Physical Functional Status Research Articles

Latent transition analysis to explore patterns of physical functional decline among older adults in China: A national 6-year longitudinal study

Background and aimsMultiple limitations often co-occur and accumulate, leading to subsequent function decline. However, there is a scarcity of longitudinal studies examining the progression of physical function among the general population of older adults in China. This study aimed to define typical physical function status and its change, which were characterized by the coexistence and accumulation of diverse limitations targeting a Chinese sample of older adults. MethodsThis study used the three recent public data waves of the Chinese Longitudinal Healthy Longevity Survey during a 6-year follow-up period. 9765 individuals who were over 65 and participated in the 2011 survey were included. Latent transition analysis was used to identify the latent physical function status and explore the transition of older adults among different latent statuses. ResultsSeven latent statuses of physical function were identified, with visual impairment and related limitations being particularly prevalent among older adults. Upper limb mobility appeared to be a differentiated indicator of physical functional status. Physical function decline mainly started with the limitations in squatting, carrying weights and walking, then to the status with intact upper limb mobility and hearing function only, or converted directly into the latter, then to complete dysfunction. ConclusionsOur findings suggest some indicative limitations and critical steps in the process of functional decline among older adults. These results may provide insight for researchers and policymakers to develop tailored preventive and rehabilitation care and provide support for physically limited elderly according to their latent status and course of functional decline.

The effect of burdensome symptoms and functional status on quality of life among older patients with cancer: A correlational study

PurposeThe current study aimed to assess the effect of burdensome symptoms and functional status on QoL among Jordanian older patients with cancer presenting to outpatient clinics. MethodsA correlational design was implemented to collect data from 165 older patients with cancer visiting outpatient oncology clinics. ResultsGenerally, the participants have a relatively low quality of life (M = 52.22 ± 24.57). The highest needs according to their functional status were difficulty walking a long distance (M = 3.06 ± 1.004; physical functional status), feeling limited in pursuing hobbies or leisure time activities (M = 2.32 ± 1.05; role functional status), feeling nervous (M = 2.36 ± 1.01; emotional functional status), having difficulty concentrating (M = 2.15 ± 1.04; cognitive functional status), and that physical condition or medical treatment interfered with their social activities (M = 2.36 ± 1.10; social functional status). Further, the most common distressing symptom was insomnia (n = 90, 54%), followed by fatigue (n = 79, 47.9%). Lastly, quality of life improved with better functional status (the strongest correlation was with the role functional status: r = 0.503, p < .001) and declined with higher symptom severity (the strongest correlation was with fatigue: r = −0.566, p < .001). ConclusionsTo conclude, the current study sheds light on older patients with cancer burdensome symptoms and functional status and their effect on quality of life. The findings suggest that patients suffer from several functional limitations and distressing symptoms that affect their quality of life, necessitating screening and corrective actions from healthcare providers.

High protein provision of more than 1.2 g/kg improves muscle mass preservation and mortality in ICU patients: A systematic review and meta-analyses

ICU patients lose muscle mass rapidly and maintenance of muscle mass may contribute to improved survival rates and quality of life. Protein provision may be beneficial for preservation of muscle mass and other clinical outcomes, including survival. Current protein recommendations are expert-based and range from 1.2 to 2.0g/kg. Thus, we performed a systematic review and meta-analysis on protein provision and all clinically relevant outcomes recorded in the available literature. We conducted a systematic review and meta-analyses, including studies of all designs except case control and case studies, with patients aged ≥18 years with an ICU stay of ≥2 days and a mean protein provision group of ≥1.2g/kg as compared to <1.2g/kg with a difference of ≥0.2g/kg between protein provision groups. All clinically relevant outcomes were studied. Meta-analyses were performed for all clinically relevant outcomes that were recorded in ≥3 included studies. A total of 29 studies published between 2012 and 2022 were included. Outcomes reported in the included studies were ICU, hospital, 28-day, 30-day, 42-day, 60-day, 90-day and 6-month mortality, ICU and hospital length of stay, duration of mechanical ventilation, vomiting, diarrhea, gastric residual volume, pneumonia, overall infections, nitrogen balance, changes in muscle mass, destination at hospital discharge, physical performance and psychological status. Meta-analyses showed differences between groups in favour of high protein provision for 60-day mortality, nitrogen balance and changes in muscle mass. High protein provision of more than 1.2g/kg in critically ill patients seemed to improve nitrogen balance and changes in muscle mass on the short-term and likely 60-day mortality. Data on long-term effects on quality of life are urgently needed.

Patient-Reported Outcomes among Multiple Myeloma Patients Treated with Standard of Care Idecabtagene Vicleucel.

Idecabtagene vicleucel (ide-cel) was the first FDA-approved chimeric antigen receptor T-cell therapy for relapsed/refractory multiple myeloma (RRMM) patients. This was the first study to evaluate patient-reported outcomes (PROs) among RRMM patients receiving ide-cel in standard of care (SOC). We prospectively assessed health-related quality of life (HRQOL) and symptoms from pre-infusion (baseline) through day (D)90 post-infusion. Baseline PRO associations with patient characteristics, mean PRO changes, and time to stable change were evaluated with t-tests, linear mixed-effects models, and Kaplan-Meier analyses, respectively. Within-person change scores and minimally important difference thresholds determined clinical and meaningful significance. Participants (n = 42) were a median of 66 years old (range: 43-81). At baseline, extramedullary disease was associated with worse physical well-being (p = 0.008), global pain (p < 0.001), performance status (p = 0.002), and overall symptom burden (p < 0.001). Fatigue (p < 0.001) and functional well-being (p = 0.003) worsened by D7 before returning to baseline levels. Overall HRQOL (p = 0.008) and physical well-being (p < 0.001) improved by D60. Most participants reported PRO improvement (10-57%) or maintenance (23-69%) by D90. The median time it took to stabile deterioration in functional well-being was 14 days. The median time it took to stabile improvement in physical and emotional well-being was 60 days. Overall, RRMM patients reported improvements or maintenance of HRQOL and symptom burden after SOC ide-cel.

Analysis of clinical efficacy of comprehensive nursing intervention on elderly patients with hypertension combined with hyperuricemia.

To evaluate the clinical efficacy of the comprehensive nursing intervention on elderly patients with hypertension combined with hyperuricemia. This was a retrospective study. One hundred elderly patients with hypertension combined with hyperuricemia admitted to the Baoding No.1 Central Hospital from May 2019 to May 2020 were included and randomly divided into two groups. Patients in the control group were treated with conventional nursing intervention, while those in the experimental group were treated with comprehensive nursing intervention based on the therapy in the control group. The improvement of compliance behavior, clinical efficacy, quality of life and satisfaction with hypertension combined with hyperuricemia before and after treatment were compared and analyzed between the two groups. The proportion of patients in both groups who developed gout or renal insufficiency was recorded, and their long-term treatment outcomes were compared and analyzed. After the comprehensive nursing intervention, the number of cases of compliance behaviors in the experimental group was significantly higher than that in the control group(p<0.05). The systolic and diastolic blood pressure and uric acid levels were significantly lower in the experimental group compared to the control group after the intervention(p=0.00). The scores of physical function, psychological function, social function and material life status improved significantly in the experimental group compared to the control group after the intervention(p=0.00). The satisfaction rate of the experimental group was significantly higher than the control group(p=0.02). The proportion of patients in the experimental group who developed gout was significantly lower than that in the control group(p=0.03). Comprehensive nursing intervention plays a vital role in the treatment and prognosis of hypertension combined with hyperuricemia.

Geriatric assessment for older people with cancer: policy recommendations

Most cancers occur in older people and the burden in this age group is increasing. Over the past two decades the evidence on how best to treat this population has increased rapidly. However, implementation of new best practices has been slow and needs involvement of policymakers. This perspective paper explains why older people with cancer have different needs than the wider population. An overview is given of the recommended approach for older people with cancer and its benefits on clinical outcomes and cost-effectiveness. In older patients, the geriatric assessment (GA) is the gold standard to measure level of fitness and to determine treatment tolerability. The GA, with multiple domains of physical health, functional status, psychological health and socio-environmental factors, prevents initiation of inappropriate oncologic treatment and recommends geriatric interventions to optimize the patient’s general health and thus resilience for receiving treatments. Multiple studies have proven its benefits such as reduced toxicity, better quality of life, better patient-centred communication and lower healthcare use. Although GA might require investment of time and resources, this is relatively small compared to the improved outcomes, possible cost-savings and compared to the large cost of oncologic treatments as a whole.

Pulmonary rehabilitation and risk of fall in elderly with chronic obstructive pulmonary disease.

Few data are available on the effects of pulmonary rehabilitation (PR) on risk of fall in over 80 individuals with chronic obstructive pulmonary disease (COPD). We investigated the effectiveness of PR on the risk of fall in older as compared to younger than 80 individuals. Parallel-group retrospective exploratory study of individuals undergone in-hospital PR. The risk of fall was defined as a gait speed ≤0.8 m/s (primary outcome). Outcome measures (exercise capacity, physical performance, symptoms, and health status) were also assessed. As compared to younger, individuals over 80 suffered from more severe symptoms, a reduction in physical performance and in exercise capacity and greater risk of fall (P=0.0001). The proportion of participants at risk of fall increased with age, and after PR decreased significantly without any significant difference between age groups. However, 53.4% of older individuals were still at risk of fall, as compared to 17.5% of those under 80 (P=0.0001). After PR, both populations had improved outcomes measures, without any significant between group differences. In individuals with COPD pulmonary rehabilitation reduced the risk of fall, while improving outcome measures independent of age, however, more than 50% of those over 80 were still at risk of fall. The pulmonary rehabilitation programs for individuals over 80 should include strategies effective in reducing the risk of fall.

Elevated serum leptin may be associated with disease activity and secondary osteoporosis in Chinese patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is a systemic chronic autoimmune disease in adults that is associated with significant joint issues and systemic inflammation. One of the signs of bone damage in RA is osteoporosis (OP). Leptin is an inflammatory protein that has been reported to be related to RA. The potential relationships among leptin, disease activity, and OP in Chinese patients with RA are not well known. In total, 245 patients with RA and 120 healthy controls were included in this study. Detailed data on the clinical characteristics and laboratory features were collected. Information about physical activity and functional status was recorded using specific questionnaires. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The MECALL castor-50-hf model X-ray scanner was used for the two-hand (including wrist) photographs. Serum leptin levels differed significantly between the RA group and healthy control subjects (1.27/3.29 vs. 0.17/0.24, Z=13.29, P<0.001). The positive rate of leptin protein in RA patients was 86.35%, which was higher than that in controls (19.55%) (χ2=28.51, P<0.001). Pearson's correlation test showed that morning stiffness, disease duration, joint swelling, joint tenderness, swollen joint count (SJC), tender joint count (TJC), health assessment questionnaire (HAQ) score, and Sharp-van der Heijde method (Sharp) score were positively correlated with the level of serum leptin (r=0.212, r=0.312, r=0.322, r=0.501, r=0.291, r=0.334, P<0.05). There was a clear increasing trend in the level of serum leptin according to the different disease activity scores and in the 28 joint activity (DAS28) groups (F=13.936, P<0.001). Elevated leptin was a risk factor for increased disease activity and OP according to logistic regression analysis. The median leptin level differed significantly between the normal bone mass group, osteopenia group, and OP group (P<0.001). An increased serum leptin level was a risk factor for RA-induced osteoporosis according to logistic regression analysis (P<0.001). These results suggest that the level of serum leptin is associated with disease activity and secondary OP among Chinese patients with RA. Key Points • Serum leptin levels in RA patients are higher than those in normal control group. • Leptin was associated with disease activity. • Leptin was associated with the occurrence of systemic osteoporosis and affects bone erosion in RA patients.

Relationship between body weight and indicators of physical and emotional status in 12-13-year-old girls

This article is focused on assessing the influence of body weight on the indicators of physical and emotional status of 12-13-year-old girls. The aim of the study was to examine the relationship between body weight and indicators of physical and emotional status in 12-13-year-old girls. The study involved 108 girls aged 12 and 30 girls aged 13. The following methods were used: analysis of scientific and methodological literature, anthropometric, pedagogical, physiological methods, and methods of mathematical statistics. Results. The study revealed statistically significant (p &lt; 0.05) correlations between body mass index (BMI) and indicators of physical development, functional status, physical fitness, physical activity, and value orientations of 12-13-year-old girls, as well as factors negatively influencing their attitude towards physical education classes. The study also identified a direct statistically significant relationship between BMI and the value orientations in the subjects. An increase in BMI was associated with the reinforcement of terminal values such as independence and love, as well as instrumental values like cheerfulness. The research revealed that normal body weight has a positive impact on the development of physical abilities of 12-13-year-old girls, specifically agility and trunk flexor muscular strength and endurance. According to the obtained data, the number of correlations between BMI and other studied indicators of physical and emotional status, physical activity, and value orientations increased with age. While 12- year-old girls had 12 such correlations, 13-year-old girls had 15. Conclusions: The abovementioned necessitates the consideration of these findings in the justification and development of exercise programs based on the use of health fitness means for girls with insufficient body weight.

FTP5.2 Functional deficits in older patients undergoing major gastrointestinal surgery

Abstract Aim Gastrointestinal surgeons face an increasingly complex patient population. Patients are older, often with co-morbidities, frailty, nutritional, functional, and cognitive impairments. The aim of this study was to compare functional outcomes of a cohort of older patients following emergency and elective major gastrointestinal surgery. Methods A prospective cohort study in 3 NHS trusts was performed (NCT04545125). Baseline comprehensive assessment including quality of life, physical activity levels, functional, nutritional, and cognitive status was performed. Functional status (WHODAS v2, &amp; Activities of Daily living questionnaire) and quality of life (EQ-5D-5L) were assessed at baseline, 6 weeks, 3 months, and 6 months following surgery. Results Ninety-eight patients were recruited; median age 74 years, 56% male. Eighty-two patients underwent elective surgery and 16 underwent emergency surgery. At baseline, 13.9% elective vs 68.8% emergency patients were considered vulnerable or frail on frailty testing; 35.9% elective vs 62.5% emergency were identified as malnourished or at risk of malnutrition. Emergency patients had lower Independent Activities of Daily Living score median 6 versus 8 (p=0.007). Baseline activity was lower in emergency patients compared to elective; 1,386 vs 3,882 MET minutes per week (p=0.06). Functional status and quality of life appeared to recover in elective patients by three months, however this was lower at baseline in emergency patients and this persisted over follow-up. Conclusion High levels of baseline functional, cognitive and nutritional deficits were found in this study. Whilst elective patients appear to recover within 3 months, emergency patients have persistent deficits in functional capacity and quality of life.

Relationship Between Cortisol Rhythm and Psychoneurological Symptom Cluster in Patients With Advanced Lung Cancer.

Patients with advanced lung cancer commonly experience a high prevalence of physical and psychological symptoms, which tend to co-occur as a symptom cluster. Cortisol rhythm has the potential to influence psychoneurological symptom cluster based on neuroendocrine-immune models; however, little is known about the relationship between them. To examine the intercorrelation among symptoms in psychoneurological symptom cluster and the factors influencing the severity of psychoneurological symptom cluster. One hundred sixty-one patients with advanced lung cancer were recruited from 2018 to 2020 as part of a large study. Data on sleep disturbances, fatigue, and psychological distress were collected via self-report questionnaires, and the diurnal cortisol slope was analyzed using saliva samples. Linear regression analyses were adopted to examine the association between cortisol rhythm and demographic and clinical variables with psychoneurological symptom cluster. Psychoneurological symptoms (including sleep disturbances, fatigue, anxiety, and depression) were significantly correlated. Poor physical performance status (β = -0.061, P < .001), increased number of comorbidities (β = 0.533, P < .001), and flatter cortisol rhythm (β = 545.092, P < .001) were significantly associated with higher-severity psychoneurological symptom cluster. Diurnal cortisol slope (β = 328.829, P = .025) was identified as the most critical factor influencing the psychoneurological symptom cluster in multiple linear regression model after adjusting for covariates. Patients with flatter diurnal cortisol slopes were found to experience more severe psychoneurological symptom cluster, after controlling for demographic and clinical factors. Interventions targeting the improvement of associated factors, such as comorbidities and physical performance status, could potentially alleviate the severity of the psychoneurological symptom cluster.

Effects of COVID-19 Experience on Physical Activity and Functional Status in Daily Life

Effects of COVID-19 Experience on Physical Activity and Functional Status in Daily Life

Social Isolation and Loneliness in a Population Study of Cognitive Impairment: The MYHAT Study.

In this study, we examined associations of social isolation and loneliness with cognitive impairment among older adults from a Rust Belt region in Southwest Pennsylvania. We used data from the population-based Monongahela-Youghiogheny Healthy Aging Team (MYHAT) study. We found that (a) 11 items combined into two reliable composites of social isolation and loneliness; (b) unique to this study, providing unpaid help to others was an indicator of reduced social isolation; (c) social isolation and loneliness were positively associated with cognitive impairment; and (d) these associations were appreciably attenuated by general health and physical functional status and depressive symptoms, respectively. We concluded that social isolation and loneliness are differentially associated with older adults' cognitive health, and that their effects might operate through separate pathways. Approaches to address social isolation and loneliness should consider the community context and its implications for older adults' cognitive health.

Verbal Encouragement Improves Game Intensity, Technical Aspects, and Psychological Responses During Soccer-Specific Training.

Soccer match outcomes rely on technical accuracy, intensity of play, and athlete motivation, and these parameters can be developed during sport-specific practice such as during small-sided games (SSGs). Verbal encouragement as a coaching technique improves exercise intensity and athlete enjoyment (indicative of motivation), but the impact on technical performance alongside these critical parameters remains unknown. To examine the effects of verbal encouragement on technical performance, exercise intensity, and enjoyment during SSGs. Sixteen male youth soccer players (mean [SD]; age: 17.2 [0.4]y; height: 176.3 [7.0]cm; body mass: 68.0 [4.1]kg; body fat: 11.9% [2.2%]) completed 4 sessions of 4-per-side SSG without a goalkeeper. Two sessions were conducted as SSGs with verbal encouragement and 2 without verbal encouragement. Each SSG lasted 25minutes (4 × 4-min work, 3-min passive recovery between bouts) on a 25 × 35-m pitch. Heart rate (HR) was continuously recorded, and rating of perceived exertion was collected after each SSG. Video analysis was used to quantify technical actions during SSG. Enjoyment was assessed after each SSG using the Physical Activity Enjoyment Scale. Paired t tests revealed that SSGs with verbal encouragement induced higher HR (% maximum HR and mean HR), rating of perceived exertion, and Physical Activity Enjoyment Scale score than SSGs without verbal encouragement (all P < .001, all d ≥ 0.92, large). Compared with SSGs without verbal encouragement, SSGs with verbal encouragement resulted in an increased percentage of successful passes (P < .001, d = 0.73, medium) and number of interceptions (P < .001, d = 0.89, large) and fewer lost balls (P < .001, d = 0.68, medium). Coaches should use verbal encouragement during SSGs to improve physical effort, technical performance, and psychological status in soccer players.

Nordic Walking - The Effectiveness of a New Form of Exercise in Adults After COVID-19 Infection: A Randomized Controlled Trial

The purpose of present study was investigating the effectivenes of Nordic walking exercise (NWE) on physical activity level, physical fitness level, dyspnea, fatigue, functional status, depression and life quality after COVID-19 undergoing home isolation.Thirty subjects were randomly assigned in NWE (n=15) and control group (n=15). NWE group performed NWE 3 days a week for 6 weeks. The control group was not given any exercise. For physical fitness level, upper-lower extremity muscular endurance (arm curl test- chair sit and stand test), lower aerobic (two minutes step test) and cardiopulmonary endurance (six minute walk test), flexibility (back scratch and sit and reach test), balance (time up and go test) was assessed. The International Physical Activity Questionnaire Short Form (IPAQ-SF) was used to evaulate physical activity level. The anxiety-depression level was determined by Beck Depression Questionnaire. The dyspnea with Modified Medical Research Council (mMRC), functional status with Post-COVID-19 Functional Status Scale (PCFS), fatigue with Fatigue Severity Scale (FSS) and quality of life with Nottingham Health Profile (NHP) were determined. In NWE group, significant improvements were observed in upper-lower muscular extremity, lower aerobic, cardiopulmonary endurance, balance, mMRC, FSS, NHP energy, emotional reactions, sleep and total scores (p&amp;lt;0.05). Upper-lower muscular extremity, lower aerobic, cardiopulmonary endurance, balance, PCFS, IPAQ-SF walking and NHP energy scores were statistically different between groups in favor of NWE group (p&amp;lt; 0.05). NWE can be recommended physical activity program to improve physical health and functional status after COVID-19.

Outcomes of Calvarial and Soft-Tissue Reconstruction with Latissimus Dorsi-Rib Osteomyocutaneous Free Flap.

The latissimus dorsi-rib osteomyocutaneous free flap (LDRF) has been used for autologous reconstruction of large composite calvarial and scalp defects. In this study, the authors aim to present clinical and patient-reported outcomes after LDRF reconstruction. An anatomical study was conducted to evaluate the distribution of the connecting perforators between the thoracodorsal and intercostal systems. An institutional review board-approved retrospective review of 10 patients who underwent LDRF with one or two ribs for treatment of cranial defects was conducted. Patient-reported outcomes regarding quality of life, neurologic status, and functional status were evaluated using validated surveys. One-way analysis of variance and post hoc Tukey tests were used for anatomical outcomes. Preoperative and postoperative scores were compared using paired t tests. The tenth rib (4.65 ± 2.01) followed by the ninth rib (3.7 ± 1.63) had the highest number of perforators. A combination of the ninth and eleventh ribs exhibited maximal perforator number and pedicle length. All patients had stable LDRF reconstructions. Eight patients completed both preoperative and postoperative questionnaires; Median clinical follow-up was 48 months (range, 34 to 70 months). Scores trended toward improvement but did not reach statistical significance on the Karnofsky Performance Scale ( P = 0.22), the Functional Independence Measure (Motor, P = 0.52; Cognitive, P = 0.55), or the Headache Disability Index ( P = 0.38). The minimum clinically important difference was surpassed, demonstrating improvement of function for 71% of patients on the Barthel Index and 63% on the Selective Functional Movement Assessment test. The LDRF can improve cognitive and physical functional status in complex patients with prior failed reconstructions for composite scalp and skull defects. Therapeutic, IV.

Physical activity and functional status in older adults: Mediating effect of cognitive function

AbstractBackgroundOlder adults who participate in social activities have more active lifestyles which has been shown to improve their quality of life (Acree et al., 2006). Generally instrumental activities of daily living (IADL) require aspects of social participation (e.g., cooking and managing finances) (Guo &amp; Sapra, 2020). A previous study reported that physical and cognitive functions are positively associated with functional status in IADLs (Yam &amp; Marsiske, 2013). In addition, since physical activity is associated with cognitive function, active participation in physical activity is recommended to maintain and improve cognitive function. While a number of studies have investigated the relationship between physical activity, cognitive function, and IADL, it is not clear if cognitive function acts as a mediator between physical activity and functional status equation. The aim of this study was to examine the relationship between physical activity and IADL and to clarify the mediating effect of cognitive function.MethodA retrospective cross‐sectional design that analyzed the association between physical activities and IADL and the mediating effects of cognitive function. We retrieved 3,980 people from the 6 million recipients eligible for the Korean health insurance and benefits, between years 2002 and 2015. The included people in this analysis are 60 years and older and have completed the physical activity questionnaire. We estimated the indirect effect of physical activities through cognitive function on IADL performance.ResultThe average age of the participants was 81.6 years (SD = 5.5), and 72.74% were female. There were a direct effect of high‐intensity exercise on IADL (β = 0.04, 95% CI: 0.01, 0.07) and an indirect effect of high‐intensity exercise through cognitive function (β = 0.05; 95% CI: 0.04, 0.07). In addition, there were a direct effect of moderate‐intensity exercise and IADL (β = 0.04, 95% CI: 0.01, 0.07) and an indirect effect of moderate‐intensity exercise through cognitive function (β = 0.05; 95% CI: 0.04, 0.07).ConclusionThe study indicated that there were positive relationships between physical activities, cognitive function and IADL. In addition, there was a mediating effect of cognitive function on the relationship between physical activities and IADL.

THU-443 - NAFLD prevalence in the elderly declines with age and is associated with increased frailty, reduced physical function and social disadvantage status: results from the ASPREE study

THU-443 - NAFLD prevalence in the elderly declines with age and is associated with increased frailty, reduced physical function and social disadvantage status: results from the ASPREE study

Factors Related to Oral Problems in Patients with Prolonged Disorders of Consciousness in Long-Term Care: A Cross-Sectional Study.

Factors influencing oral problems, such as malocclusion and oral motor dysfunction, in patients with prolonged disorders of consciousness (DOC) remain unclear. This study aimed to clarify the relationship between oral problems and physical function, communication, respiration, and oral intake status, as well as related factors in patients with DOC receiving long-term care at home. A cross-sectional study was conducted in October 2018; 127 patients who developed DOC > 5 years ago were analyzed. The differences between patients with and without oral problems were examined, and a binomial logistic regression analysis was performed to examine factors associated with oral problems, with the presence of oral problems as the dependent variable, and age, the number of years since onset, drooling, oral intake status, and the presence of a family dentist as explanatory variables. A post hoc power analysis of the binomial logistic regression analysis for oral problems (odds ratio: 2.05, alpha value: 0.05, incidence of oral problems: 0.80, and total sample size: 127) demonstrated an observed power of 93.09%. Oral intake status (p = 0.010) and the number of years since onset (p = 0.046) were significantly related to oral problems. Preventive oral management and rehabilitation from the early stage after onset may be effective for oral problems in patients with DOC.

Randomized phase 3 study of tarlatamab, a DLL3-targeting bispecific T-cell engager (BiTE),compared to standard of care in patients with relapsed small cell lung cancer (DeLLphi-304).

TPS8611 Background: Small cell lung cancer (SCLC) is an aggressive malignancy for which very few patients achieve long term disease control; response to most treatments is transient and second line treatment options are limited. Delta-like ligand 3 (DLL3) is a Notch ligand aberrantly expressed on the surface of up to 85% of SCLC cells and minimally expressed in normal tissues, making it an attractive therapeutic target. Tarlatamab is a bispecific T cell engager (BiTE) molecule designed to bind DLL3 on target cancer cells and CD3 on T cells, thereby driving T cell-dependent killing of tumor cells. Results from the first-in-human study in patients with relapsed/refractory SCLC (DeLLphi-300; NCT03319940) demonstrate tarlatamab efficacy in pretreated patients with confirmed responses in 23% of patients and median duration of response &gt; 12 months.1 Median overall survival (OS) was 13.2 months. Grade ≥ 3 treatment-related AEs (TRAEs) occurred in 31% of patients and TRAEs resulted in discontinuation in 4% of patients. This promising efficacy/safety profile is being evaluated further in a phase 2, open-label study in patients with relapsed/refractory SCLC after ≥2 lines of prior treatment (DeLLphi-301; NCT05060016). Methods: NCT05740566 is a randomized, open-label, phase 3 study of tarlatamab compared with standard of care (SOC) in ~700 patients with relapsed SCLC after platinum-based first-line chemotherapy. Patients will be randomized 1:1 to receive tarlatamab or SOC therapy (lurbinectedin or topotecan in US, Canada, Australia, Singapore, Korea; amrubicin in Japan; topotecan in all countries except Japan), stratified by prior anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) exposure, chemotherapy-free interval, presence of brain metastases, and SOC (topotecan/amrubicin vs lurbinectedin). The primary objective is to compare the efficacy of tarlatamab with SOC on prolonging OS. Key secondary endpoints include comparison of progression free survival (PFS) based on investigator assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and patient-reported outcomes (PRO) including disease-related symptoms, physical function, and global health status of quality of life. Key eligibility criteria include adults with histologically or cytologically confirmed relapsed SCLC who progressed following 1 platinum-based regimen. Patients must have measurable lesions as defined per RECIST 1.1 within the 21-day screening period and must have adequate organ function. Exclusions include untreated or symptomatic central nervous system metastases, history of immune checkpoint inhibitor use resulting in severe immune-mediated adverse event, and previous history of NSCLC. Enrollment is ongoing.