Citations

Abstract Regenerative medicine is a rapidly advancing field, particularly within the field of physical medicine and rehabilitation. While orthobiologics are currently being used in clinical practice, there remains a need for high-quality clinical trials and translational research to standardize treatments and improve patient outcomes. Education is vital for streamlining development of evidence-based, practical, and effective treatments. In this article, we highlight the need for a 1-yr advanced fellowship in translational orthobiologics aiming to create a standardized core curriculum targeting physicians involved in treating musculoskeletal diseases. The fellowship’s objectives include advancing translational orthobiologics research, ethical considerations, and promoting effective communication regarding orthobiologic therapies. Such a program would serve as a foundation for physicians interested in conducting clinically oriented orthobiologics research for musculoskeletal disorders while improving the development of safe and effective therapeutics related to musculoskeletal disorders.

PURPOSE Many trials ask patients to complete patient-reported outcome measures (PROMs) via the web, excluding patients unable to use/access the Internet. The PRO-TECT trial (AFT-39, ClinicalTrials.gov identifier: NCT03249090 ) also offered a telephone interface option (interactive voice response [IVR]). We compared patients choosing IVR versus web on alert rates to nurses and clinical outcomes to determine if a telephone option can close disparities in symptom management. METHODS PRO-TECT randomized 26 community oncology practices to the PROM intervention arm where concerning symptoms generated automated alerts to nurses. IVR and web patients were compared for social determinants of health (SDOH) using analysis of variance and chi-square tests. After accounting for clustering and confounders, we used generalized estimating equations to compare alert rates, mixed models for quality of life (QOL) at 3 months, and Cox regression for emergency visits and survival at 12 months. RESULTS Among 593 patients, 215 (36%) chose IVR and 378 (64%) chose web. IVR patients were older (65.2 v 60.8 years) and were more often rural residents (32% v 23%), Black (27% v 11%), and with less education (54% v 27% ≤high school; all P < .01). Patients choosing IVR had more surveys with concerning symptoms (49% v 37%) and nurses felt clinical attention was warranted more often (4.8 surveys v 3.4 surveys; all P < .001) but ultimately experienced similar benefits as web in QOL, emergency visits, and survival. CONCLUSION One third of community patients choose a telephone option over the web for reporting PROMs during cancer care. These patients are disproportionately from SDOH backgrounds at risk of poor clinical outcomes and have higher symptom management needs but ultimately experience similar clinical benefits as patients choosing the web. PROM programs should offer web alternatives to close disparities in symptom management.

Heart transplantation is a well-established treatment for end-stage heart failure, but many patients present in poor physical condition, complicating outcomes. The Impella 5.5 device, used in cardiogenic shock, may support pretransplant rehabilitation by stabilizing organ function and promoting functional improvement. This retrospective cohort study assessed the relationship between functional status, measured by standardized Activity Measure for Post-Acute Care Basic Mobility (AM-PAC) scores, and days alive outside the hospital within 30 days post-transplant (DAOH-30). Patients who received Impella 5.5 support before transplantation between January 2019 and October 2023 were included, excluding those without AM-PAC scores within 24 hours pretransplant. Among 65 patients, the median DAOH-30 was 15 days (interquartile range [IQR], 8–19). Higher pretransplant standardized AM-PAC scores correlate with increased DAOH-30 (adjusted coefficient 0.3; 95% confidence interval [CI] = 0.01–0.6; p = 0.04), as did AM-PAC score improvement during rehabilitation (adjusted coefficient 0.35; 95% CI = 0.01–0.6; p = 0.04). Extended rehabilitation was associated with greater functional gains. These findings suggest that better pretransplant functional status and rehabilitation-related improvements were associated with increased DAOH-30. The Impella 5.5 device facilitates rehabilitation and may enhance post-transplant outcomes. Further research should refine strategies to optimize rehabilitation and recovery in this high-risk population.

Abstract Objectives To compare the efficacy and safety of antibiotic lock therapy (ALT) versus catheter removal in managing central vascular catheter–associated bloodstream infection (CVC-BSI). Methods We conducted a single-centre, retrospective cohort study of adult patients treated with ALT or catheter removal for management of CVC-BSI between 2018 and 2022. The primary outcome was a composite of 90 day microbiological relapse or recurrent BSI. Secondary outcomes included 30 day mortality, CVC-associated complications and Clostridioides difficile infection (CDI). Logistic regression with propensity score-adjustment was used to evaluate differences in outcomes and identify predictors of relapse. Results During the study period, 106 participants received ALT and 181 underwent catheter removal. Patients treated with ALT received shorter courses of systemic antimicrobials (11 versus 14 days; P &lt; 0.001) and had shorter hospital stays (4 versus 10 days; P &lt; 0.001). Median duration of catheter salvage in patients receiving ALT was 28 days (IQR 7–80). Primary composite outcome was similar between both groups, but ALT was associated with a significantly higher risk of microbiological relapse within 90 days (20% versus 7%; adjusted odds ratio 3.93, 95% CI 1.64–9.40; P = 0.002). No significant difference in 30 day mortality, CVC-related complications or CDI was observed. CoNS BSI was an independent predictor of microbiological relapse in patients treated with ALT (OR 2.28; P = 0.05). Conclusions Although ALT offers a non-invasive catheter salvage strategy, its association with higher relapse rates, particularly in CoNS BSI, suggests catheter removal should remain the preferred approach when feasible. ALT could be considered a short-term catheter salvage strategy for pathogens with low virulence when used with close surveillance.

Abstract Introduction The SleepImage is an HSAT device (sHSAT) that uses photoplethysmography and oxygen saturation data to generate an apnea hypopnea index (AHI). This sHSAT has been FDA cleared as a software-as-a-medical-device for use in children 2 years and older for diagnosing obstructive sleep apnea (OSA). To our knowledge this sHSAT has not been tested on children concurrent with the gold standard polysomnography (PSG). Methods This study evaluated 50 children 2-6 years of age with tonsillar hypertrophy and OSA symptoms with sHSAT during simultaneous in-lab PSG. Aims were to determine the technical feasibility of using sHSAT in this population and to compare sHSAT results to PSG. The primary endpoint was AHI by sHSAT compared to AHI by PSG and presence of OSA. Sensitivity analysis was performed for presence or absence of OSA diagnosis based on sHSAT versus PSG. Bland-Altman and concordance correlation calculations were used for comparisons. Results 50 patients, median age 4 (IQR 3-5), met criteria; 39 completed PSG and HSAT. The sensitivity with sHSAT for OSA prevalence based on proprietary categorization was 94.1%, specificity 22.7%, LR+ 1.22, and LR- 0.26, with PSG OSA prevalence of 43.6%. There was a 9% sHSAT total failure rate, and the device frequently fell off, resulting in TST difference of -226.9 ±182.8 min between sHSAT and PSG. PSG was trimmed to include only segments where HSAT was confirmed to be on before comparisons. Concordance correlation coefficient between sAHI and AHI-PSG was 0.52. The Bland-Altman analysis comparing sAHI and PSG AHI revealed a mean difference of 0.73 (95% confidence limits: -3.47 to 4.93). Considering only obstructive events, the Bland-Altman the sAHI vs the AHI-PSG shows a mean difference of 1.52 (95%CI -5.40 to 8.44). Conclusion This pilot study demonstrated challenges with feasibility in using the sHSAT in this age group given likelihood of technical difficulties leading to absent or truncated data. When compared with PSG, sHSAT demonstrated a high false-positive rate for diagnosis of OSA, particularly concerning if guiding surgical management. This topic is of considerable importance to the practice of pediatric sleep medicine; further investigation of technological advances in this area is imperative. Support (if any)

Background: Patients with severe and life-limiting illnesses transitioning out of the hospital often rely on family caregivers (FCGs) to manage communication with health care teams during hospitalizations and outpatient care. However, FCGs infrequently receive adequate training or support to prepare for these responsibilities. Effective communication between FCGs and health care teams is critical for preparing FCGs and reducing risks for poor outcomes. This study tested an eight-week intervention to improve FCG preparedness and communication practices during transitions out of the hospital. Methods: Conducted from 2018 to 2022, this randomized controlled trial included adult FCGs in rural areas in the United States (Minnesota, Wisconsin, and Iowa). FCGs caring for adults who received inpatient palliative care and were transitioning out of the hospital were eligible. The intervention group received teaching, guidance, and counseling from a palliative care nurse interventionist via video visits before and for eight weeks after discharge. The control group received monthly phone calls but no intervention. Outcomes included changes in FCG-reported preparedness for caregiving and communication with health care teams. Results: Of the 429 consented, 367 (183 intervention and 184 control participants) initiated the intervention; 164 had complete preparedness data, and 161 had complete communication data at baseline and eight weeks. In unadjusted analyses, the intervention group showed statistically significant improvements in preparedness but not communication practices. After adjusting for factors associated with care transitions, the findings persisted. Conclusion: Partnering rural FCGs with palliative care nurses via video can improve caregiver preparedness during care transitions. Improving communication practices may need more targeted strategies.

ImportanceVestibular migraine has no established treatments.ObjectiveTo test the efficacy of rizatriptan for treating vestibular migraine attacks.Design, Setting, and ParticipantsThis double-blind, randomized clinical trial of rizatriptan vs placebo was conducted from December 2014 through July 2020 (data analyses in 2021 and sensitivity analyses in 2022 and 2024) at 2 tertiary neurotologic centers. Adults with vestibular migraine were included.InterventionAll participants underwent prospective observation to confirm diagnosis and illness activity and were then randomized in a 2:1 ratio to receive rizatriptan 10 mg or placebo to treat up to 3 vestibular migraine attacks per participant.Main Outcomes and MeasuresParticipants rated symptoms as absent, mild, moderate, or severe at scheduled intervals. Primary outcomes were the percentage of attacks with reductions in vertigo and unsteadiness/dizziness from moderate or severe to absent or mild at 1 hour. Secondary outcomes were the percentage of attacks with complete resolution of vestibular symptoms at 1 hour; reductions in headache and associated symptoms at 1 hour; use of rescue medications after 1 hour; reductions in vestibular, headache, and associated symptoms at 24 hours without rescue medications; treatment satisfaction and quality of life at 48 hours; and rates of serious adverse effects and discontinuation due to adverse effects.ResultsOf 222 total participants (mean [SD] age, 42.3 [11.7] years; 70.7% were women), 134 (60.4%) with active illness treated 307 attacks. Efficacy was tested using 240 attacks with vestibular symptoms rated as moderate or severe when participants took study drug. At 1 hour, rizatriptan did not differ from placebo for reducing vertigo (73/151 [48.3%] vs 50/88 [56.8%] attacks; odds ratio [OR], 0.71 [95% CI, 0.42-1.21]), unsteadiness/dizziness (29/151 [19.2%] vs 11/89 [12.4%] attacks; OR, 1.69 [95% CI, 0.80-3.57]), or any secondary outcomes. Similar percentages of participants in rizatriptan and placebo groups (26.4% for both groups) added rescue remedies after 1 hour. At 24 hours, rizatriptan had medium effects over placebo for unsteadiness/dizziness (OR, 2.65) and motion sensitivity (OR, 3.58). Post hoc analyses of all treated attacks found a medium effect favoring rizatriptan for headache and photophobia or phonophobia at 24 hours. Treatment satisfaction was equivocal. Quality of life was mixed. No participants experienced serious adverse effects or discontinued treatment for adverse effects.Conclusions and RelevanceIn this study, rizatriptan was ineffective at 1 hour for treating vestibular migraine attacks and had limited benefit on symptoms at 24 hours. Findings do not support using rizatriptan for vestibular migraine attacks.Trial RegistrationClinicalTrials.gov Identifier: NCT02447991

Abstract Rationale: Cardiopulmonary exercise testing is a unique tool for simultaneously assessing cardiopulmonary and metabolic responses at peak exercise, making it invaluable for diagnosing unexplained dyspnea and fatigue, common issues in cardiovascular and pulmonary clinics. However, its use is often limited by complex guidelines, restricted lab access, technical demands, and high costs. The Veterans Specific Activity Questionnaire (VSAQ), developed by Meyers et al., offers a practical way to estimate metabolic equivalents and maximum oxygen consumption to assess exercise capacity. While primarily validated in a male population, the VSAQ lacks sufficient research in diverse ethnic and gender groups. Broader validation could enhance personalized cardiopulmonary testing, support equitable healthcare resource allocation, and help lower costs. Methods: In this prospective observational study, participants were included if they were 18 years or older and capable of completing a cardiopulmonary exercise test. Participants were excluded if they had known abnormal breathing patterns at baseline and if they had any contraindication for cardiopulmonary exercise and pulmonary function testing. A total of 17 patients without known cardiopulmonary disease provided informed consent and completed the brief self-administered VSAQ following the cardiopulmonary exercise test. The VSAQ was used to estimate maximal exercise capacity in metabolic equivalents, which was then compared to the actual maximal exercise capacity achieved on a bike ergometer, as recorded in the electronic medical records. Results: A linear regression analysis indicated a marginal association between VSAQ results (METS) and CPET METS, accounting for 22.2% of the variance in CPET METS (p=0.056). This finding suggests a potential, though not statistically significant, positive relationship between VSAQ METS scores and CPET MET. A linear regression analysis indicated a marginal association between VSAQ calculated Peak VO₂ and observed CPET Peak VO₂ (o₂/kg/min), explaining 21.6% of the variance in CPET Peak VO₂ (p=0.060). This suggests a potential positive relationship between VSAQ calculated Peak VO₂ and CPET Peak VO₂, though the association did not reach statistical significance. Conclusion: In this preliminary sample of patients without known cardiopulmonary disease, the VSAQ demonstrated accuracy in predicting maximum oxygen consumption at peak exercise. With further validation and larger sample size, the VSAQ could become a valuable adjunctive tool for assessing patients with unexplained dyspnea and fatigue, supporting more efficient diagnostic evaluations. Additionally, the VSAQ may serve as a practical follow-up measure to track clinical improvement after therapeutic interventions in this specific population.