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Keywords = PROMIS-10

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12 pages, 342 KB  
Article
Time and Frequency of Social Media Use and Loneliness Among U.S. Adults
by Jessica R. Gorman, Hyosin Kim, Kari-Lyn K. Sakuma, Geethika Koneru, Memuna Aslam, Cesar Arredondo Abreu and Brian A. Primack
Int. J. Environ. Res. Public Health 2025, 22(10), 1510; https://doi.org/10.3390/ijerph22101510 - 1 Oct 2025
Abstract
The U.S. loneliness epidemic is associated with substantial morbidity and mortality. While higher social media use (SMU) has been associated with higher loneliness among youth, these associations have not been sufficiently examined in adult populations. Additionally, insufficient research has assessed both SMU time [...] Read more.
The U.S. loneliness epidemic is associated with substantial morbidity and mortality. While higher social media use (SMU) has been associated with higher loneliness among youth, these associations have not been sufficiently examined in adult populations. Additionally, insufficient research has assessed both SMU time and frequency in the same study. Therefore, the primary aim was to evaluate associations between SMU, both by time and frequency, and loneliness in a nationally representative sample of U.S. adults. We recruited 1512 U.S. adults ages 30–70 in 2023. We assessed loneliness using the NIH PROMIS four-item scale and self-reported SMU time and SMU frequency. Survey-weighted logistic regression models determined associations between both SMU measures and loneliness, controlling for gender, age, sexual orientation, educational attainment, employment status, and marital status. Both SMU time and SMU frequency were independently and linearly associated with loneliness (p < 0.001 for both). Although odds of loneliness increased for each increase in frequency, the association between time spent on social media and loneliness demonstrated an inverted U-shape with maximal loneliness in the third quartile of SMU. Results suggest that both time and frequency of SMU may be useful targets for interventions aimed at curbing the negative impact of SMU on loneliness. Full article
(This article belongs to the Section Behavioral and Mental Health)
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13 pages, 1326 KB  
Article
A Comparative Study of Quality of Life and Oncologic Outcomes in Premenopausal Women with Hormone Receptor-Positive Breast Cancer: Bilateral Oophorectomy vs. Gonadotropin-Releasing Hormone Agonist Therapy
by Evrim Erdemoglu, Kathryn J. Ruddy, Matthew R. Buras, Jaxon Quillen, Fergus J. Couch, Janet E. Olson, Laura M. Bozzuto, Nicole L. Larson, Johnny Yi and Kristina A. Butler
Cancers 2025, 17(17), 2916; https://doi.org/10.3390/cancers17172916 - 5 Sep 2025
Viewed by 611
Abstract
Background/Objectives: This study aims to evaluate the quality of life (QoL) and oncological outcomes in premenopausal women diagnosed with hormone receptor-positive breast cancer who are receiving either bilateral oophorectomy (BO) or gonadotropin-releasing hormone agonist (GnRH) therapy. Both methods serve to inhibit ovarian function, [...] Read more.
Background/Objectives: This study aims to evaluate the quality of life (QoL) and oncological outcomes in premenopausal women diagnosed with hormone receptor-positive breast cancer who are receiving either bilateral oophorectomy (BO) or gonadotropin-releasing hormone agonist (GnRH) therapy. Both methods serve to inhibit ovarian function, which is essential for the management of estrogen-dependent tumors; however, their effects on QoL have yet to be fully clarified. Methods: Data were analyzed from the Mayo Clinic Breast Disease Registry, focusing on women under 55 diagnosed with estrogen receptor-positive breast cancer who received either BO or GnRH within one year of diagnosis. QoL was assessed using the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) at baseline and annually for five years. Results: A total of 181 patients were enrolled in the study; 40 into the BO group and 141 to the GnRH group. Both groups exhibited similar levels of sexual dysfunction after a one-year period; however, the BO group stated a higher frequency of hot flashes. PROMIS-10 scores improved in both mental and physical health over time, with no significant differences between the groups. Within the BO group, one recurrence was observed, in contrast to the GnRH group, which had six events. Nonetheless, the difference in recurrence rates did not reach statistical significance. Conclusions: The long-term QoL and oncologic outcomes for premenopausal women with hormone receptor-positive breast cancer were similar for BO and GnRH therapy. These findings emphasize the need for individualized treatment decisions, considering patient preferences and side effects. Full article
(This article belongs to the Special Issue Long-Term Cancer Survivors: Rehabilitation and Quality of Life)
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15 pages, 497 KB  
Article
Autonomic Dysfunction in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Findings from the Multi-Site Clinical Assessment of ME/CFS (MCAM) Study in the USA
by Anindita Issa, Jin-Mann S. Lin, Yang Chen, Jacob Attell, Dana Brimmer, Jeanne Bertolli, Benjamin H. Natelson, Charles W. Lapp, Richard N. Podell, Andreas M. Kogelnik, Nancy G. Klimas, Daniel L. Peterson, Lucinda Bateman and Elizabeth R. Unger
J. Clin. Med. 2025, 14(17), 6269; https://doi.org/10.3390/jcm14176269 - 5 Sep 2025
Viewed by 4946
Abstract
Background/Objectives: Symptoms of autonomic dysfunction are common in infection-associated chronic conditions and illnesses (IACCIs), including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This study aimed to evaluate autonomic symptoms and their impact on ME/CFS illness severity. Methods: Data came from a multi-site study [...] Read more.
Background/Objectives: Symptoms of autonomic dysfunction are common in infection-associated chronic conditions and illnesses (IACCIs), including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This study aimed to evaluate autonomic symptoms and their impact on ME/CFS illness severity. Methods: Data came from a multi-site study conducted in seven ME/CFS specialty clinics during 2012–2020. Autonomic dysfunction was assessed using the Composite Autonomic Symptom Scale 31 (COMPASS-31), medical history, and a lean test originally described by the National Aeronautics and Space Administration (NASA). Illness severity was assessed using Patient-Reported Outcomes Measurement Information System measures, the 36-item short-form, as well as the CDC Symptom Inventory. This analysis included 442 participants who completed the baseline COMPASS-31 assessment, comprising 301 individuals with ME/CFS and 141 healthy controls (HC). Results: ME/CFS participants reported higher autonomic symptom burden than HC across three assessment tools (all p < 0.0001), including the COMPASS-31 total score (34.1 vs. 6.8) and medical history indicators [dizziness or vertigo (42.6% vs. 2.8%), cold extremities (38.6% vs. 5.7%), and orthostatic intolerance (OI, 33.9% vs. 0.7%)]. Among ME/CFS participants, 97% had at least one autonomic symptom. Those with symptoms in the OI, gastrointestinal, and pupillomotor domains had significantly higher illness severity than those without these symptoms. Conclusions: ME/CFS patients exhibit a substantial autonomic symptom burden that correlates with greater illness severity. Individualized care strategies targeting dysautonomia assessment and intervention may offer meaningful improvements in symptom management and quality of life for those with ME/CFS and similar chronic conditions. Full article
(This article belongs to the Special Issue POTS, ME/CFS and Long COVID: Recent Advances and Future Direction)
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15 pages, 2455 KB  
Article
Mechanistic Insights into a Self-Management Intervention in Young Adults with Irritable Bowel Syndrome: A Pilot Multi-Omics Study
by Weizi Wu, Jie Chen, Aolan Li, Ming-Hui Chen, Angela Starkweather and Xiaomei Cong
Biomedicines 2025, 13(9), 2102; https://doi.org/10.3390/biomedicines13092102 - 28 Aug 2025
Viewed by 473
Abstract
Background: Self-directed lifestyle modifications are essential for managing symptoms in individuals diagnosed with irritable bowel syndrome (IBS). This study incorporated longitudinal multi-omics profiling to estimate the mechanisms underlying responses to a nurse-led person-centered self-management intervention in young adults with IBS. Methods: This pre-post [...] Read more.
Background: Self-directed lifestyle modifications are essential for managing symptoms in individuals diagnosed with irritable bowel syndrome (IBS). This study incorporated longitudinal multi-omics profiling to estimate the mechanisms underlying responses to a nurse-led person-centered self-management intervention in young adults with IBS. Methods: This pre-post study was nested within a 12-week parent randomized controlled trial (NCT03332537). Biospecimens (stool and blood) and clinical outcomes were collected at baseline and post-intervention. Symptoms were assessed using the Brief Pain Inventory and PROMIS® short forms. Host transcriptomic profiling was performed using RNA sequencing, and gut microbial composition was analyzed via 16S rRNA sequencing. Host transcriptomic co-expression and microbial co-abundance modules were identified via weighted gene co-expression network analysis. Associations between multi-omics modules and symptoms were evaluated using linear mixed-effect models. Results: Among the 20 participants, most were non-Hispanic (75%), White (75%), and female (65%). The intervention significantly reduced self-reported pain severity (p = 0.019) and pain interference (p = 0.013). Decreased associations were observed between pain phenotypes and a microbial module enriched in core metabolic pathways (interference: β = −4.7, p < 0.001; severity: β = −2.4, p = 0.02). Anxiety strengthened associations with host transcriptomic cellular energy metabolism pathways post-intervention (p < 0.05). The intervention attenuated associations between fatigue, sleep disturbance, and immune–inflammatory transcriptomic and microbial adaptation modules (p < 0.05). Conclusions: Findings suggest that the IBS self-management intervention induces symptom-specific biological responses, implicating distinct host–microbe pathways. Larger longitudinal studies are warranted to validate these omics-based symptom signatures. Full article
(This article belongs to the Special Issue Cellular and Molecular Mechanisms in Gastrointestinal Tract Disease)
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10 pages, 237 KB  
Article
Clinical Setting Does Not Impact Baseline Patient Reported Outcomes Measures in Patients Undergoing Anterior Cervical Diskectomy and Fusion: A Prospective Study
by Rohan Gopinath, Rohan I. Suresh, Hershil Patel, Ivan B. Ye, Alexandra E. Thomson, Jacob Bruckner, Julio J. Jauregui, Ali A. Aneizi, Louis J. Bivona, Daniel L. Cavanaugh, Eugene Y. Koh, R. Frank Henn, Daniel Gelb and Steven C. Ludwig
J. Clin. Med. 2025, 14(16), 5852; https://doi.org/10.3390/jcm14165852 - 19 Aug 2025
Viewed by 457
Abstract
Background/Objectives: Patient-reported outcome measures (PROMs) are widely used tools in orthopedic surgery for evaluating clinical outcomes, guiding research, and supporting value-based care. However, the optimal timing for collecting baseline PROMs, whether in clinic prior to surgery or on the day of surgery, [...] Read more.
Background/Objectives: Patient-reported outcome measures (PROMs) are widely used tools in orthopedic surgery for evaluating clinical outcomes, guiding research, and supporting value-based care. However, the optimal timing for collecting baseline PROMs, whether in clinic prior to surgery or on the day of surgery, remains uncertain. This study investigated whether the clinical setting (preoperative clinic vs. day of surgery) affects baseline PROMs in patients undergoing anterior cervical discectomy and fusion (ACDF). Methods: Patients undergoing elective, primary ACDF at a single institution between August 2019 and June 2021 were prospectively enrolled. Inclusion criteria included age over 18, English literacy, and eligibility for primary ACDF. Participants completed PROMIS domains, Neck Disability Index (NDI), Modified Japanese Orthopaedic Association (mJOA) score, and Visual Analog Scale (VAS) at two time points: during the preoperative clinic visit and again in the perioperative area on the day of surgery. A subgroup analysis was performed for patients with anxiety, defined as a PROMIS anxiety score ≥ 59.4. Results: A total of 63 patients were enrolled, with 48 completing both sets of surveys. The average time between the two assessments was 7.9 days (95% CI: 6.4–9.3). After Bonferroni correction (α = 0.005), no significant differences were observed in any PROMs across the two time points, including PROMIS physical function (p = 0.398), pain interference (p = 0.682), fatigue (p = 0.019), social satisfaction (p = 0.331), anxiety (p = 0.047), depression (p = 0.042), NDI (p = 0.072), mJOA (p = 0.566), VAS neck pain (p = 0.054), or VAS overall pain (p = 0.335). Subgroup analysis of anxious patients similarly revealed no statistically significant changes between settings. Conclusions: PROM scores were not meaningfully different between the preoperative clinic and the day of surgery in patients undergoing ACDF. These results are most applicable when baseline PROMs are collected within about one week of ACDF. These findings support flexibility in workflow design for PROM collection, as the timing and setting do not significantly impact baseline responses. Full article
(This article belongs to the Special Issue Orthopedic Surgery: Latest Advances and Future Prospects)
16 pages, 829 KB  
Article
Evaluating the Efficacy of a Novel Titanium Cage System in ALIF and LLIF: A Retrospective Clinical and Radiographic Analysis
by Ryan W. Turlip, Mert Marcel Dagli, Richard J. Chung, Daksh Chauhan, Richelle J. Kim, Julia Kincaid, Hasan S. Ahmad, Yohannes Ghenbot and Jang Won Yoon
J. Clin. Med. 2025, 14(16), 5814; https://doi.org/10.3390/jcm14165814 - 17 Aug 2025
Viewed by 625
Abstract
Background/Objectives: The success of lumbar interbody fusion depends on the implant design and the surgical approach used. This study evaluated the clinical and radiographic outcomes of lateral lumbar interbody fusion (LLIF) and anterior lumbar interbody fusion (ALIF) using a 3D-printed porous titanium [...] Read more.
Background/Objectives: The success of lumbar interbody fusion depends on the implant design and the surgical approach used. This study evaluated the clinical and radiographic outcomes of lateral lumbar interbody fusion (LLIF) and anterior lumbar interbody fusion (ALIF) using a 3D-printed porous titanium interbody cage system. Methods: A retrospective, single-center review of 48 patients treated for degenerative lumbar spine disease was conducted. Patients underwent LLIF, ALIF, or a combination of both using a 3D-printed titanium cage system (J&J MedTech, Raynham, MA, USA). The Oswestry disability index (ODI) and Patient-Reported Outcomes Measurement Information System (PROMIS) metrics were assessed after 6 weeks, 3 months, 6 months, and 12 months. Linear mixed-effects models evaluated the pre- and post-operative differences. Fusion performance and complications were assessed using the Bridwell grading system over 24 months. Results: A total of 78 levels (62 LLIF and 16 ALIF) were analyzed. Fusion rates were 90.3% (56/62) for LLIF levels and 81.3% (13/16) for ALIF levels by the end of 12 months. ODI scores improved significantly after 3 months (MD −13.0, p < 0.001), 6 months (MD −12.3, p < 0.001), and 12 months (MD −14.9, p < 0.001). PROMIS Pain Interference scores improved after 3 months (MD −6.1, p < 0.001), 6 months (MD −3.4, p < 0.001), and 12 months (MD −5.8, p < 0.001). PROMIS Physical Function scores improved after 3 months (MD +3.4, p = 0.032) and 12 months (MD +4.9, p < 0.001). Conclusions: This novel interbody cage demonstrated high fusion rates, significant pain and function improvements, and a favorable safety profile, warranting further comparative studies. Full article
(This article belongs to the Special Issue Clinical Advances in Spinal Neurosurgery)
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17 pages, 302 KB  
Article
Validity of PROMIS® Pediatric Physical Activity Parent Proxy Short Form Scale as a Physical Activity Measure for Children with Cerebral Palsy Who Are Non-Ambulatory
by Nia Toomer-Mensah, Margaret O’Neil and Lori Quinn
Behav. Sci. 2025, 15(8), 1042; https://doi.org/10.3390/bs15081042 - 31 Jul 2025
Viewed by 590
Abstract
Background: Self-report physical activity (PA) scales, accelerometry, and heart rate (HR) monitoring are reliable tools for PA measurement for children with cerebral palsy (CP); however, there are limitations for those who are primary wheelchair users. The purpose of our study was to [...] Read more.
Background: Self-report physical activity (PA) scales, accelerometry, and heart rate (HR) monitoring are reliable tools for PA measurement for children with cerebral palsy (CP); however, there are limitations for those who are primary wheelchair users. The purpose of our study was to evaluate face and construct validity of the PROMIS® Pediatric PA parent proxy short form 8a in measuring PA amount and intensity in children with CP who are non-ambulatory. Methods: Face validity: Semi-structured interviews with parents and pediatric physical therapists (PTs) were conducted about the appropriateness of each item on the PROMIS® Pediatric PA short form. Construct validity: Children with CP who were non-ambulatory participated in a one-week observational study. PA amount and intensity were examined using PA monitors (Actigraph GT9X) and HR monitors (Fitbit Charge 4). Activity counts and time in sedentary and non-sedentary intensity zones were derived and compared to the PROMIS® T-scaled score. Results: Twenty-two physical therapists (PTs) and fifteen parents participated in the interviews, and ten children completed 1-week PA observation. Eight and seven participants completed sufficient time of uninterrupted PA and HR monitor wear, respectively. Parents and PTs agreed that several questions were not appropriate for children with CP who were non-ambulatory. PA intensity via activity counts derived from wrist worn monitors showed a strong positive correlation with the PROMIS® PA measure. Conclusions: Construct validity in our small sample was established between PROMIS® scores and accelerometry activity counts when documenting PA amount and intensity; however, there were some differences on PROMIS® face validity per parent and PT respondents. Despite some concerns regarding face validity, the PROMIS® Pediatric PA parent proxy short form 8a shows promise as a valid measure of physical activity amount and intensity in non-ambulatory children with CP, warranting further investigation and refinement. Full article
15 pages, 240 KB  
Article
Exploring Pediatric Perspectives on Crohn’s Disease: A Qualitative Study of Knowledge, Lived Experience, and Self-Management
by Sara Azevedo, Luís Rodrigues and Ana Isabel Lopes
Healthcare 2025, 13(14), 1710; https://doi.org/10.3390/healthcare13141710 - 16 Jul 2025
Viewed by 591
Abstract
Background: Pediatric Crohn’s Disease (CD) affects more than physical health, influencing emotional well-being, social integration, and developmental milestones, with an impact on disease management. This study aimed to explore adolescents’ lived experiences with CD and identify factors influencing their motivation for self-management. Methods: [...] Read more.
Background: Pediatric Crohn’s Disease (CD) affects more than physical health, influencing emotional well-being, social integration, and developmental milestones, with an impact on disease management. This study aimed to explore adolescents’ lived experiences with CD and identify factors influencing their motivation for self-management. Methods: A descriptive, cross-sectional qualitative study was conducted using a semi-structured, self-administered online questionnaire. Participants (n = 10) were adolescents with CD who had been diagnosed for over three years and were recruited from a tertiary pediatric gastroenterology center. Data included demographics, clinical characteristics, IMPACT-III (HRQOL), and PROMIS short forms. Open-ended responses underwent thematic analysis using the framework developed by Braun and Clarke. Results: Participants (80% female, median age 16.2 years, median disease duration 4.6 years) were all in clinical remission (median PCDAI = 2) and with good quality of life (median IMPACT-III = 80.7). Six themes emerged: (1) disease knowledge, (2) emotional responses, (3) coping and adaptation, (4) social support, (5) daily life and school impact, and (6) transition to adult care. Most participants demonstrated strong disease literacy and reported effective coping strategies. Emotional responses to diagnosis ranged from relief (60%) to distress (40%); relapses commonly triggered anxiety and fear. Therapeutic changes and disease monitoring were perceived as beneficial (100%) but with concern. Diagnostic procedures were viewed as burdensome by 70% of respondents. School performance and extracurricular participation were negatively affected in 40% during flares. Concerns regarding the future were reported by 40% of participants, with 30% believing that CD might limit life aspirations. While 60% managed their disease independently, 30% relied on parental support. All acknowledged the need for transition to adult care, though readiness varied. Conclusions: This study illustrates the overall impact of disease on pediatric CD patients. It reports significant emotional challenges and difficulties, as well as an impact on daily life, despite good disease knowledge. The findings underscore the importance of psychosocial well-being, ongoing mental health assessment, non-invasive monitoring, and holistic care, emphasizing the patient perspective, in managing pediatric CD. Full article
14 pages, 241 KB  
Article
Anxiety and Depressive Symptoms Post-COVID-19 Pandemic Onset in Solid Organ Transplant Recipients: Canadian Repeated Cross-Sectional Study
by Jad Fadlallah, Vishva Shah, Ana Samudio, Tom Blydt-Hansen and Istvan Mucsi
J. Clin. Med. 2025, 14(14), 4920; https://doi.org/10.3390/jcm14144920 - 11 Jul 2025
Viewed by 637
Abstract
Background: Solid Organ Transplant Recipients (SOTRs) face an elevated risk of Sars-CoV-2 infection and poor outcomes if they contract the infection. This can induce or exacerbate anxiety and depressive symptoms. We used the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (A) and Depression [...] Read more.
Background: Solid Organ Transplant Recipients (SOTRs) face an elevated risk of Sars-CoV-2 infection and poor outcomes if they contract the infection. This can induce or exacerbate anxiety and depressive symptoms. We used the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (A) and Depression (D) scores to conduct a repeated cross-sectional (“pseudo-longitudinal”) comparison of SOTRs’ anxiety and depressive symptoms before and after the COVID-19 pandemic onset. Methods: This secondary analysis used cross-sectional data from a convenience sample of adult SOTRs (kidney, kidney–pancreas, and liver) recruited between 2016 and 2024. The exposure was categorized as follows: “Pandemic Experience” was categorized as PRE (pre-pandemic reference; transplanted and anxiety and depressive symptoms assessed pre-pandemic onset), POST-1 (transplanted before and assessed after onset), and POST-2 (transplanted and assessed after onset). The outcomes were PROMIS-A and PROMIS-D scores. The differences were assessed using multivariable linear regression-estimated means. Results: Of the 816 participants, 588 (72%) were PRE, 135 (17%) were POST-1, and 93 (11%) were POST-2. In the fully adjusted model, the POST-2 group had significantly higher PROMIS-A scores (more severe symptoms) compared with PRE (adjusted mean [95% CI]: 54.2 [52.3; 56.1] vs. 51.7 [50.9; 52.4], p = 0.02). The proportion of patients with potentially clinically significant anxiety was also higher in the POST-2 group, compared with PRE (OR [95%CI] 1.59 [1.0; 2.5]). The PROMIS-A scores were similar between PRE and POST-1, and between POST-1 and POST-2. The PROMIS-D scores were not different across the exposure groups. Conclusions: SOTRs transplanted after the pandemic onset experienced more anxiety but similar depression symptoms compared with pre-pandemic levels. Future research should explore mental health support for SOTRs during crisis situations involving infectious risk. Full article
(This article belongs to the Section Mental Health)
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18 pages, 1546 KB  
Article
Effects of Pre-Operative HbA1c on Outcomes and the Rate of Clinical Improvement Following Anterior Cervical Discectomy and Fusion
by Ara Khoylyan, Noah Coleman, Matthew Parry, Alex Tang and Tan Chen
J. Clin. Med. 2025, 14(13), 4589; https://doi.org/10.3390/jcm14134589 - 28 Jun 2025
Viewed by 793
Abstract
Retrospective Cohort Study. Objectives: The objectives of this study are to (1) compare post-operative patient-reported outcome measures (PROMs) between non-diabetic (non-DM) and diabetic (DM) patients undergoing Anterior Cervical Discectomy and Fusion (ADCF), (2) characterize the clinical trajectory, and (3) compare the rate of [...] Read more.
Retrospective Cohort Study. Objectives: The objectives of this study are to (1) compare post-operative patient-reported outcome measures (PROMs) between non-diabetic (non-DM) and diabetic (DM) patients undergoing Anterior Cervical Discectomy and Fusion (ADCF), (2) characterize the clinical trajectory, and (3) compare the rate of post-operative complications. Methods: A total of 261 non-DM and 52 DM patients were included. Patient demographics, Neck Disability Index (NDI) and Patient-Recorded Outcomes Measurement Information System (PROMIS) scores were collected up to one year after operation. Maximum medical improvement (MMI) was defined as the timepoint where more than 90% of the cohort achieved a minimal clinically important difference (MCID) in survey scores. Post-operative complications were collected. Descriptive and inferential statistics were performed. Results: Non-DM patients achieve MMI significantly more quickly than DM patients (non-DM: 6 months; DM: 1 year, p < 0.010). No difference in ∆NDI (non-DM: 24.9; DM: 23.0; p = 0.824) or ∆PROMIS-Physical Function (non-DM: 7.1; DM: 9.1; p = 0.373) was found between the two cohorts. In diabetic patients undergoing single-level fusion ACDF, a pre-operative HbA1c of ≥7.3% demonstrates 100% sensitivity and 25% specificity in detecting failure to achieve 1-year PROMIS MCID (AUC = 0.833, p = 0.009). There was no association between diabetic status and post-operative complication rate. Conclusions: Diabetic patients may demonstrate a slower rate of achieving maximum medical improvement despite equal subjective and clinical outcomes. Pre-operative HbA1c ≥ 7.3% demonstrates a significant correlation with worse subjective outcomes following single-level ACDF. Full article
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13 pages, 1810 KB  
Article
A Randomized, Placebo-Controlled, Double-Blind Trial to Assess the Effects of Apocynum venetum L. (A. venetum) Venetron® on Sleep and Stress in Those Expressing Feelings of Anxiety
by Kaitlyn P. White, Susan Hewlings, Corey Bryant, Megan Moseley, Christopher R. D’Adamo, Christopher S. Colwell, Jeff Chen and Emily K. Pauli
Int. J. Transl. Med. 2025, 5(2), 23; https://doi.org/10.3390/ijtm5020023 - 13 Jun 2025
Viewed by 2166
Abstract
Background/Objectives: Anxiety and stress are interrelated and connected to reduced health-related quality of life. Botanicals such as Apocynum venetum L. (A. venetum) have been shown to improve health outcomes. No human studies have been conducted in a diverse large group of [...] Read more.
Background/Objectives: Anxiety and stress are interrelated and connected to reduced health-related quality of life. Botanicals such as Apocynum venetum L. (A. venetum) have been shown to improve health outcomes. No human studies have been conducted in a diverse large group of healthy adults in the US. The purpose of this randomized, double-blind, placebo-controlled study was to evaluate the effects of Venetron® Rafuma (A. venetum leaf extract) on self-reported anxiety levels and overall health outcomes compared to placebo. Methods: Healthy adults (N = 476) seeking improvement in self-reported anxiety and stress were randomly assigned to receive 50 mg of A. venetum (n = 234) or placebo (n = 242) for 6 weeks. Feelings of anxiety were assessed at baseline and weekly using Patient-Reported Outcomes Measurement Information System (PROMIS™) Anxiety 8A. Perceived stress, sleep quality, and cognitive function were evaluated at baseline and weekly using validated assessments. A linear mixed-effects regression model was used to compare the change in health outcome scores between active and placebo groups. Results: A total of 370 participants completed at least one additional assessment and were included in the analysis: 179 in the active arm and 191 in the placebo arm. There was a significant difference between the groups in the rate of improvement in perceived stress and sleep disturbance. The active group was significantly more likely to experience a Minimal Clinically Important Difference (MCID) in their perceived stress and marginally significantly more likely to experience an MCID in their feelings of anxiety. Participants who reported experiencing side effects did not significantly differ between arms. Conclusions: Venetron® may be safe and effective therapy for stress and sleep disturbance among those suffering from feelings of anxiety. Full article
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12 pages, 1225 KB  
Article
Characterization of Tiered Psychological Distress Phenotypes in an Orthopaedic Sports Population
by Billy I. Kim, Nicholas J. Morriss, Taylor P. Stauffer, Julia E. Ralph, Caroline N. Park, Trevor A. Lentz and Brian C. Lau
Int. J. Environ. Res. Public Health 2025, 22(6), 914; https://doi.org/10.3390/ijerph22060914 - 9 Jun 2025
Viewed by 551
Abstract
Psychological distress and musculoskeletal pain are interconnected with poor functional outcomes. This study sought to classify common phenotypes of psychological distress in an orthopaedic sports population and assess differences in functional outcomes using the Prediction of Referral and Outcome (OSPRO-YF) tool. This was [...] Read more.
Psychological distress and musculoskeletal pain are interconnected with poor functional outcomes. This study sought to classify common phenotypes of psychological distress in an orthopaedic sports population and assess differences in functional outcomes using the Prediction of Referral and Outcome (OSPRO-YF) tool. This was a cross-sectional study on 411 operative patients from a single sports surgeon’s clinical practice with completed OSPRO-YF questionnaires. Latent class analysis was employed to construct distress phenotypes based on binary measures for 11 single-construct psychological questionnaires, spanning two negative and one positive domains of pain-associated psychological distress. Functional outcome measures, including numerical pain scores, the Patient-Reported Outcomes Measurement Information System (PROMIS), the Single Assessment Numeric Evaluation (SANE) American Shoulder and Elbow Surgeons Score (ASES), and the International Knee Documentation Committee Subjective Knee Form (IKDC), were compared. Four psychological distress clusters were derived: low distress (LD-1; n = 111), low self-efficacy (LS-2; n = 101), negative pain coping, low self-efficacy (NP-3; n = 99), and high distress (HD-4; n = 100), with increasing yellow flags proceeding from LD-1 to HD-4. The mean numerical pain scores were highest in HD-4 and lowest in LD-1 and LS-2 (4.6 vs. 2.7 and 2.0, respectively; p < 0.001). The PROMIS depression scores were highest in HD-4 compared to NP-3, LS-2, and LD-1 (57.0 vs. 48.9 vs. 45.6 vs. 46.0; p < 0.001). Phenotyping patients based on OSPRO-YF distress indicators provides an initial framework of the psychological distress burdening the average orthopaedic sports surgical patient population and may aid in targeted psychological treatments. Full article
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11 pages, 238 KB  
Article
The Impact of a 3-Month Behavioral Weight Loss Intervention on Psychological Flexibility and Depression
by Samantha J. Schram and Jason Lillis
Behav. Sci. 2025, 15(6), 788; https://doi.org/10.3390/bs15060788 - 7 Jun 2025
Viewed by 756
Abstract
A significant portion of individuals with overweight or obesity seek behavioral weight loss, which aims to modify behaviors and habits related to diet, physical activity, and lifestyle and has been shown to result in clinically meaningful weight loss and improved cardiometabolic health. While [...] Read more.
A significant portion of individuals with overweight or obesity seek behavioral weight loss, which aims to modify behaviors and habits related to diet, physical activity, and lifestyle and has been shown to result in clinically meaningful weight loss and improved cardiometabolic health. While the physical outcomes of behavioral weight loss are well documented, relevant psychological processes and mental health outcomes are less studied. This secondary analysis examined psychological flexibility in relation to depression change and weight change in adults (N = 508) with a body mass index greater than 25 enrolled in a 3-month automated behavioral weight loss intervention. Psychological flexibility was assessed using the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT), a tool based on Acceptance and Commitment Therapy (ACT) principles. The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative Depression-Short Form, which collects information directly reported by patients, was used to measure levels of depression. Change in psychological flexibility was found to significantly moderate the positive relationship between weight change and change in depression over the course of a 3-month behavioral weight loss intervention, such that individuals with greater increases in psychological flexibility experienced greater reductions in depression levels when also losing weight. These results suggest that psychological flexibility may enhance the psychological benefits of behavioral weight loss and could be a useful target in a modified version of behavioral weight loss intervention. Full article
(This article belongs to the Special Issue Psychological Flexibility for Health and Wellbeing)
14 pages, 2103 KB  
Case Report
Patient-Reported Outcomes with Peripheral Nerve Stimulation for Low Back Pain from Vertebral Plana Deformities: A Case Series
by Saba Javed, Loc Lam, Angela Nwankwo and Zaur Komachkov
J. Clin. Med. 2025, 14(11), 3964; https://doi.org/10.3390/jcm14113964 - 4 Jun 2025
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Abstract
Objectives: This study evaluated peripheral nerve stimulation (PNS) as a treatment for vertebra plana fractures, focusing on its impact on pain intensity, physical function, anxiety, depression, fatigue, social role participation, and pain interference. The goal was to assess whether PNS could serve as [...] Read more.
Objectives: This study evaluated peripheral nerve stimulation (PNS) as a treatment for vertebra plana fractures, focusing on its impact on pain intensity, physical function, anxiety, depression, fatigue, social role participation, and pain interference. The goal was to assess whether PNS could serve as a minimally invasive alternative for managing pain in patients with severe vertebral fractures. Methods: Four patients with lumbar vertebra plana fractures received PNS implants for 60 days. Pain scores and PROMIS-29 domains (physical function, anxiety, depression, fatigue, social participation, and pain interference) were assessed at 30, 60, 90, 180, and 365 days post-implantation. Data analysis included mean and standard deviation calculations. Results: PNS led to marked improvements in pain-related outcomes. The average pain intensity scores dropped from 8.5 at baseline to 4.25 at one year, and pain interference scores declined from 61.75 to 54.75. Physical function initially decreased but improved from 38.5 at three months to 46.75 at one year. Changes in depression, anxiety, fatigue, and social participation were minimal, reflecting their multifactorial nature and limited response to pain relief alone. Conclusions: This case series suggests that PNS may significantly reduce pain and pain interference while enhancing physical function in patients with vertebra plana fractures. Its sustained benefits highlight PNS as a promising minimally invasive treatment, especially for those ineligible for traditional procedures. However, the limited improvement in psychological and social domains underscores the need for comprehensive care strategies. Further research is warranted to explore the broader role of PNS in managing vertebral fracture pain. Full article
(This article belongs to the Special Issue Clinical Advances in Pain Management)
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11 pages, 379 KB  
Article
The Design of a Patient-Centered Hierarchal Composite Outcome for a Multi-Center Randomized Controlled Trial in Metastatic Bone Disease
by Hadia Farrukh, Abbey Kunzli, Olivia Virag, Nathan O’Hara, Sheila Sprague, Amy Cizik, Ricardo Gehrke-Becker, Thomas Schubert and Michelle Ghert
Curr. Oncol. 2025, 32(6), 318; https://doi.org/10.3390/curroncol32060318 - 30 May 2025
Cited by 1 | Viewed by 581
Abstract
The proximal femur represents the most frequent site in the appendicular skeleton for metastatic bone disease (MBD) to occur, with a high risk for pathologic fracture. While surgical stabilization is typically used to manage fractures, reconstruction approaches are gaining popularity due to improved [...] Read more.
The proximal femur represents the most frequent site in the appendicular skeleton for metastatic bone disease (MBD) to occur, with a high risk for pathologic fracture. While surgical stabilization is typically used to manage fractures, reconstruction approaches are gaining popularity due to improved survival. Previous studies have focused on clinical outcomes, but patient-centered outcomes remain underexplored. This study aims to develop a patient-centered primary outcome for the Proximal FEmur Reconstruction or Internal Fixation fOR Metastases (PERFORM) Randomized Controlled Trial, employing a mixed-methods approach. First, a focus group with advanced cancer patients and caregivers identified relevant outcomes. Next, a discrete choice experiment (DCE) assessed the importance of these outcomes among stakeholders, including surgeons, patients and caregivers. The most important components for the primary outcome were identified: mortality within twelve months, physical function assessed at four months using the PROMIS® Global Physical Function score, and the number of days at home within twelve months. The DCE further confirmed that survival and physical function were most prioritized. The PERFORM trial’s primary outcome, developed through extensive stakeholder engagement, will guide the evaluation of surgical approaches for MBD of the proximal femur and has the potential to influence patient-centered practice. Full article
(This article belongs to the Section Bone and Soft Tissue Oncology)
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