well-being (0.8, P = .02, CI: 0.64-0.95). FACE®-Rare was feasible, acceptable, safe, and demonstrated initial efficacy, providing greater feelings of meaning and peace to caregivers. Poverty impacted well-being. A multisite trial is needed to determine generalizability.

Psychometric analysis of the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) in a prospective multicentre study

BackgroundLong COVID (LC) is a novel multisystem clinical syndrome affecting millions of individuals worldwide. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) is a condition-specific patient-reported outcome measure designed for assessment...

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Cancer-related fatigue and activities of daily living: lessons learned from the COVID-19 pandemic

BackgroundCancer-related fatigue is a prevalent condition in all stages of oncologic disease that is poorly diagnosed, with a negative impact on physical function to perform activities of daily living. Fatigue is also one of the main manifestations in post-COVID-19 syndrome, and few studies have explored the functionality of cancer patients after infection by the new coronavirus. This study was designed to assess cancer-related fatigue symptoms and their implications on physical function and quality of life during the pandemic.MethodologyAn observational study with a cross-sectional survey in cancer patients ≥ 18 years of age was conducted. The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F), the perception of asthenia and performance status were evaluated, and the differences between groups according to the history of COVID-19 were calculated.ResultsA total of 60 cancer patients had an average age of 33.5 ± 10.11 years, 73.3% were female, and 98.3% had an Eastern Cooperative Oncology Group-Performance Status level < 2. Severe fatigue was found in 43.3% of patients, and the average FACIT-F score was 33.5 ± 10.11. The proportion of coronavirus infection was 13,3%, and the performance of this group was worse on the scale compared to the group without infection (25 ± 10,40 vs. 34,81 ± 9,50 [p = 0,009]). There was a significant correlation between visual analog scale values and FACIT-F scale scores (Pearson’s r = -0.76).ConclusionSARS-CoV-2 infection could increase cancer-related fatigue symptoms, limiting activities of daily living and impairing quality of life.

P168 The impact of psoriatic arthritis on quality of life and lifestyle: a systematic review

Abstract Background/Aims Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects adults of all ages. It is common for patients to experience a wide variety of physical and psychological problems. The objective of this systematic review was to determine how PsA impacts a person's quality of life (QoL). Methods A systematic literature search of CENTRAL, CINAHL, AMED, EMBASE, Global Health, MEDLINE and PsycINFO databases was conducted on 28th May 2021. Title, abstract and whole text screening, and data extraction were completed by two independent authors. The primary outcomes of this study were PsA activity and severity, impact of PsA on lifestyle and QoL. As per the protocol (PROSPERO CRD42021257395), studies which reported at least one of these primary outcomes were included. The quality assessment was conducted using the Joanna Briggs Institute Critical Appraisal criteria. Results Of the 20,316 papers identified by the search strategy, 42 papers which reported on at least one of the study primary outcomes were included in the review. 38 studies reported on PsA activity and severity, 26 on impact of PsA on lifestyle and 23 on QoL. 7 different measures were used to assess impact of PsA on lifestyle, including Health Assessment Questionnaire (HAQ) (n = 13), modified HAQs (n = 10), PsA impact of disease measure (n = 2), functional capacity ACR (n = 1), functional assessment of chronic illness therapy (n = 1), Bath ankylosing spondylitis functional index (n = 1) and a patient-directed question (n = 1). 13 papers reported an average HAQ score between 0.13 and 1.3 for PsA participants. Two studies which reported HAQ disability index compared PsA participants to other groups. Thus, the impact of disease on lifestyle is worse for PsA compared to psoriasis, rheumatoid arthritis and healthy controls, psoriasis. DAPSA and PASI were the most used disease activity scores in addition to various patient-reported outcomes. The average DAPSA was 15.5, suggesting that the majority of PsA patients have moderate disease activity. Although the average PASI (skin) score showed mild disease among the PsA (3.82) group, a high PASI score was associated with late/never minimal disease activity and obesity. 8 different measures were used to assess QoL, including Psoriatic Arthritis Quality of Life (n = 6, average), EQ-5D (n = 4), EQ-3D (n = 1), DLQI (n = 7), SF-36 (n = 3), SF-12 (n = 1), WHOQOL-BREF (n = 2), PSQI (n = 1), Rosenberg Self-Esteem Scale (n = 1) and Psoriasis disability index (n = 1). Except for QoL for skin (DLQI), PsA was associated with worse outcomes in all these measures, in comparison with spondylarthritis, healthy control and psoriasis only groups. Conclusion PsA significantly affects a patient's life and health-related QoL. The degree of activity and severity of the disease have a substantial impact. Therefore, for patients with high disease activity, specific management plans should be discussed and facilitated to maintain their mobility and functional abilities. Disclosure L. James: None. R. Suribhatla: None. L.H. Hailey: None. R. Amarnani: None. C. Bundy: None. D. McGagh: None. S. Kirtley: None. D. O'Sullivan: None. I. Steinkoenig: None. L.C. Coates: None.

Clinical significance of anti-mutated citrullinated vimentin antibodies in rheumatoid arthritis patients.

Anti-mutated citrullinated vimentin (MCV) antibodies have recently been recommended as a better arthritis diagnostic marker. To investigate the association between anti-MCV antibodies and the clinical, functional, and radiographic characteristics of rheumatoid arthritis (RA) patients. This case-control study was conducted on 40RApatients and 40healthy subjects. All patients were subjected to an assessment of disease using the 28-joint DAS (DAS28) and Clinical Disease Activity Index (CDAI), function by HAQ-DI, physical activity by International Physical Activity Questionnaire (IPAQ), fatigue by Functional Assessment of Chronic Illness Therapy (FACIT), serological tests as well as anti-MCV Abs measurement. A plain X-ray of both hands and wrists was done. The anti-MCV Abs level was significantly higher in RA patients than in healthy controls (P< 0.001). The anti-MCV Abs had a significant positive correlation with DAS, CDAI, HAQ, RF, Anti-CCP, and CRP (P= 0.006, 0.013, 0.005, < 0.001, < 0.001and 0.041respectively) and a significant negative correlation with FACIT (p= 0.007). Positive anti-MCV RA patients had significantly higher erosions, JSN, and a total sharp score. Anti-MCV Abs may contribute to poor physical activity and more fatigue in RA patients beyond their established role in disease activity and erosion.

Safety and Efficacy of Pegcetacoplan in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria over 48Weeks: 307 Open-Label Extension Study.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Pegcetacoplan, the first targeted complement component3 (C3) PNH therapy, was safe and efficacious in treatment-naive and pre-treated patients with PNH in five clinical trials. The 307 open-label extension (OLE) study (NCT03531255) is a non-randomized, multicenter extension study of long-term safety and efficacy of pegcetacoplan in adult patients with PNH who completed a pegcetacoplan parent study. All patients received pegcetacoplan. Outcomes at the 48-week data cutoff (week48 of 307-OLE or August 27, 2021, whichever was earlier) are reported. Hemoglobin concentrations, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores, and transfusion avoidance were measured. Hemoglobin > 12g/dL and sex-specific hemoglobin normalization (i.e., male, ≥ 13.6g/dL; female, ≥ 12g/dL) were assessed as percentage of patients with data available and no transfusions 60days before data cutoff. Treatment-emergent adverse events, including hemolysis, were reported. Data from 137 patients with at least one pegcetacoplan dose at data cutoff were analyzed. Mean (standard deviation [SD]) hemoglobin increased from 8.9 (1.22) g/dL at parent study baseline to 11.6 (2.17) g/dL at 307-OLE entry and 11.6 (1.94) g/dL at data cutoff. At parent study baseline, mean (SD) FACIT-Fatigue score of 34.1 (11.08) was below the general population norm of 43.6; scores improved to 42.8 (8.79) at 307-OLE entry and 42.4 (9.84) at data cutoff. In evaluable patients, hemoglobin > 12g/dL occurred in 40.2% (43 of 107) and sex-specific hemoglobin normalization occurred in 31.8% (34 of 107) at data cutoff. Transfusion was not required for 114 of 137 patients (83.2%). Hemolysis was reported in 23 patients (16.8%). No thrombotic events or meningococcal infections occurred. Pegcetacoplan sustained long-term improvements in hemoglobin concentrations, fatigue reduction, and transfusion burden. Long-term safety findings corroborate the favorable profile established for pegcetacoplan. ClinicalTrials.gov identifier, NCT03531255.

A pilot study to evaluate the feasibility and potential effectiveness of an early palliative care model: "Educate, Nurture, Advise, Before Life Ends for Singapore".

The main objective was to pilot the culturally adapted "Educate, Nurture, Advise, Before Life Ends" for Singapore (ENABLE-SG) model to evaluate its feasibility and potential effectiveness. A single-arm pilot trial of ENABLE-SG among patients with advanced solid tumors and caregivers of these patients was conducted in the outpatient oncology clinic setting. Enrolled participants participated in individual ENABLE-SG psychoeducational sessions weekly. Patients had 6 sessions on the topics of maintaining positivity, self-care, coping with stress, managing symptoms, exploring what matters most and life review. Caregivers had 4 sessions on the topics of maintaining positivity, self-care, coping with stress and managing symptoms. At baseline, 4, 8, and 12 months after enrolment, patient's quality of life was measured using the Functional Assessment of Chronic Illness Therapy - Palliative Care, patient's mood was measured using the Center for Epidemiologic Studies - Depression scale, and caregiver quality of life was measured using the Singapore Caregiver Quality of Life Scale. We enrolled 43 patients and 15 caregivers over a 10-month period from August 2021 to June 2022. Although there was a low approach-to-participation rate, most of those who enrolled completed all ENABLE-SG sessions - 72% for patients and 94% for caregivers. Caregivers had better quality of life over time, specifically in the subscales of mental well-being and experience-meaning. Based on findings from this study, we are planning a randomized waitlist-controlled trial of ENABLE-SG for patients with advanced cancer and their caregivers.

Health related quality of life, physical function, and cognitive performance in mechanically ventilated COVID-19 patients: A long term follow-up study

BackgroundSurvivors of severe COVID-19 related respiratory failure may experience durable functional impairments. We aimed at investigating health-related quality of life (HR-QoL), physical functioning, fatigue, and cognitive outcomes in COVID-19 patients who received invasive mechanical ventilation (IMV). MethodsCase-series, prospective, observational cohort study at 18 months from hospital discharge. Patients referring to the Intensive Care Unit (ICU) of Humanitas Research Hospital (Milan, Italy) were recruited if they needed IMV due to COVID-19 related respiratory failure. After 18 months, these patients underwent the 6-min walking test (6MWT), the Italian version of the 5-level EQ-5D questionnaire (EQ-5D-5L), the Functional Assessment of Chronic Illness Therapy – Fatigue questionnaire (FACIT-F), the Trail Making Test-B (TMT-B) and the Montreal Cognitive Assessment-BLIND test (MoCA-BLIND). Results105 patients were studied. The population's age was 60 ± 10 years on average, with a median Frailty Scale of 2 (Hodgson et al., 2017; Carenzo et al., 2021a [2,3]). EQ-VAS was 80 [70–90] out of 100, walked distance was 406 [331–465] meters, corresponding to about 74 ± 19,1% of the predicted value. FACIT-F score was 43 [36–49] out of 52, and MoCa-BLIND score was 19 (DeSalvo et al., 2006; von Elm et al., 2008; Herdman et al., 2011; Scalone et al., 2015 [16-20]) out of 22. The median TMT-B time was 90 [62–120] seconds. We found a possible age and gender specific effect on HR-QoL and fatigue. ConclusionsAfter 18 months from ICU discharge, survivors of severe COVID-19 respiratory failure experience a moderate reduction in HR-QoL, and a severe reduction in physical functioning. Fatigue prevalence is higher in younger patients and in females. Finally, cognitive impairment was present at a low frequency.

The association of prognostic awareness with quality of life, spiritual well-being, psychological distress, and pain severity in patients with advanced cancer: Results from the APPROACH Study in Indonesia.

Advanced cancer patients' understanding of their illness is key for making informed treatment decisions. Despite the known importance of patients' awareness of their disease prognosis, it is debatable whether this awareness is positively, negatively, or not associated with clinical and psychological outcomes among patients with advanced cancer. This paper aims to determine the prevalence of and factors associated with prognostic awareness and its association with quality of life (QoL), spiritual well-being, pain control, and psychological distress in patients with advanced cancer in Indonesia. This cross-sectional questionnaire-based survey was part of a multicountry study titled "Asian Patient Perspectives Regarding Oncology Awareness, Care and Health (APPROACH)." Patients were asked what they knew about their cancer and treatment. QoL and spiritual well-being were measured using the Functional Assessment of Cancer Therapy - General (FACT-G) and Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) questionnaire. Psychological distress experienced by patients was recorded via the Hospital Anxiety and Depression Scale. Pain severity was also assessed. Data from 160 patients were analyzed using descriptive statistics and multivariable regression models. Of the 160 patients who participated, 55 (34.4%) were unaware of their cancer stage. Those who were aware of their stage of cancer were younger than those who were not aware (45.7 years vs 50.4 years, p = .015). There was no significant difference in spiritual well-being and other domains of QoL between those who were aware and those who were not aware of their advanced cancer stage. There was also no significant difference in anxiety depression or pain severity, even after adjustment for demographic and clinical characteristics. Given the high prevalence of patients who wrongly thought their cancer was curable, more could be done to improve disease and prognostic understanding among patients with advanced cancer in Indonesia. Those who were aware of their advanced cancer stage did not have a poorer QoL, nor did they have more anxiety or depression than those who were unaware. This finding suggests that concerns about the negative impact of prognostic disclosure may be unfounded.

Patient Navigator Intervention to Improve Palliative Care Outcomes for Hispanic Patients With Serious Noncancer Illness

Disparities persist across the trajectory of serious illness, including at the end of life. Patient navigation has been shown to reduce disparities and improve outcomes for underserved populations. To determine the effectiveness of a lay patient navigator intervention, Apoyo con Cariño, in improving palliative care outcomes among Hispanic patients. This was a multicenter randomized clinical trial that took place across academic, nonprofit, safety-net, and community health care systems in urban, rural, and mountain/frontier regions of Colorado from January 2017 to January 2021. Self-identifying Hispanic adults with serious noncancer medical illness and limited prognosis were recruited. Data were collected and analyzed from July 2022 to July 2023. Participants randomized to the intervention group received 5 home visits from a bilingual, bicultural lay patient navigator; participants randomized to control received care as usual. Both groups received culturally tailored educational materials. Investigators/outcome accessors remained blinded to participant assignment. Change in score from baseline to 3 months on the Functional Assessment of Chronic Illness Therapy (FACIT) General quality of life (QOL) scale (primary outcome), Advance Care Planning (ACP) Engagement Survey, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and FACIT Spiritual Well-Being subscale; at 6 months, advance directive (AD) documentation; and at 46 months or death, hospice utilization and length of stay, as well as aggressiveness of care at end of life. Of 209 patients enrolled (mean [SD] age, 63.6 [14.3] years; 108 [51.7%] male), 105 patients were randomized to control and 104 patients to the intervention. There were no statistically significant differences in the change in mean (SD) QOL score between the intervention and control groups (5.0 [16.5] vs 4.3 [15.5]; P = .75). Participants in the intervention group, compared with the control group, had statistically significant greater increases in mean (SD) ACP engagement (0.8 [1.3] vs 0.1 [1.4]; P < .001) and were more likely to have a documented AD (62 of 104 [59.6%] vs 28 of 105 [26.9%]; P < .001). There were no statistically significant differences in mean (SD) change in pain intensity score (0-10) between patients in the intervention group compared with control (-0.4 [2.6] vs -0.5 [2.8]; P = .79), nor pain interference (-0.2 [3.7] vs -0.4 [3.7]; P = .71). Patients receiving the intervention were more likely to be referred to hospice compared with patients receiving control (19 of 43 patients [44.2%] vs 7 of 33 patients [21.2%]; P = .04) and less likely to receive aggressive care at end of life (27 of 42 patients [64.3%] vs 28 of 33 patients [84.8%]; P = .046). In this randomized clinical trial, a culturally tailored patient navigator intervention did not improve QOL for patients. However, the intervention did increase ACP engagement, AD documentation, and hospice utilization in Hispanic persons with serious medical illness. ClinicalTrials.gov Identifier: NCT03181750.

Cross-Cultural Adaptation and Psychometric Properties of The Thai Versions of The Patient-Reported Outcomes Measurement Information System Short Form – Anxiety 8a and the Pain Anxiety Symptoms Scale-20 in Individuals with Chronic Low Back Pain

Objective: To translate and cross-culturally adapt the Patient-Reported Outcomes Measurement Information System Short Form v1.0–Anxiety 8a and the Pain Anxiety Symptoms Scale-20 into Thai versions (T-PROMIS-Anx8a and T-PASS-20, respectively) and evaluate their psychometric properties in individuals with chronic low back pain (CLBP).Material and Methods: The translations and cultural adaptations were performed using the Functional Assessment of Chronic Illness Therapy (FACIT) guidelines. Thai individuals with CLBP completed the T-PROMIS-Anx8a and T-PASS-20. Psychometric evaluation including: internal consistency, test-retest reliability, and dimensionality. Construct validity was evaluated by computing correlations among the scores on the T-PROMIS-Anx8a, T-PASS-20, Thai version of the Hospital Anxiety and Depression Scale–Anxiety (T-HADS-A), and Thai version of the Fear Avoidance Beliefs Questionnaire (T-FABQ).Results: A total of 269 individuals with CLBP were included in the analyses. The T-PROMIS-Anx8a showed unidimensionality and the T-PASS-20 evidenced a 4-factor structure. Both measures demonstrated good to excellent internal consistency (Cronbach’s alphas ranged from 0.85 to 0.95), good test-retest reliability (ICC(2,1) ranged from 0.79 to 0.88), and neither ceiling nor floor effects were observed for any of the scales. Both measures evidenced acceptable convergent and discriminant validity, based on their associations with the T-HADS-A and T-FABQ.Conclusion: The T-PROMIS-Anx8a and T-PASS-20 were culturally adapted and evidenced acceptable psychometric properties for assessing anxiety in Thai individuals with CLBP.

Cross-Cultural Adaptation and Psychometric Properties of The Thai Versions of The Patient-Reported Outcomes Measurement Information System Short Form – Anxiety 8a and the Pain Anxiety Symptoms Scale-20 in Individuals with Chronic Low Back Pain

Objective: To translate and cross-culturally adapt the Patient-Reported Outcomes Measurement Information System Short Form v1.0–Anxiety 8a and the Pain Anxiety Symptoms Scale-20 into Thai versions (T-PROMIS-Anx8a and T-PASS-20, respectively) and evaluate their psychometric properties in individuals with chronic low back pain (CLBP).Material and Methods: The translations and cultural adaptations were performed using the Functional Assessment of Chronic Illness Therapy (FACIT) guidelines. Thai individuals with CLBP completed the T-PROMIS-Anx8a and T-PASS-20. Psychometric evaluation including: internal consistency, test-retest reliability, and dimensionality. Construct validity was evaluated by computing correlations among the scores on the T-PROMIS-Anx8a, T-PASS-20, Thai version of the Hospital Anxiety and Depression Scale–Anxiety (T-HADS-A), and Thai version of the Fear Avoidance Beliefs Questionnaire (T-FABQ).Results: A total of 269 individuals with CLBP were included in the analyses. The T-PROMIS-Anx8a showed unidimensionality and the T-PASS-20 evidenced a 4-factor structure. Both measures demonstrated good to excellent internal consistency (Cronbach’s alphas ranged from 0.85 to 0.95), good test-retest reliability (ICC(2,1) ranged from 0.79 to 0.88), and neither ceiling nor floor effects were observed for any of the scales. Both measures evidenced acceptable convergent and discriminant validity, based on their associations with the T-HADS-A and T-FABQ.Conclusion: The T-PROMIS-Anx8a and T-PASS-20 were culturally adapted and evidenced acceptable psychometric properties for assessing anxiety in Thai individuals with CLBP.

Hematopoietic Stem Cell Transplantation Impact on Patients' Perceived Quality of Life: A Longitudinal Study.

The aim of this paper was to evaluate the quality of life of adult patients with onco-hematological disease treated with hematopoietic stem cell transplantation up to two years post-transplantation. A quantitative, observational, longitudinal, and analytical study was conducted with 121 participants diagnosed with onco-hematological cancer who underwent hematopoietic stem cell transplantation between October 2017 and September 2019, with a 2-year post-transplantation follow-up, of whom only 39 completed the study. The Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) questionnaire and its subscales, Functional Assessment of Cancer Therapy-General (FACT-BMT) and Functional Assessment of Cancer Therapy Trial Outcome Index (FACT-TOI), developed by the Functional Assessment of Chronic Illness Therapy (FACIT) and validated for Spain, were used to assess quality of life. The average age for hematopoietic stem cell transplantation was 54 years, with a majority of male participants. The evaluation of quality of life showed a decrease at the time of hospital discharge, followed by a progressive improvement up to one year after the transplantation. There was a significant difference in the quality of life questionnaire scores between both sexes during all stages of the research, with higher scores in male participants. The length of hospital stay significantly affected patients' physical and functional well-being, and marital status was related to differences in the perception of quality of life. Despite the initial decrease in quality of life for patients undergoing hematopoietic stem cell transplantation, levels of quality of life similar to baseline are regained one year after the transplantation. Sociodemographic variables are related to how these patients perceive their quality of life. However, further studies with a larger sample size are needed for more precise results.

Translation and Cultural Adaptation into Arabic of Patient-Reported Outcome Measurement Information System® Item Banks: Cognitive Function Abilities and Physical Function for Samples with Mobility Aid Users.

This study aimed to provide Arabic-speaking individuals with tools to assess their cognitive abilities and physical function and to contribute to a better understanding of these capabilities in this population. Thus, the specific objective was to translate into Arabic and culturally adapt two Patient-Reported Outcome Measurement Information System (PROMIS) item banks: the Adult Cognitive Function Abilities and the Physical Function for Samples with Mobility Aid Users item banks. This study employed the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation methodology to ensure cultural and linguistic relevance. The translation process included forward and back translations, expert reviews, and finalisation by a language coordinator. Cognitive debriefing interviews were conducted with 30 native healthy Arabic speakers to assess the clarity and comprehension of translated items. Most items were well understood, but two items related to cognitive ability and four related to physical functions required revision to address participant confusion. The translations were refined based on the participants' feedback and expert recommendations. This study followed a rigorous translation process and included cognitive debriefing interviews to ensure linguistic and cultural equivalence. The availability of these tools in Arabic enhances cross-cultural research and practice in healthcare and contributes to a global understanding of cognitive and physical functions.

Health-related quality of life and experience measures, to assess patients’ experiences of peripheral intravenous catheters: a secondary data analysis

BackgroundPeripheral intravenous catheters (PIVCs) are essential for successful administration of intravenous treatments. However, insertion failure and PIVC complications are common and negatively impact patients’ health-outcomes and experiences. We aimed to assess whether generic (not condition-specific) quality of life and experience measures were suitable for assessing outcomes and experiences of patients with PIVCs.MethodsWe undertook a secondary analysis of data collected on three existing instruments within a large randomised controlled trial, conducted at two adult tertiary hospitals in Queensland, Australia. Instruments included the EuroQol Five Dimension - Five Level (EQ5D-5L), the Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – General measure (FACIT-TS-G, eight items), and the Australian Hospital Patient Experience Question Set (AHPEQS, 12 items). Responses were compared against two clinical PIVC outcomes of interest: all-cause failure and multiple insertion attempts. Classic descriptives were reported for ceiling and floor effects. Regression analyses examined validity (discrimination). Standardised response mean and effect size (ES) assessed responsiveness (EQ5D-5L, only).ResultsIn total, 685 participants completed the EQ5D-5L at insertion and 526 at removal. The FACIT-TS-G was completed by 264 and the AHPEQS by 262 participants. Two FACIT-TS-G items and one AHPEQS item demonstrated ceiling effect. Instruments overall demonstrated poor discrimination, however, all-cause PIVC failure was significantly associated with several individual items in the instruments (e.g., AHPEQS, ‘unexpected physical and emotional harm’). EQ5D-5L demonstrated trivial (ES < 0.20) responsiveness.ConclusionsInitial investigation of an existing health-related quality of life measure (EQ5D-5L) and two patient-reported experience measures (FACIT-TS-G; AHPEQS) suggest they are inadequate (as a summary measure) to assess outcomes and experiences for patients with PIVCs. Reliable instruments are urgently needed to inform quality improvement and benchmark standards of care.