Physical Function Scores Research Articles

Comparing Pain Outcomes and Treatment Adherence Between In-Person and Virtual Interdisciplinary Pain Rehabilitation Programs at the San Francisco VA Health Care System.

This study compares clinical pain outcomes between patients in a pain treatment program that was conducted in-person, compared to a virtual program. In-Person (N=127) and Virtual (N=101) pain treatment programs were compared based on patient-reported, practitioner-collected, and medical record data. The patients were measured at baseline and post treatment (week 12 for In-Person and week 8 for Virtual patients). We employed last observation carried forward (LOCF) to handle missing data. Both the In-Person and Virtual groups were similar in regard to all baseline outcomes, except the In-Person group having significantly more co-morbidities at baseline, with particularly more cases of mental, behavioral, or neurodevelopmental diseases. Both groups demonstrated significant improvements in the pain-related measurements of pain interference and pain catastrophizing thoughts, but neither group displayed a change in average pain across treatment. Further, both groups improved significantly on emotional well-being scores, but not on physical functioning scores. No significant differences existed between groups on outcomes, except for pain catastrophizing, which was higher in the Virtual group at both time points. The Virtual group had lower rates of dropouts compared to In-Person, while the In-Person group had a larger proportion reach a clinically meaningful change in pain-related outcomes, defined as a >30% improvement. While some changes were unique to the In-Person program, overall, patients in the Virtual program achieved similar treatment outcomes, suggesting that it can successfully treat Veterans seeking pain management, with less need for in-person facilities for both patients and clinicians.

Validation of the Integrated Palliative Care Outcome Scale (IPOS) in adults with cystic fibrosis.

A primary palliative care model for cystic fibrosis (CF) recommends using the Integrated Palliative Care Outcome Scale (IPOS) for screening. Validation of the IPOS is needed. This secondary analysis utilized baseline data from a multisite trial of the palliative care model, Improving Life with CF. Adults with CF completed the IPOS, the Memorial Symptom Assessment Scale-CF (MSAS-CF), the CF Questionnaire-Revised (CFQ-R), the Patient Health Questionnaire (PHQ-8), the Generalized Anxiety Disorder (GAD-7), and the Perceived Stress Scale (PSS). IPOS structure was assessed using Cronbach α coefficients and a factor analysis. Construct validity was evaluated through bivariate relationships between IPOS scores and other questionnaire scores, and linear regressions assessing the extent to which the IPOS explains variance in quality-of-life domains. The sample comprised 256 adults with complete IPOS data. α coefficients were .86 for the IPOS total score, .81 for the Physical Symptoms subscale, .79 for the Emotional Symptoms subscale, and .63 for the Communication/Practical Issues subscale. A two-component factor structure best aligned with the current subscales. IPOS scores were significantly associated with other measures; associations with MSAS-CF and CFQ-R subscales differentiated the IPOS Physical and Emotional subscales. The IPOS total score provided unique information about the variance in the CFQ-R Physical Functioning and Respiratory Symptoms domain scores. In adults with CF, the IPOS has acceptable internal consistency and there is evidence of construct validity. These findings support adoption of the IPOS in the primary palliative care model for CF.

Variability in patient-reported outcomes among different congenital heart defects: a comparative analysis of 7,498 patients from 32 countries

Abstract Background Patient-reported outcomes (PROs) may not always correlate with the complexity of congenital heart defects (CHDs), as significant variation has been observed between CHDs within complexity levels. Accurate comparisons across various types of CHDs necessitate large sample sizes. Purpose The objective of this study was to compare PROs across different CHDs in a large international sample. Methods ‘Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease – International Study II’ (APPROACH-IS II) was an international cross-sectional investigation, in which 8,415 patients from 32 countries in 6 continents were enrolled (20 high; 7 upper-middle; 4 lower-middle; and 1 low income). For the comparison across different CHDs, conditions with at least 50 patients were included in the analysis. Hence, the sample consisted of 7,498 patients (median age=33y; 53.1% women). Patients completed questionnaires to measure perceived health status (RAND-12 Health Survey; EuroQOL-5D Visual Analog Scale); depressive symptoms (Patient Health Questionnaire-8); anxiety (General Anxiety Disorder-7) and quality of life (Linear Analog Scale). Generalized linear mixed models (GLMMs) were performed with center as random effect. Results Cyanotic heart defects were associated with the lowest scores for physical functioning, mental health, self-rated health, and quality of life (see Figure). Other CHDs found to be associated with poor PRO scores encompassed unrepaired secundum atrial septal defect, Ebstein anomaly, single ventricle, and truncus arteriosus. Conversely, the most favorable scores for all PROs, except for anxiety, were observed with isolated pulmonic stenosis. Other CHDs with favorable PRO scores comprised coarctation of the aorta, isolated small ventricular septal defect, congenital aortic valve disease, and repaired ventricular septal defect. Adjusted for sociodemographic and physiological factors, GLMMs revealed significant differences across defects, using the best score for each PRO as the reference (see Figure). Conclusion Substantial variation in PROs was observed among different types of CHDs. Interestingly, some complex heart defects demonstrated relatively good PRO scores, comparable to some simple defects. On the other hand, unrepaired simple defects or those with residual lesions, were associated with worse PROs.

Impact of Atezolizumab + Bevacizumab Therapy on Health-Related Quality of Life in Patients with Advanced Hepatocellular Carcinoma

Background/Objectives: Health-related quality of life (HRQoL) is critical in patients with hepatocellular carcinoma (HCC). It has become a key endpoint in the evaluation of new therapies, including atezolizumab + bevacizumab (Atezo + Bev) therapy. Methods: This study explored the factors associated with treatment efficacy, treatment duration, and overall survival (OS) in patients with advanced HCC undergoing Atezo + Bev therapy. We included 58 consecutive patients with HCC receiving Atezo + Bev from 19 November 2020, to 28 December 2023, who were followed up until the end of the study or death. We analyzed the relationships between baseline characteristics, adverse events (AEs), and HRQoL and efficacy, OS, and treatment duration. Results: The demographic (older men) and baseline characteristics (Child–Pugh score of 5, Barcelona Clinic Liver Cancer Stage C) were consistent with those of previous studies. The treatment demonstrated promising efficacy with a disease control rate of 71.2%, but HRQoL scores in five functional domains and seven symptoms worsened significantly within the first 3 months. Notably, better baseline cognitive and physical function scores and absence of severe (grade ≥ 2) hypoalbuminemia were associated with an improved objective response rate, longer treatment duration, and better OS. Conclusions: These findings underscore the importance of monitoring and managing treatment-related AEs and maintaining the HRQoL. They also highlight the crucial and reassuring role of multidisciplinary care in enhancing treatment outcomes in this cohort.

Predictors of time to achieve clinically significant improvements following lateral lumbar interbody fusion

BackgroundAs lateral lumbar interbody fusions (LLIF) are increasingly performed, our understanding of postoperative clinical trajectories is important in informing preoperative patient expectations. While minimum clinically important difference (MCID) rates are widely utilized in spine surgery literature, there is less published on how long it takes for patients to achieve MCID following LLIF. ObjectiveTo evaluate the length of time it takes for patients to report MCID achievement for back pain, leg pain, disability, and physical function and evaluate predictors of time to achieve MCID. MethodsPatients undergoing elective LLIF by the senior author with baseline and postoperative patient-reported outcomes (PROs) recorded were retrospectively identified. Data on potential predictors of time to MCID achievement were gathered including demographics, comorbidities, diagnostic information, and baseline PROs. MCID achievement rates for Oswestry Disability Index (ODI), Visual Analog Scale-Back (VAS-Back), VAS-Leg, and Patient-Reported Outcome Measurement Information System-Physical Function (PROMIS-PF) were calculated at six-, twelve, 6 month- 1 year- and 2-year postoperative timepoints. A Kaplan-Meier survival analysis was conducted to determine the proportion of patients achieving MCID at each time point. A multivariate Cox regression determined predictors of time to MCID achievement. ResultsOne hundred-five patients were included in the analysis. The mean time to achieve MCID for PROMIS-PF was 44.7 weeks, for VAS-Back was 38.5 weeks, for VAS-Leg was 36.7 weeks, and for ODI was 38.3 weeks. Worse baseline VAS-Back significantly predicted earlier MCID achievement for VAS-Back (HR: 1.55), while diabetes was predictive of later MCID achievement (HR: 0.21). Higher body mass index and worse preoperative ODI predicted earlier MCID achievement for ODI (HR: 1.04–1.08), and higher VAS-Leg score and two-level fusion were predictive of later MCID achievement for ODI, (HR:0.26–0.81). Worse preoperative VAS-Leg, isthmic spondylolisthesis, and three-level fusion were predictors of earlier achievement of MCID for VAS-Leg (HR: 1.27–6.47). Herniated nucleus pulposus and foraminal stenosis were early predictors (HR: 2.92–3.23) and workers’ compensation was a late predictor of MCID attainment for PROMIS-PF (HR: 0.13). ConclusionSelect demographic variables, comorbidities, spinal pathology, and preoperative PROs influenced the time it took for patients to report clinically significant improvements in pain, disability, and physical function scores. These findings can be used to prognosticate outcomes for patients undergoing LLIF and inform patient expectations of postoperative recovery.

Comparison of Patient-Reported Outcomes after Local Flap Coverage versus Amputation for Complex Lower Extremity Trauma

Abstract Background There is a paucity of patient-reported outcomes (PROs) data in lower extremity salvage. Limb salvage can often be achieved with the use of local muscle flaps or fasciocutaneous flaps. The purpose of this study was to compare PROs of patients who underwent lower extremity salvage using local fasciocutaneous flaps or muscle flaps to lower extremity amputation. Materials and Methods The outcomes of 61 patients that underwent lower extremity local flap reconstruction (n = 33) or amputation (n = 28) between 2014 and 2020 were recorded. Chart reviews were performed to collect perioperative data. Patients were contacted via telephone for participation in the survey portion of our study. PROs were recorded utilizing both the Lower Extremity Functional Scale (LEFS) and the 36-Item Short-Form Health Survey (SF-36). Results Surveys were completed by 61 patients (response rate 59.2%). The mean time of survey after flap reconstruction or amputation was 2.7 ± 1.4 years. Recent trauma (within 90 days) was the most common indication for local flap coverage (n = 23). LEFS score and SF-36 physical functioning scores were significantly lower in patients who underwent muscle flaps compared with fasciocutaneous flaps (p = 0.021 and p = 0.022). Muscle flap patients had similar LEFS and SF-36 scores to amputation patients, while fasciocutaneous flap patients had significantly higher LEFS (p = 0.01), SF-36 physical functioning (p = 0.031), physical role functioning (p = 0.031), and emotional role functioning (p = 0.047) scores than amputation patients. Conclusion Patients who underwent local fasciocutaneous flaps for limb salvage reported higher PRO scores than those undergoing amputation, while patients undergoing muscle flaps reported outcomes similar to those undergoing amputation. PROs for muscle flap patients were significantly lower than those of fasciocutaneous flap patients. These data suggest that while fasciocutaneous and muscle flaps are both useful limb salvage procedures, fasciocutaneous flaps may confer advantages that result in improved patient-perceived outcomes. Further study is needed to better characterize outcomes in limb salvage.

THE EFFECT OF EXERCISES OF DIFFERENT INTENSITY APPLIED AFTER TOTAL KNEE ARTHROPLASTY ON POST-OPERATIVE PAIN: RANDOMIZED CONTROLLED TRIAL

Purpose: This study aimed to investigate the changes in pain following exercise sessions with different intensities in patients who underwent total knee arthroplasty (TKA). Methods: This is a repeated measure and single-blinded randomized controlled study. Thirty-six patients who underwent TKA (age, 64.9 ± 7.42 years) were randomly assigned to either low-intensity exercises (LIEs) group or high-intensity exercises (HIEs) group. Exercise programs lasted for five days during the hospitalization period. Pain intensity was assessed by visual analog scale (VAS) and pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscale (pain, stiffness, and physical function) scores were recorded at two points in baseline and discharge from the hospital. Results: The pain intensity decreased in patients in both groups after TKA. PPTs increased in both groups at all tested sites following the first, third, and fifth exercise bouts. HIE program had a greater positive effect on the pain intensity after the first exercise session than LIE program on the PPTs ([Formula: see text] < 0.05). HIE program was more effective in order to reduce pain severity immediately after the exercise sessions in patients ([Formula: see text]: 0.5, [Formula: see text] < 0.05). WOMAC scores significantly improved in both groups during the discharge from the hospital ([Formula: see text] = 0.001). Conclusion: Our results found that both LIE and HIE programs performed during hospitalization after TKA declined pain intensity. Particularly notable were the substantial improvements observed in managing post-operative pain, especially following the second exercise session. The HIE program proved more effective in improving stiffness, and enhancing physical function.

Comparative analysis of clinical outcomes of talocalcaneal coalition resection: subtalar joint middle and posterior facet involvement versus isolated posterior facet involvement – a retrospective cohort study

BackgroundDespite coalition resection being the preferred treatment for talocalcaneal coalition (TCC), postoperative complications, suboptimal functional recovery, and recurrence risks remain challenges. Although current TCC classification systems guide personalized surgical plans, the impact of middle and posterior facet coalitions on TCC resection surgery’s effectiveness is still poorly understood. Therefore, this study aims to compare the clinical outcomes of TCC patients with and without involvement of the subtalar joint’s (STJ) middle and posterior facets undergoing coalition resection to explore the potential impact of these coalitions on surgical outcomes.MethodsWe conducted a retrospective study on 115 patients who underwent coalition resection surgery due to symptomatic TCC between November 2009 and February 2023. According to preoperative CT scan results, patients were divided into an isolated posterior facet coalition (P-type) group and a middle-posterior facet coalition (MP-type) group. Demographic characteristics (including age, sex, body mass index (BMI), follow-up time, and medical history duration), pre-and postoperative assessments (including Visual Analog Scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Pain Interference (PI) and Physical Function (PF) scores from the Patient-Reported Outcomes Measurement Information System (PROMIS)), as well as postoperative self-assessment of efficacy (excellent, good, fair, poor) and hindfoot stiffness, were compared between the two groups. Postoperatively, TCC recurrence was evaluated through imaging follow-up examinations.Results69 patients meeting the inclusion criteria were included, with 30 patients in the P-type group and 39 in the MP-type group. There were no statistically significant differences between the two groups in demographic characteristics (P<0.05). There were also no statistically significant differences between the two groups in preoperative VAS score, AOFAS score, PI score, and PF score. However, postoperatively, there were statistically significant differences between the two groups in VAS score (1(1,1.5) vs. 2(1,2), P<0.01), AOFAS score (92.5(87,96.5) vs. 82(69.5,87), P<0.01), PI score (39(39,43) vs. 39(39,51), P = 0.014), PF score (73(61,73) vs. 55(51,73), P = 0.001), fair or poor outcome (4(13%) vs. 14(35.9%), P = 0.034), and hindfoot stiffness (3(10.3%) vs. 16(37.2%), P = 0.011). There was no statistically significant differences in the recurrence rate between the two groups postoperatively (0(0%) vs. 3(7.69%), P = 0.252).ConclusionEven with complete coalition resection during surgery and rehabilitation following standardized protocols, the surgical outcomes in MP-type TCC patients are still inferior to those in P-type patients.

Hardware Removal After Lisfranc ORIF Results in Improved Physical Function.

The purpose of this study was to investigate whether HWR after Lisfranc ORIF resulted in significant impact via PROMIS physical function (PF) and pain intensity (PI) scores. Design: Retrospective cohort. Level-1 trauma center. Adult patients with isolated Lisfranc injuries who were treated via ORIF between 2002-2023 that had PROMIS PF and PI scores through 6 months follow-up were included. Patients were excluded if they received index treatment other than ORIF or underwent secondary surgical intervention prior to HWR. A sub analysis was performed at 1 year follow- up. Primary outcomes were PROMIS PF and PI scores. The Wilcoxon signed-rank test compared differences between PROMIS scores within the HWR group. The Wilcoxon ranked-sum test compared differences between HWR vs no HWR. Distributive MCID was calculated using the 0.5 SD method. There were 482 patients (489 feet) identified with isolated Lisfranc injuries. Seventy-seven feet underwent ORIF followed by HWR. Thirty feet underwent ORIF without HWR. The average age of the no HWR group was 45.8 (18.0-81.3) versus the HWR group which was 38.7 (18.3-74.1) (p=0.053). Nineteen (63.3%) were female in the no HWR group compared to 33 (42.9%) in the HWR group (p=0.084). HWR occurred an average of 4.43 months after ORIF. Patients who underwent HWR had a statistically significant increase in average PF scores (39.7 to 45.9, p<0.001) at their standard 6 week (1.5 month) postoperative visit. HWR patients had a non-significant decrease in average PI scores (56.5 to 53.9, p=0.24). Compared to those with retained hardware, the HWR group demonstrated a statistically significant net improvement in PF and PI scores from surgery, with an average improvement of 5.6 and 1.7, respectively (P=0.002, 0.008). Patients experienced significant improvement in PROMIS PF scores for Lisfranc ORIF at 6 weeks after HWR. Compared to patients with retained hardware, they also experienced significant improvement in PROMIS PF and PI scores. III.

Functional outcome and histologic analysis of late onset total type brachial plexus injury treated with intercostal nerve transfer to median nerve with local umbilical cord-derived mesenchymal stem cells or secretome injection: a double-blinded, randomized control study.

Intercostal nerve transfer is a surgical technique used to restore function in patients with total brachial plexus injury. Stem cell and secretome therapy has been explored as a potential treatment for brachial plexus injuries. This study aimed to compare the functional and histologic outcome of intercostal nerve transfer to median nerve with local stem cells or secretome injection in total type brachial plexus injuries. This was a double-blinded, randomized controlled study (RCT). We included patients with neglected total type brachial plexus injury (BPI) who underwent nerve transfer and local injection of either umbilical cord-derivedmesenchymal stem cells (UC-MSC) or secretome into median nerve-flexor digitorum superficialis (FDS) neuromuscular junction (NMJ). We measured preoperative and 8-month postoperative FDS muscle strength, SF-36, DASH score, and histologic assessment. We then analyzed the difference outcome between those two groups. A total of 15 patients were included in this study. Our study found that after nerve transfer and implantation with either UC-MSC or secretome, significant postoperative improvements were observed in physical functioning, role limitations, energy/fatigue, emotional well-being, social functioning, pain, general health, and DASH scores, particularly in the overall cohort and the secretome group. When we compared the mean difference of clinical outcome from preoperative to postoperative between UC-MSC and secretome groups, the UC-MSC group showed better improvement of health change in SF-36 subgroup compared to secretome group. From the analysis, there was no significant difference in the histologic outcomes (inflammation, regeneration, and fibrosis) in overall cohort between preoperative and postoperative cohort. There was also no significant difference in mean change of the histologic outcomes (inflammation, regeneration, and fibrosis) preoperative and postoperatively between UC-MSC and secretome groups. Implantation of either UC-MSC or secretome along with nerve transfer may provide clinical improvement, while to achieve histologic improvement, further conditioning should be performed.

Impact of Socio-Demographic Factors on Quality of Life and Coping Strategies of Children with Different Disabilities.

Background and Objectives: Children with disabilities face unique challenges that can affect their well-being and quality of life (QOL). This study aimed to assess the QOL and coping strategies adopted by children with disabilities and explore how socio-demographic factors influence QOL and coping strategies. Materials and Methods: This cross-sectional study, which was conducted in Saudi Arabia with children aged 6 to 18 years, used a stratified random sample to ensure representation from a variety of demographic groups. Short Form-12 (SF-12) was used to assess the QOL in the sample population. The Brief COPE Inventory was used to examine coping strategies among the children. One-way analysis of variance was applied to examine differences in the QOL, coping strategies scores, and demographic variables. Multiple regression analyses were performed to examine the role of demographic variables in predicting QOL and p value was considered statistical significance at p < 0.05. Results: The results of the study clearly revealed significant differences between the mean scores of QOL for gender, age, and type of disability, duration of disability, education qualification, family status, family occupation, and housing status. Female participants showed better QOL in physical functioning than their male counterparts. Children with intellectual disability reported better QOL in general health, vitality, social functioning, and mental health. Participants with seven to eight years of disability reported higher scores in physical functioning, vitality, and mental health. Children whose parents were working in private agencies and living in rented houses scored higher on the general health aspects of quality of life. The findings also revealed that the duration of the disability was a significant predictor of the QOL. The mean scores of different dimensions of coping strategies clearly revealed that male participants used dysfunctional coping (p < 0.01), as compared to problem-focused and emotional-focused coping while female children relied more on emotional-focused coping. Emotion-focused coping was significantly higher in participants with visual (p < 0.01), learning (p < 0.01), and intellectual disabilities (p < 0.01). Dysfunctional coping scores were higher among children with auditory disabilities (p < 0.01) and multiple disabilities (p < 0.01). Conclusions: This study highlights the significance of demographic factors in understanding and improving the well-being of a diverse population of disabled juveniles. It offers valuable insights into the subtle factors affecting quality of life. Future interventions and policies can leverage these findings to enhance the quality of life of individuals with disabilities and to foster a more supportive and inclusive approach.

12571 Ultrasonography Is A Potential Cost-effective Tool To Evaluate Muscle Impairment In Patients With Controlled Cushing’S Disease And Acromegaly

Abstract Disclosure: L. Martel-Duguech: None. H. Bascuñana: None. S. Webb: None. E. Valassi: None. Myopathy is a frequent feature in patients with Cushing’s syndrome (CS) and in patients with acromegaly (ACRO) long-term after biochemical control is achieved. Although ultrasonography (US) is an easy and cost-effective tool to evaluate muscle impairment in the clinical setting, its usefulness in patients with “controlled” ACRO end CS patients has not been established The aim of our study was to evaluate muscle structure using US and assess the correlation between US parameters, muscle function and quality of life (QoL). We included 36 female patients with CS [mean (±SD) age, 50±12 years; mean (±SD) BMI, 26.7±3.8] and 36 age- and BMI-matched healthy women. Mean (±SD) duration of remission was 132±87 months. We also included 36 patients with ACRO [20 females and 16 males, mean (±SD) age, 53±9 years, BMI 27±4 Kg/m2 and duration of control 92±58 months], and 36 age, gender and BMI-matched controls. We obtained transverse ultrasound images of the rectus femoris and assessed muscle intensity at both the midpoint (QmitR) and the distal third (QtercR), between the anterior inferior iliac spine and the proximal end of the patella. We scored muscle intensity using the Heckmatt’s rating scale and classified our findings as follows: 1-normal, 2-mildy increased muscle echoes with normal bone reflection, 3-moderately increased muscle echoes with reduced bone, 4-severely increased muscle echoes with absent bone reflection. We found that mean US intensity score was increased in patients with CS (QmitR p&amp;lt;0.001) and in patients with ACRO (QmitR p&amp;lt;0.05; QtercR p&amp;lt;0.001) vs. the controls, suggesting more impaired muscle architecture in the former, likely due to fibrosis/fatty infiltration. We also measured muscle function using the following tests: gait speed velocity (GS), timed up and go (TUG) and 30-second chair stand. QoL was assessed using both generic (SF-36) and disease-specific (CushingQoL and AcroQoL) questionnaires. US parameters, QoL and muscle function were correlated; in CS patients, higher QtercR was associated with slower GS (r=-0.421, p=0.041) and lower scores in social dimensions on CushingQoL ( friends/family , r=-0.510, p=0.013; and work/study, r=-0.523, p=0.010) . In ACRO patients, higher QmedR was associated with slower GS (r=-0.382, p=0.031) and decreased TUG (r=-0.497, p=0.004) and 30-second chair stand (r=-0.444, p=0.011) in all patients. Higher QmedR was also associated with lower score in physical function (ρ=-0.734, p=0.024), vitality (ρ=-0.728, p=0.026), and AcroQoL total score (ρ=-0.725, p=0.027), in male patients only. Conclusion: muscle US architectural parameters are impaired in “controlled” CS and ACRO patients, and are correlated with muscle function and QoL in both groups of patients. US may be a useful technique to identify, in a clinical setting, those CS and ACRO patients showing residual myopathy. This work was supported by PI17/00749 and PI21/01223 and FEDER funds Presentation: 6/3/2024

Identifying Frailty and Its Risk Factors in Pediatric Patients with Fontan Physiology.

Frailty is a clinical syndrome common in adults with chronic disease with resultant vulnerability to adverse health outcomes. Little is known about frailty in pediatric patients, including those with single-ventricle heart disease. This study aimed to examine the prevalence of frailty and its associated risk factors in patients with Fontan circulation. A single-center, prospective cohort study assessed frailty in patients (10-21years old) after Fontan palliation. Slowness, weakness, exhaustion, shrinkage, and diminished physical activity were evaluated and scored using a modified Fried frailty assessment comprised of validated pediatric tests. Providers estimated subjects' degree of frailty. Patient-reported quality of life (QOL) was assessed. Of 54 participants (median age 15.3years, 61% male), 18 (33%) were identified as frail, while 26 (48%) were pre-frail. Patients frequently exhibited frailty in the domains of slowness (93%), weakness (41%), and diminished physical activity (39%). There was poor correlation between frailty scores and provider estimates of frailty (Kappa = 0.11). Frail subjects had lower PedsQL physical functioning scores (mean 62.8 ± SD 18.5 in Frail vs. 75.7 ± 16.0 in No/pre-Frail; p = 0.01). Factors associated with frailty included protein-losing enteropathy (p = 0.03) and at least one hospitalization in the last year (p = 0.047). One-third of pediatric patients after Fontan palliation were frail which was associated with lower physical functioning and higher healthcare utilization. Providers poorly recognized frailty. These findings highlight the need for improved screening and support for an at-risk population where frailty is not easily identified.

The association of diabetes mellitus and routinely collected patient-reported outcomes in patients with cancer. A real-world cohort study.

Current studies have indicated that diabetes mellitus (DM) is highly prevalent in patients with cancer, but there is little research on consequences on the well-being of patients during cancer treatment. This analysis evaluates the relationship between DM and patient-reported outcomes (PRO) in patients with cancer, using a large and well-characterized cohort. This study utilized the Total Cancer Care protocol at the University of Utah Huntsman Cancer Institute. For this analysis, we integrated data from electronic health records, the Huntsman Cancer Registry, and routinely collected PRO questionnaires. We assessed the association between DM in patients with cancer and PRO scores for anxiety, depression, fatigue, pain interference, and physical function using multiple linear regression and t-tests. The final cohort comprised 3512 patients with cancer, with a mean age of 57.8 years at cancer diagnosis. Of all patients, 49.1% (n = 1724) were female, with 82.0% (n = 2879) patients reporting PROs at least at one time point. Compared with patients who responded, nonresponders were more often female (p = 0.0035), less frequently non-Hispanic White (p = 0.0058), and had a higher BMI (p = 0.0759). Patients with cancer and diabetes had worse PRO scores for anxiety (p = 0.0003), depression (p < 0.0001), fatigue (p < 0.0001), pain interference (p < 0.0001), and physical function (p < 0.0001) compared to patients with cancer without diabetes. Significant associations between diabetes and PRO scores were observed for anxiety (β ± SE: 1.27 ± 0.48; p = 0.0076), depression (β ± SE: 1.46 ± 0.45; p = 0.0011), fatigue (β ± SE: 2.11 ± 0.52; p < 0.0001), pain interference (β ± SE: 1.42 ± 0.50; p = 0.0046), and physical function (β ± SE: -2.74 ± 0.48; p < 0.0001). The results of this study suggest that patients with cancer and diabetes may be at greater risk for anxiety, depression, fatigue, higher pain interference, and reduced physical function. Strengthening diabetes management is imperative to address the negative impact of diabetes on PROs. In particular, this may be true for patients with skin, breast, prostate, and kidney cancer.

Complicated Pleural Infection is Associated With Prolonged Recovery and Reduced Functional Ability.

Management of complicated pleural infections (CPIs) had historically been surgical; however, following the publication of the second multicenter intrapleural sepsis trial (MIST-2), combination tissue plasminogen (tPA) and dornase (DNase) offers a less invasive and effective treatment. Our aim was to assess the quality of life (QOL) and functional ability of patients' recovery from a CPI managed with either intrapleural fibrinolytic therapy (IPFT) or surgery. We identified 565 patients managed for a CPI between January 1, 2013 and March 31, 2018. There were 460 patients eligible for contact, attempted through 2 phone calls and one mailer. Two questionnaires were administered: the Short Form 36-Item Health Survey (SF-36) and a functional ability questionnaire. Contact was made in 35% (159/460) of patients, and 57% (90/159) completed the survey. Patients had lower QOL scores compared to average US citizens; those managed with surgery had higher scores in physical functioning (surgery: 80, IPFT: 70, P=0.040) but lower pain scores (surgery: 58, IPFT: 68, P=0.045). Of 52 patients who returned to work, 48% (25) reported an impact on their work effectiveness during recovery, similarly between management strategies (IPFT: 50%, 13/26 vs. surgery: 46%, 12/26; P=0.781). Patients with a CPI had a lower QOL compared with average US citizens. Surgically managed patients reported improved physical functioning but worse pain compared with patients managed with IPFT. Patients returned to work within 4 weeks of discharge, and nearly half reported their ability to work effectively was impacted by their recovery. With further research into recovery timelines, patients may be appropriately counselled for expectations.

A phase III study to evaluate the long-term safety and efficacy of fasinumab in patients with pain due to osteoarthritis of the knee or hip

BackgroundPain associated with osteoarthritis (OA) is frequently disabling; treatments are often ineffective or intolerable. Fasinumab selectively inhibits nerve-growth factor and has shown efficacy for management of OA pain. MethodsIn this randomized, double-blind, phase III safety study, patients with moderate-to-severe OA pain, and history of inadequate pain relief received placebo or fasinumab (1, 3, 6 and 9 mg every 4 weeks [Q4W]; 1 and 6 mg every 8 weeks [Q8W] for 52 weeks). Primary safety endpoints included adverse events, adjudicated arthropathies (AAs), and joint replacements (JRs). Co-primary endpoints of an efficacy sub-study were change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores. During the study, higher fasinumab doses were discontinued for safety; 1 mg doses continued. ResultsOf 13,945 patients screened, 5331 were randomized; 1074 were included in the efficacy sub-study. AAs and JRs occurred in all groups. Increased severity of disease at baseline was associated with higher rates of AAs and JRs. A dose-dependent risk of AA or JR was observed for fasinumab; in the 1 mg groups, only a small percentage of patients with JR had prior AA. Fasinumab significantly improved WOMAC pain and physical function compared with placebo; least squares mean differences versus placebo for 1 mg Q4W: –1.22 and –1.20 and 1 mg Q8W: –0.73 and –0.74 (P<0.001). ConclusionAAs and JRs showed a dose relationship to fasinumab and were associated with baseline OA status. Fasinumab achieved statistically significant improvements in WOMAC pain and physical function compared with placebo.

Associations between wearable device metrics and performance status in adult patients with cancer.

427 Background: Wearable devices present a promising method for monitoring physical performance in cancer patients, potentially bridging the gap between patient experiences at home and clinical evaluations. This study assesses associations between performance status, home-based wearable device metrics, and patient-reported outcomes (PROs) among adults with cancer. (NCT03952767). Methods: This prospective cohort study enrolled 62 adults undergoing treatment for cancer, irrespective of primary site. Participants wore GENEActiv wrist accelerometer sensors (Activinsights Ltd., Kimbolton, UK) on the lumbar region and non-dominant wrist for 2 weeks, tracking gait speed and activity levels. Patients concurrently completed PRO questionnaires on physical function (PF) and fatigue (PROMIS Fatigue 7a &amp; PROMIS Physical Function 10a). Study participants were stratified by baseline self-reported Karnofsky performance status (KPS; 100, 80-90, &amp; ≤70). Linear regression models were used to assess associations between (1) KPS and device metrics and (2) device metrics and PROs. Covariates included age and a binary indicator for COVID period (pre/post 3/1/2020). Results: Average device wear time across the cohort was 22.2 hours/day. Significant differences in gait speed and moderate activity time were observed between the KPS≤70 group and the higher KPS groups ( Table ). Significant associations were also observed between device metrics and PROs. Each 1-hour increment moderate activity was associated with 5.5 point greater PROMIS PF score (95% CI: 3.3, 7.7; p&lt;0.0001) and 4.6 point lower PROMIS Fatigue score (-6.7, -2.5; p&lt;0.0001). Each 0.1 meter/sec increment in gait speed was associated with 4.6 point greater PF score (95% CI: 2.2, 7.1; p=0.0004) and 4.8 point lower Fatigue score (-6.9, -2.7; p&lt;0.0001). Similar associations were observed between in-clinic assessments of gait speed and physical function scores. Conclusions: The associations between wearable device metrics and KPS indicate that wearable technology is both feasible and reliable for remote health monitoring in cancer patients. The associations between device metrics and PROs demonstrate that these metrics reflect patient experiences and outcomes relevant to both patients and regulatory authorities. The associations with physical function, a key PRO in the FDA’s Patient-Focused Drug Development guidance, are particularly noteworthy. Clinical trial information: NCT03952767 . Group 1(KPS 100) Group 2(KPS 80-90) Group 3(KPS ≤70) p (Group 1 vs 3) p (2 vs 3) Gait Speed (m/s) - adjusted mean, 95% CI 0.74 (0.70, 0.78) 0.72 (0.69, 0.74) 0.65 (0.60, 0.70) 0.0058 0.0210 Sedentary time (hours) 11.2 (9.8, 12.6) 10.2 (9.3, 11.0) 10.7 (9.1, 12.2) 0.5912 0.5647 Light activity (hours) 1.4 (1.0, 1.7) 1.3 (1.1, 1.5) 0.9 (0.5, 1.3) 0.0570 0.0474 Moderate activity (hours) 1.4 (1.0, 1.8) 1.2 (0.9, 1.5) 0.5 (0.0, 1.0) 0.0068 0.0159 Vigorous activity (hours) 0.1 (0.0, 0.2) 0.0 (0.0, 0.1) 0.0 (0.0, 0.1) 0.1201 0.2835

The relationship between patient-reported experience and patient-reported outcomes in patients with cancer.

248 Background: Measures of patient experience (PEX) and patient-reported outcomes (PRO) are used by health systems across the US to improve care delivery and quality of life, respectively. Despite their widespread use, little is known regarding the relationship between these two types of patient-generated data. From 2018 to 2023, we conducted a pragmatic type-II hybrid effectiveness/implementation study of an electronic health record (EHR)-embedded symptom management program (eSyM) across six diverse cancer centers. This project focused on patients who started chemotherapy (CHEMO) or had surgery (SURG) for a suspected or confirmed gastrointestinal, gynecologic, or thoracic malignancy. Methods: We conducted a cross-sectional study of adults who were eligible for either the control or intervention arm of the eSyM study to determine if patients who reported having an inferior care-team experience were more likely to report having worse symptoms. Participants completed a one-time survey via REDCap that included elements from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and the Patient-Reported Outcomes Measurement Information System (PROMIS). Analyses determined the extent to which PEX measures were associated with PRO measures by evaluating differences in mean PROMIS scores for those who rated their PEX highly vs. not highly. Results: In total, 1419 respondents reported having cancer for which they received care at a participating center: median age 66, 63% female, 5% black, 13% disabled, 66% married/partnered, 23% high school or less education, 22% somewhat-extreme difficulty paying bills. For both CHEMO and SURG patients, 82% rated their overall cancer care-team experience highly (top box score of 9-10). Compared to patients who did not rate their care-team experience highly, those who did reported better scores for depression, fatigue, anxiety, pain interference, physical function, and self-efficacy (Table). PROMIS values differed for other CAHPS measures too. Conclusions: Among patients receiving routine cancer care, there was a significant association between PEX and multiple PROs. Further investigation of the nature and strength of the association between PEX and PRO measures is warranted. If confirmed, this association could lead to the development of interventions that impact both patient satisfaction and quality of life. Clinical trial information: NCT03850912 . Mean difference in PROMIS scores for patients who rated their care-team experience highly versus not highly (P from two-sample T-test). CHEMO (N=889) SURG (N=530) Mean Diff 95%CI P value Mean Diff 95%CI P value Depression -2.7 -4.3, -1.1 0.001 -3.3 -5.3, -1.4 &lt;0.001 Anxiety -3.7 -5.4, -1.9 &lt;0.001 -3.6 -5.7, -1.5 &lt;0.001 Fatigue -2.3 -4.0, -0.5 0.011 -4.5 -6.8, -2.2 &lt;0.001 Pain interference -3.6 -5.3, -1.9 &lt;0.001 -4.7 -6.7, -2.7 &lt;0.001 Physical function 1.6 0.1, 3.1 0.042 3.5 1.4, 5.6 0.001 Self-efficacy 3.9 2.6, 5.2 &lt;0.001 6.4 4.6, 8.1 &lt;0.001

Increased Postoperative Deltoid Signal seen after Suprapectoral Biceps Tenodesis: Potential Risk to the Anterior Branch of the Axillary Nerve

BackgroundArthroscopic suprapectoral biceps tenodesis is a common procedure for lesions of the long head of the biceps in the setting of anterior shoulder pain. However, the distal portal poses a theoretical risk to the terminal branches of the axillary nerve as the nerve travels from posterior to anterior to innervate the anterior deltoid. The purpose of this retrospective cohort study was to assess for axillary nerve branch injury, identified by deltoid signal change in postoperative magnetic resonance imaging (MRI) in patients who underwent an arthroscopic suprapectoral biceps tenodesis. MethodsPatients who underwent rotator cuff repair with a concomitant arthroscopic suprapectoral biceps tenodesis, had a postoperative MRI, and at least 1 year of follow-up were included. The incidence of increased deltoid signal consistent with injury to an anterior branch of the axillary nerve on proton density fat saturated sequences was collected. Age, sex, body mass index (BMI), and patient reported outcome measures (PROMs) including the American Shoulder and Elbow Surgeons Shoulder Score (ASES) score, Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function (PF), and upper extremity (UE) scores, and Single Assessment Numeric Evaluation (SANE) score were compared in patients with and without increased deltoid signal on postoperative MRI. P<0.05 was used for significance. ResultsTwenty-four patients were eligible for inclusion (9 female, average age 59.0±10.1, BMI 27.6±6.7). Edema-like signal within the anterior deltoid musculature was observed in 9 patients on postoperative MRI. Two patients had a second follow-up MRI performed which demonstrated resolution of signal, and one patient required a second surgery for release of adhesions. Patients with increased deltoid signal had higher BMI (p=0.03). There was no difference in any other demographic or postoperative PROM between patients with increased signal and those without at any follow-up time point. No patient demonstrated persistent weakness or numbness in the axillary nerve distribution at final follow-up. DiscussionOver one third of patients in our cohort had MRI evidence of axillary nerve branch injury as seen on proton density fat saturated MRI sequences postoperatively. The distal arthroscopic portal for a suprapectoral biceps tenodesis may place anterior terminal branches of the axillary nerve at risk for injury. Additional investigation and strategies for avoidance of nerve injury in this area should be pursued.

Worse Preoperative 12-Item Veterans Rand Physical Component Scores Prognosticate Inferior Outcomes Following Outpatient Lumbar Decompression.

Retrospective Review. Evaluate the influence of the 12-Item veterans Rand (VR-12) physical component score (PCS) on patient-reported outcome measures (PROMs) in an outpatient lumbar decompression (LD) cohort. The influence of baseline VR-12 PCS on postoperative clinical outcomes has not been evaluated in patients undergoing outpatient LD. Patients undergoing primary, elective, 1/2-level outpatient LD with baseline VR-12 PCS scores were retrospectively identified from a prospectively maintained single-surgeon database. Cohorts were preoperative VR-12 PCS<30 and VR-12 PCS≥30. Patient/perioperative characteristics and preoperative/postoperative 6-week/final follow-up (FF) PROMs were collected. Physical health PROMs included the VR-12 PCS, 12-Item Short Form (SF-12) PCS, patient-reported outcome measure information system-physical function (PROMIS-PF), visual analog scale (VAS)-back/leg, and Oswestry disability index (ODI). Mental health PROMs included the VR-12/SF-12 mental component score (MCS) and the patient-health questionnaire-9 (PHQ-9). Average FF was 13.8±8.9 months postoperatively. PROM improvements at 6 weeks/FF and minimal clinically important difference (MCID) achievement rates were determined. χ 2 analysis and the Student's t tests compared demographics, perioperative data, and preoperative PROMs. Multivariate linear/logistic regression compared postoperative PROMs, PROM improvements, and MCID achievement rates. Six weeks postoperatively, VR-12 PCS<30 reported worse baseline PROMs ( P ≤0.042, all) and worse scores except VR-12/SF-12 MCS ( P ≤0.043, all). Compared with VR-12 PCS≥30, VR-12 PCS<30 had worse FF VR-12 PCS, SF-12 PCS/MCS, PROMIS-PF, PHQ-9, and VAS-Back ( P ≤0.033, all). VR-12 PCS<30 experienced greater 6-week improvements in VR-12/SF-12 PCS, PHQ-9, VAS-Back, and ODI ( P ≤0.039, all). VR-12 PCS<30 had greater FF improvements in VR-12/SF-12 PCS, PHQ-9, and ODI ( P ≤0.001, all) and greater overall MCID achievement in VR-12 PCS/MCS, SF-12 PCS, PHQ-9, and ODI ( P ≤0.033, all). VR-12 PCS<30 patients-reported worse baseline/postoperative mental/physical health scores. However, they reported greater improvements in physical function, depressive burden, back pain, and disability by 6 weeks and FF and experienced greater MCID achievement for physical functioning, mental health, and disability scores.