Baseline Scores Research Articles

Longitudinal validation of the PROMIS-16 in a sample of adults in the United States with back pain.

This longitudinal study evaluates whether the Patient-Reported Outcomes Measurement and Information System (PROMIS)-16 domains capture average change over time comparable to the PROMIS-29 + 2 and have similar associations with change in overall health rating and two disability indices. Data were collected using Amazon's Mechanical Turk at baseline, 3 months, and 6 months among individuals reporting chronic low back pain. The analytic sample includes respondents who completed baseline and at least one follow-up assessment (N = 1137). We estimated latent growth models for eight PROMIS domains and compared growth parameters between the PROMIS-16 and PROMIS 29 + 2 with a z-test. Additionally, for each domain, random intercept and slope scores for individuals were computed for the PROMIS-29 + 2 and PROMIS-16 and correlated to estimate concordance. Using growth parameters for physical function and pain interference, we predicted average change in the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMDQ), the overall health rating, and compared regression coefficients between the PROMIS-16 and PROMIS 29 + 2. All growth models fit the data well. Intercept and slope parameters were statistically comparable (p's > 0.05) in magnitude across all domains between the PROMIS-16 and PROMIS-29 + 2. Correlations between random intercept and slope scores for individuals across domains were high. Additionally, the regression coefficients between slopes for pain interference and physical function and ODI, RMDQ, and overall health rating were statistically comparable (p's > 0.05) between the PROMIS-16 and PROMIS 29 + 2. Results provide between-level support for the longitudinal and predictive validity of the PROMIS-16. Similar average baseline scores and changes over time were observed between PROMIS-16 and PROMIS-29 + 2. Further, average change estimates comparably predicted average change in distal outcomes. This work provides evidence supporting the utility of the PROMIS-16 as a viable, short-profile option for use in clinical and research settings.

Study protocol for a multicenter randomized controlled trial on simulation-based communication training for pediatric cardiology trainees (SIMUL-CHD).

Effective physician-patient communication is crucial to compassionate healthcare, particularly when conveying life-altering diagnoses such as those associated with congenital heart diseases. Despite its importance, medical practitioners often face challenges in communicating effectively. Because of these gaps, we aim to introduce a simulation-based training protocol to improve pediatric cardiology trainee's communication skills. This study will be conducted in collaboration with associations supporting caregivers of children with congenital heart disease. It strives to demonstrate how specific training programs can efficiently foster humanistic, patient-centered care in standard medical practice. This multicenter, open-label randomized controlled trial will be conducted in pediatric cardiac units and simulation centers of across 10 universities in France. The study population comprises pediatric cardiologists in training (including pediatric cardiac fellows or specialist assistants). The SIMUL-CHD intervention will consist of simulation-based training with standardized patients, focusing on improving communication skills for pediatric cardiology trainees during diagnostic counselling. Patients and caregivers have been recruited from a National Patient Association named "Petit Cœur de Beurre". The primary outcome is the quality of physicians' communication skills. The evaluation committee, which will review video recordings of the sessions, will be blinded to which participants received simulation-based training (group of interest) and which received theory-based training (control group). Secondary outcomes are the effect of SIMUL-CHD on empathy and anxiety levels in young pediatric cardiologists. Baseline scores pre and post-intervention will be compared, and skill improvement resulting from the intervention measured. Simulation-based training has proven efficacy in teaching technical skills in various scenarios however its application to communication skills in pediatric cardiology remains unexplored. The involvement of experienced parents provides a unique perspective, incorporating their profound understanding of the emotional challenges and specific hurdles faced by families dealing with congenital heart disease. This trial is registered with the OSF registry (registered https://osf.io/ed78q ).

Safety and Efficacy of Ashwagandha Root Extract on Cognition, Energy and Mood Problems in Adults: Prospective, Randomized, Placebo-Controlled Study.

This prospective, randomized, placebo-controlled study assessed the effects of Ashwagandha root extract (ARE) on cognition, energy, and mood in adults with self-reported cognitive and energy problems. Healthy subjects aged 30-75 years were randomized to receive ashwagandha (Withania somnifera) root extract (ARE) 600 mg/day (n = 60)/identical placebo (n = 60) orally for 8 weeks. Cognitive function was assessed at baseline and week 8 using a Computerized Mental Performance Assessment System (COMPASS). Secondary outcomes were Profile of Mood States Abbreviated Version (POMS-A), Mental Fatigue Scale (MFS) and Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) for effects on mood, mental fatigue and executive function, respectively, assessed at baseline, week 4 and 8. Greater improvement (p < .05) from baseline scores were seen with ARE as against placebo for COMPASS items episodic memory, working memory and accuracy of attention. ARE also improved the POMS-A, MFS and BRIEF-A scores from baseline suggesting an improvement in mood, vigor, and an increase in the executive functioning respectively with ARE. The herb was well tolerated and had a good patient compliance with no serious adverse events reported in either of the groups. This study suggests that a dose of 600 mg a day can improve cognition, energy, and mood in adults with self-reported cognitive and energy problems.

Application of fine nursing mode in nursing management of blood oncology department

Objective: To explore the effect of fine nursing on cancer-related fatigue (CRF), anxiety, and depression in patients with hematological tumors undergoing chemotherapy, and to provide a feasible intervention plan for clinical management of these symptoms. Methods: A quasi-experimental study was conducted on patients with hematological tumors undergoing chemotherapy, admitted to our hospital from June 2018 to November 2021. A total of 84 eligible patients were randomly divided into two groups: 44 in the experimental group and 40 in the control group. The control group received routine nursing care, including psychological support, diet guidance, catheter care, bleeding prevention, and chemotherapy guidance. The experimental group received an additional 4 weeks of intensive nursing care on top of the routine care. Results: Three patients withdrew from the study, leaving 42 in the experimental group and 40 in the control group. No significant differences were observed between the two groups in terms of demographic and clinical baseline characteristics. Before the intervention, there were no significant differences in CRF, anxiety, and depression scores between the groups. After the intervention, the experimental group showed significantly lower scores in CRF, anxiety, and depression compared to the control group and their own baseline scores. Conclusion: Fine nursing can effectively reduce cancer-related fatigue, anxiety, and depression in patients with hematological tumors undergoing chemotherapy.

Patient-reported disability progression outcomes among patients with multiple sclerosis: Results of an outcomes-based agreement.

Outcomes-based agreements (OBAs) are agreements between payers and manufacturers in which payment for medications is tied to patient outcomes. These contracts aim to measure the value of prescription medications on predefined clinical indicators in real-world patient populations. OBAs are gaining traction in the United States as the health care industry shifts from volume-based to value-based care. Multiple sclerosis (MS) is an appealing therapeutic area for OBAs because of its prevalence, high cost of medications, and multiple effective therapeutic options. To describe findings from an OBA that was prospectively conducted in a large regional health system for patients with MS taking interferon β-1a or dimethyl fumarate. In this prospective real-world analysis, commercial or health insurance exchange members were included based on the parameters of the OBA. Disability progression was assessed using a patient-reported outcome, patient-determined disease steps (PDDS). In the OBA, members aged 18 years or older with an MS diagnosis were included in the contract. A baseline score was collected for eligible members, with follow-up scores occurring between a 90-day and 180-day postbaseline score. If a follow-up score was greater than the baseline score, a subsequent PDDS score was collected between 90-days and 120-days to determine if the PDDS score remained elevated, indicating that the member had disability progression. During the contract period, 410 patients were eligible for PDDS collection, with 241 and 169 patients in the dimethyl fumarate and interferon β-1a cohorts, respectively. There were 162 patients who were lost to follow-up, and 64 patients who were ineligible per contract parameters. Of the remaining 184 eligible patients (107 on dimethyl fumarate and 77 on interferon β-1a), 21 (11%) patients had confirmed disability progression (6 on dimethyl fumarate [5.6%] and 15 on interferon β-1a [19.5%]). Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA.

Dissociation of White Matter Bundles in Different Recovery Measures in Poststroke Aphasia.

Poststroke aphasia (PSA) recovery shows high variability across individuals and at different time points. Although diffusion biomarkers from the ventral and dorsal streams have demonstrated strong predictive power for language outcomes, it is still unclear how these biomarkers relate to the various stages of PSA recovery. In this study, we aim to compare diffusion metrics and language measures as predictors of language recovery in a longitudinal cohort of participants with PSA. Participants were recruited at a stroke unit at the emergency room, and underwent diffusion magnetic resonance imaging scanning and language assessment within 3 days (acute phase) after stroke, with behavioral follow-ups at subacute (10±3 days) and chronic phases (>6 months). We conducted regression analyses on language performance (cross-sectional), Δscores between all time points (acute-subacute, subacute-chronic, acute-chronic), and relative Δscores between all time points (Δscore/language baseline score), with acute diffusion metrics from language-related white matter tracts, lesion size, language baseline scores, and demographic data as predictors. Thirty-nine participants presenting PSA were recruited, and 24 participants (mean age, 73 years; 8 women) completed the 3-time point assessment in total. The best prediction model of performance scores used axial diffusivity from the left arcuate fasciculus in both the subacute (R2=0.785) and chronic stages (R2=0.626). Moreover, the prediction of ∆scores depended on axial diffusivity from the left inferior frontal-occipital fasciculus in the subacute stage (R2=0.5) and depended additionally on axial diffusivity from the right inferior frontal-occipital fasciculus in the chronic stage (R2=0.68). The prediction of mediation analyses showed that the lesion load of the left arcuate fasciculus mediated the relationship between axial diffusivity from the left arcuate fasciculus and chronic language performance. Language performance at subacute and chronic time points could be predicted by the integrity of the left arcuate fasciculus, whereas Δscores in the subacute and chronic phases depended on the left inferior frontal-occipital fasciculus, showing a dissociation of the white matter pathways about language outcomes. These results suggest a functional differentiation of the dual-stream components in PSA recovery.

The Intra-Meatal Application of Tadalafil Cream Versus Oral Administration Efficacy and Safety: Results from a Randomized, Two-Administration Route, Cross-Over Clinical Trial

Background: Tadalafil cream, a topically administered phosphodiesterase-5 inhibitor (PDE5), presents a potential alternative to oral PDE5 inhibitors like tadalafil for the treatment of erectile dysfunction (ED). This study evaluates the non-inferiority and potential superiority of tadalafil cream compared to oral tadalafil. Methods: This randomized controlled trial employed a cross-over design with two treatment periods of two weeks each, separated by a one-week washout phase. Thirty-five male participants aged 18–75 with diagnosed ED (International Index of Erectile Function–Erectile function: IIEF-EF score &lt; 26) were randomized to receive either tadalafil cream or oral tadalafil. Tadalafil cream was applied topically, while tadalafil was taken orally. The primary endpoint was IIEF-EF, and secondary endpoints were measured using the International Index of Erectile Function (IIEF) domain scores. Adverse events and treatment preferences were also assessed. Results: Tadalafil cream showed a higher increase in sexual function across all IIEF domains compared to oral tadalafil. The lower bounds of the confidence interval [improvement: final−baseline scores between tadalafil cream and oral tadalafil 0.72 (95% CI −2.72–4.15)] were above the non-inferiority margin of −3.22, confirming tadalafil cream’s non-inferiority in the erectile function domain. In the intercourse satisfaction domain, tadalafil cream was superior to oral tadalafil. At the end of the trial, 88.57% of participants preferred tadalafil cream (95% CI 73.26%–96.79%), a result significantly above the non-inferiority margin that indicated superiority (p &lt; 0.001). No systemic adverse events were reported for tadalafil cream, and significant differences in dizziness, headache, nasal congestion, and erythema were observed between the two treatments. Conclusions: Tadalafil cream is a safe and effective treatment for erectile dysfunction, demonstrating non-inferiority and potential superiority over oral tadalafil, with a high patient preference. Its topical administration offers a promising alternative for patients, particularly those with cardiovascular diseases where oral PDE5 inhibitors are contraindicated or less well tolerated.

Predictors of dropping out from a home tele-exercise programme: A cohort study derived from a randomised controlled trial

Background: Online home exercises represent opportunities to increase physical activity levels. However, high dropout rates are commonly reported in such programmes. This study aimed to investigate the predictors of dropping out from an online home exercise programme. Methods: A total of 760 individuals from nine countries participated in this 8-week prospective cohort study derived from a randomised controlled trial. The participants were randomised into "4-week live-streamed exercise –&gt;4-week recorded exercise" or "4-week no intervention –&gt;4-week recorded exercise" group. Repeated measurements using weekly questionnaires were performed. Pain intensity, disability, mental well-being score, exercise motivation, sleep quality, impulsiveness/anxiety, and physical activity level were analysed. Results: A total of 53.8% (95% confidence interval [CI] 50.3%–57.3%) participants dropped out from the programme. The identified predictors of dropping out from the programme were: well-being (odds ratio [OR] 0.94, 95% CI 0.91–0.97) and disability (OR 1.02, 95% CI 1.002–1.04) at baseline considering the first 4 weeks; age (0.98; 95% CI 0.96–1.00) and baseline well-being (0.93; 95% CI 0.89–0.97) considering the entire follow-up (8 weeks); exercise motivation (0.92; 95% CI 0.87 to 0.97) and general impulsiveness/anxiety (1.04; 95% CI 1.01–1.07) repeated measured over time. Conclusion: About half of the participants dropped out from the online home exercise programme. Higher baseline scores in mental well-being and age predicted a reduction in dropping out. Higher baseline disability predicted an increase in dropping out. During the follow-up, higher exercise motivation was associated with a reduction in dropping out, and higher impulsiveness and anxiety were associated with an increase in dropping out.

Basic self-disturbance in adolescents at risk of psychosis: temporal stability investigated by the experience sampling method in a mixed method study.

Basic self-disturbance (BSD), also called anomalous self-experiences (ASEs), are core phenotypic markers for schizophrenia spectrum disorders and a prepsychotic vulnerability marker considered to be temporally stable (trait-phenomenon). Studies of BSD in children and adolescents are lacking. To be clinically useful, we need to know more about the characteristics and temporal development of BSD in prepsychotic phases. This study used a smartphone application measuring the occurrence and subjective intensity of ASEs in the daily life of 27 help-seeking adolescents (12-18 years) repeatedly over a period of 6 months. A total of 5223 unique application-reports based on individually selected and verbatim descriptions of personal core ASEs were analysed by mixed methods. The intensity of ASEs, within subjects and between subjects and irrespective of time intervals or baseline scores obtained by the Examination of Anomalous Self-Experience (EASE) were relatively stable with a mean variability of 1.25 (0.4) SD. Participants with low EASE total scores at baseline had a significantly lower score on ASE intensity than those with high baseline EASE total scores at baseline (mean 2.42 vs 3.42, p=0.046). In this study, ASEs were not reported as essentially fluctuating experiences but as almost constantly present, demonstrating BSD as a mainly trait phenomenon in prepsychotic phases in persons under the age of 18. Considering the continuous experience of BSD and its predictive value for psychosis development, ASEs should be targeted and monitored to the same extent as other prepsychotic features.

Psychometric Properties and Meaningful Change Thresholds of the Vitiligo Area Scoring Index

Defining meaningful improvement using the Total Vitiligo Area Scoring Index (T-VASI) and the Facial VASI (F-VASI) aids interpretation of findings from clinical trials evaluating vitiligo treatments; however, clear and clinically meaningful thresholds have not yet been established. To assess concept validity and measurement performance of the T-VASI and F-VASI in patients with nonsegmental vitiligo and to identify meaningful change thresholds. This mixed-methods study consisted of a secondary analysis of a phase 2 multicenter double-blind dose-ranging randomized clinical trial and embedded qualitative interviews conducted at 35 sites in Canada, France, Japan, and the US. The secondary analysis included the trial's adult patients with nonsegmental vitiligo (T-VASI ≥5 and F-VASI ≥0.5 at baseline). Psychometric performance of the T-VASI and F-VASI and thresholds for meaningful change were evaluated using clinician- and patient-reported information. The trial's embedded interviews were used to qualitatively assess content validity and patient perceptions of meaningful repigmentation. Data analyses were performed from March to July 2023. Participants were randomized to 6-, 11-, or 22-mg/day upadacitinib or placebo for 24 weeks. Psychometric performance of the T-VASI and F-VASI and thresholds for meaningful changed plus content validity and patient perceptions of meaningful repigmentation. Measurement instruments included the T-VASI, F-VASI, Vitiligo Noticeability Scale, Total-Patient Global Vitiligo Assessment, Face-Patient Global Vitiligo Assessment, Total-Physician Global Vitiligo Assessment (PhGVA-T), Face-Physician Global Vitiligo Assessment (PhGVA-F), Patient's Global Impression of Change-Vitiligo, Physician's Global Impression of Change-Vitiligo (PhGIC-V), Vitiligo Quality-of-Life Instrument, Dermatology Life Quality Index, the Hospital Anxiety and Depression Scale, and transcribed verbatim interviews with patients. The psychometric analysis included 164 participants (mean [SD] age, 46 years; 103 [63%] females) and the qualitative analysis included 14 participants (mean [SD] age, 48.8 [12.2] years; 9 females [64%] and 5 males [36%]). Intraclass correlation coefficients were 0.98 for T-VASI and 0.99 for F-VASI in patients with clinically stable vitiligo between baseline and week 4, supporting test-retest reliability. At baseline and week 24, correlations were moderate to strong between T-VASI and PhGVA-T (r = 0.63-0.65) and between F-VASI and PhGVA-F (r = 0.65-0.71). Average baseline and week-24 VASI scores decreased with repigmentation (ie, increasing PhGVA scores). Least-square mean VASI scores increased with greater repigmentation as measured by the PhGIC-V. Least-square mean VASI scores also differed between patients with improved PhGIC-V and those with no change or worsened V-PhGIC scores. Using a multiple anchor approach, improvements of 30% in T-VASI and 50% in F-VASI scores reflected meaningful repigmentation between baseline and week 24. This mixed-methods study found that the T-VASI and F-VASI are reliable, valid, able to differentiate between clinically distinct groups, and responsive in patients with nonsegmental vitiligo. The thresholds for meaningful change were lower than those historically used in clinical trials, suggesting that T-VASI 50 and F-VASI 75 are conservative estimates and reflect improvements that would be meaningful in patients with nonsegmental vitiligo. ClinicalTrials.gov Identifier: NCT04927975.

Efficacy of Topical Rosemary Extract Lotion Versus Topical 2% Ketoconazole Lotion in the Treatment of Seborrheic Dermatitis: A Double Blind Randomized Controlled Clinical Trial

Introduction: Seborrheic dermatitis manifests as greasy, itchy lesions, commonly affecting sebum-rich areas like the scalp and face. Its prevalence is 11.6% in the general population, with various internal and environmental factors contributing to its development. Objectives: This study aimed to compare the efficacy of rosemary extract lotion in the treatment of seborrheic dermatitis in comparison with topical 2% ketoconazole lotion. Methods: This double-blind, randomized clinical trial included 42 patients with scalp seborrheic dermatitis, divided into rosemary and ketoconazole lotion groups. Both lotions were applied twice daily for 2 months. The severity of scalp dandruff was assessed using the Adherent Scalp Flaking Score. Itchiness of the scalp and quality of life were assessed using itchy quant and the Dermatology Life Quality Index (DLQI), respectively. Stata software was applied for statistical analysis. Results: The reduction in the Adherent Scalp Flaking Score score was statistically significant the ketoconazole group compared to the patients in the rosemary group (P value = 0.011). However, the reduction in itching score was statistically significant more in the rosemary group at the end of the first and second months in comparison to the ketoconazole group (P value &lt; 0.001). The statistical analysis demonstrated no significant difference in the reduction of DLQI scores between the rosemary and ketoconazole groups at the end of 1 and 2 months after starting the treatment in both crud and adjustment with base-line score analysis. Conclusion: Both rosemary and ketoconazole lotions were effective in treating scalp seborrheic dermatitis and decreasing the patient's DLQI score.

Exploring the Potential of Electronic Patient-Generated Health Data for Evaluating Treatment Response to Intramuscular Steroids in Rheumatoid Arthritis: Case Series.

Mobile health devices are increasingly available, presenting exciting opportunities to remotely collect high-frequency, electronic patient-generated health data (ePGHD). This novel data type may provide detailed insights into disease activity outside usual clinical settings. Assessing treatment responses, which can be hampered by the infrequency of appointments and recall bias, is a promising, novel application of ePGHD. Drugs with short treatment effects, such as intramuscular steroid injections, illustrate the challenge, as patients are unlikely to accurately recall treatment responses at follow-ups, which often occur several months later. Retrospective assessment means that responses may be over- or underestimated. High-frequency ePGHD, such as daily, app-collected, patient-reported symptoms between clinic appointments, may bridge this gap. However, the potential of ePGHD remains untapped due to the absence of established definitions for treatment response using ePGHD or established methodological approaches for analyzing this type of data. This study aims to explore the feasibility of evaluating treatment responses to intramuscular steroid therapy in a case series of patients with rheumatoid arthritis tracking daily symptoms using a smartphone app. We report a case series of patients who collected ePGHD through the REmote Monitoring Of Rheumatoid Arthritis (REMORA) smartphone app for daily remote symptom tracking. Symptoms were tracked on a 0-10 scale. We described the patients' longitudinal pain scores before and after intramuscular steroid injections. The baseline pain score was calculated as the mean pain score in the 10 days prior to the injection. This was compared to the pain scores in the days following the injection. "Response" was defined as any improvement from the baseline score on the first day following the injection. The response end time was defined as the first date when the pain score exceeded the pre-steroid baseline. We included 6 patients who, between them, received 9 steroid injections. Average pre-injection pain scores ranged from 3.3 to 9.3. Using our definitions, 7 injections demonstrated a response. Among the responders, the duration of response ranged from 1 to 54 days (median 9, IQR 7-41), average pain score improvement ranged from 0.1 to 5.3 (median 3.3, IQR 2.2-4.0), and maximum pain score improvement ranged from 0.1 to 7.0 (median 4.3, IQR 1.7 to 6.0). This case series demonstrates the feasibility of using ePGHD to evaluate treatment response and is an important exploratory step toward developing more robust methodological approaches for analysis of this novel data type. Issues highlighted by our analysis include the importance of accounting for one-off data points, varying response start times, and confounders such as other medications. Future analysis of ePGHD across a larger population is required to address issues highlighted by our analysis and to develop meaningful consensus definitions for treatment response in time-series data.

Cardiac amyloidosis and left atrial appendage closure: a multicenter retrospective study

Abstract Background Thromboembolic stroke risk remains a clinical challenge in cardiac amyloidosis (CA) patients with atrial fibrillation because of the increased prevalence of left atrial appendage thrombi irrespective of CHA2DS2-VASc score and a higher prevalence of factors that increase the risk of bleeding with anticoagulation. Left atrial appendage closure (LAAC) is an effective option in patients with atrial fibrillation and high bleeding risk; however, data describing a LAAC strategy for stroke prevention in patients with CA is limited. Among non-CA patients, procedural success and serious complication rates are around 98% and 3% respectively. Purpose In this multicenter retrospective study, we aimed to investigate whether left atrial appendage closure (LAAC) could reduce the risk of bleeding complications and ischemic cerebrovascular events in patients with CA. Methods In an international multi-center retrospective study, patients with CA that underwent LAAC were included. The diagnosis of CA was established on the basis of histologic confirmation or advanced multimodality cardiac imaging as per current consensus statements. Results A total of 28 patients (93% male; 87% ATTR-CA; 13% AL-CA; mean age 80 years) met inclusion criteria. At baseline, mean CHA2DS2-VASc and HAS-BLED scores were 4 and 3 respectively, mean left ventricular ejection fraction was 50%, and mean indexed left atrial volume was 58 mL/m2. 21% of patients had a prior history of ischemic stroke, 14% prior history of hemorrhagic stroke, 7% prior transient ischemic attack, and 54% had a prior history of major or minor bleeding. Procedural success was achieved in 26 patients (93%) with procedural complications occurring in 2 patients (vascular access site bleeding and cardiac tamponade). Regarding in-hospital and follow-up complications, 0% ischemic stroke, 0% hemorrhagic stroke, and major or minor bleeding in 4% of patients. During follow up, device thrombosis occurred in only 1 patient. Conclusion LAAC is a feasible and effective alternative to anticoagulation in patients with CA and excessive bleeding risk, with procedural success and complication rates similar to reported studies of non-CA patients.

Ketamine and chronic treatment-resistant depression: real-world practice and after relapse

BackgroundChronic treatment-resistant depression (TRD) poses a major challenge for clinicians. Ketamine has shown a rapid but short-lived antidepressant effect in several studies involving TRD patients with different demographic and clinical profiles. Our study aimed to assess the antidepressant effect of serial infusion sessions of ketamine in patients with chronic TRD and evaluate the severity of symptoms after relapse and the general psychiatric health of the responding patients.MethodsIn this single arm open-label study, six infusions of ketamine at 0.5 mg/kg were administered to chronic TRD patients for approximately two weeks. Response and remission rates, side effects, adverse events and after-relapse symptoms were evaluated, and patients were followed for three months.Results23 patients underwent at least one infusion session, and 18 patients completed the six sessions. Twelve (66.67%) patients responded to the treatment at some point, and 11 (61.11%) patients maintained response after the end of the treatment protocol. One infusion was not sufficient to achieve a response (P > 0.9999, z = 1.81), and more than half of the responders met the response criteria after the third infusion. Only one patient (5.56%) achieved remission at the end of the infusion phase. All but one ketamine responders relapsed within one month after the end of the treatment. There was no statistical difference between baseline and after-relapse MADRS scores (P = 0.7886, 95% CI=-5.512-4.312, R2 = 0,008411). However, a high incidence of serious adverse events related to suicidality was evident; one of the non-responding patients attempted suicide and several attempts to sedate this patient with benzodiazepines failed. Two responding patients ended up with a suicidal attempt or severe suicidal thoughts.ConclusionsIntroducing rapid-acting antidepressant to manage TRD patients in clinical practice demands further investigation, and the benefit-to-harm ratio should be assessed in the light of the increased risk of suicidality.

Multidomain cognitive improvement in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation

Abstract Background Cognitive impairment is prevalent in one third of patients with symptomatic severe aortic valve stenosis scheduled for transcatheter aortic valve implantation (TAVI). How TAVI affects cognitive functioning in these patients remains unknown. Purpose The CAPITA study (CArdiac outPut, cerebral blood flow and cognition In patients with severe aortic valve stenosis undergoing Transcatheter Aortic valve implantation) assessed the effects of TAVI on cerebral lesions and cognitive functioning. Methods CAPITA is a prospective study of cerebral and cognitive outcomes in 148 patients undergoing TAVI. One day before and three months after TAVI, patients underwent a standardized multidomain neuropsychological assessment, and simultaneous brain magnetic resonance imaging. The primary outcome was change in global cognitive functioning as measured with z-scores. Also, we assessed the cognitive subdomains of attention/psychomotor speed, memory, language, and executive functioning. Z-scores for each cognitive domain were constructed as: (test score - mean baseline score) / standard deviation. Global cognitive function was calculated as the mean from the four domain scores. Results Mean age was 80.5±5.7 years, 43% was female and median STS-PROM (Society for Thoracic Surgeons Predicted Risk for 30-day Mortality) was 2.0% (IQR 1.4%-2.9%). MoCA scores improved from 23.3±3.7 to 24.4±3.3, (p&amp;lt;0.001) and MMSE scores from 26.4±2.6 to 26.9±2.4 (p=0.01). There was an overall increase in global cognitive z-scores (0.02±0.52 to 0.15±0.48, p&amp;lt;0.001). Cognitive domains of memory (0.03±0.77 to 0.18±0.80, p=0.003) and language (-0.07±1.07 to 0.20±0.80, p=0.02) significantly improved, whereas executive function (0.01±0.70 to 0.06±0.76, p=0.42) and attention (0.10±0.69 to 0.17±0.69, p=0.06) did not significantly change. Quality of life on the visual analogue scale improved from 66.4±15.9 to 72.9±12.8, (p&amp;lt;0.001). Patients in the lowest tertile of baseline cognitive functioning (i.e., those with worst baseline cognitive functioning), had the largest increase in cognitive functioning, compared with patients in the intermediate or highest tertile of baseline cognitive functioning (0.30±0.55 vs 0.09±0.27 vs 0.01±0.16, p=0.002). Patients with &amp;gt;0.5 SD decline in cognitive functioning (12%), had a higher volume of new white matter hyperintensities on follow-up MRI than patients with stable or improved cognitive functioning (1.26±2.96, vs 0.29±0.45 vs 0.31±0.91 mL, p=0.06). Conclusions In 148 patients who underwent TAVI, there was an overall improvement in cognitive functioning at three months follow-up. This improvement was consistent through different cognitive domains and most prominent in patient with lowest baseline cognitive functioning.Change in cognitive functionin

Effectiveness and Long-Term Effects of SER+ FELIZ(mente): A School-Based Mindfulness Program for Portuguese Elementary Students

School-based mindfulness programs (SBMPs) have gained global popularity. Yet, there is a need for more rigorous procedures to develop and assess them. This study aimed to address these limitations by examining the effectiveness of a Portuguese SBMP, called SER + FELIZ(mente). The final sample included 190 third and fourth-graders: 99 in the SBMP group and 91 in a wait-list group. Effects on attentional control, emotional regulation and wellbeing were examined in the short term (T2) and 6 months later (T3). We also tested the moderating role of age, gender, and baseline scores. Using a multilevel modeling approach, results showed a clear benefit of SBMP on emotional wellbeing at T2 but not T3. Despite SBMP students surpassing wait-list students in attentional control, cognitive reappraisal, and social wellbeing at T2, these effects were due to a levelling off among SBMP students, coupled with a decline among wait-list students from T1 to T2. These effects were moderated by age at T3. While universal improvements were limited, our SBMP seemed to have acted as a shield against school stressors (i.e., likely, test anxiety at T2). This opens a new avenue for research concerning the role of SBMPs in preventing (rather than repairing) mental-health issues in elementary students.

Effect of iberdomide on cutaneous manifestations in systemic lupus erythematosus: a randomized phase 2 clinical trial

Iberdomide, a cereblon modulator, promotes degradation of transcription factors Ikaros and Aiolos. Evaluate iberdomide efficacy and safety in cutaneous lupus erythematosus (CLE) in a phase 2 study. Patients were randomized (2:2:1:2) to iberdomide 0.45 (n=81), 0.30 (n=82), or 0.15 mg (n=42) or placebo (n=83) daily while continuing background lupus medications. The mean (SD) baseline Cutaneous Lupus Area and Severity Index Activity (CLASI-A) score was 6.9 (7.0); 28% of patients had a score ≥8; 56% had acute CLE, 29% chronic CLE, and 16% subacute CLE. Mean CLASI-A improvement in patients with baseline score ≥8 was 39.7% for iberdomide 0.45 mg versus 20.1% for placebo at week 4 (P=0.032), with continued improvement through week 24 (66.7% vs 54.2%; P=0.295). Proportions of patients achieving ≥50% CLASI-A reduction from baseline at week 24 were significantly greater for iberdomide 0.45 mg versus placebo for patients with subacute (91.7% vs 52.9%, P=0.035) and chronic (62.1% vs 27.8%; P=0.029) CLE but not for the overall population (55.6% vs 44.6%) or patients with baseline CLASI-A ≥8 (66.7% vs 50.0%). Small patient subgroups of CLE subtypes. Iberdomide showed beneficial effects when added to background lupus medications in patients with subacute and chronic CLE.

Preschoolers’ knowledge acquisition from German educational media: The impact of a training program fostering media sign literacy

ABSTRACT Evidence shows that the first component of media literacy to develop in children is media sign literacy (MSL), an ability that focuses on the understanding and correct use of the signs and symbol systems that organize different media. Previous research has shown that MSL is a significant predictor of learning from media. In this study, we investigated the impact of a self-developed tablet-based MSL training on children’s knowledge acquisition from educational media. A sample of 144 preschoolers aged 4 to 5 years old either received the training (training group) or did not (control group). The training program was executed over a period of 4 weeks. After the program, all participants answered recognition and inference questions about an educational film and an audiobook to assess their knowledge acquisition. The children’s verbal and nonverbal intelligence (both before the training) and MSL (before and after the training) were also assessed. The results showed that the training successfully improved the children’s MSL. Further, the children in the training group had significantly higher recognition and inference scores for the film, along with significantly higher inference scores for the audiobook. Regression analyses also revealed that MSL baseline scores (pretraining) predicted knowledge acquisition from the film but not audiobook.

Contribution of cognitive status on admission to mobility and balance at discharge from acute rehabilitation for stroke

Acute inpatient rehabilitation is crucial for improving mobility and balance for individuals with stroke. A potentially important factor in the recovery of mobility and balance is cognition. The purpose of this study was to determine the effect of cognition on mobility and balance in acute stroke rehabilitation. This was a longitudinal cohort study based on an inpatient rehabilitation unit at a large academic medical center. Participants were individuals with stroke admitted to acute rehabilitation after an acute care hospital stay (N = 281). Demographic data and predictor variables were collected on admission to the unit. Outcomes were collected at discharge from the unit. Multiple regression analyses were used to determine the associations between cognition (Montreal Cognitive Assessment) on mobility (Functional Independence Measure mobility subscale) and balance (Berg Balance Scale). Subtests from the Montreal Cognitive Assessment were also examined to determine if specific dimensions of cognition could predict balance after controlling for covariates. Dominance analysis was used to determine the relative importance of baseline predictors. In separate models, cognition was a significant predictor of mobility (B = 0.19) and balance (B = 0.28) at discharge after adjusting for admission mobility and balance, as well as age, sex, and length of stay. The most important predictors in both models were baseline mobility and balance, but cognition contributed to the models independently of baseline scores. Cognition was generally more important than age and sex while about equally important as length of stay. In separate models, the visuospatial/executive (B = 0.42) and the delayed recall (B = 0.37) subtests were also significant predictors of mobility. The models’ most important predictors were baseline mobility and balance scores. Cognition is a clinically relevant predictor of mobility and balance in acute stroke rehabilitation. Specific dimensions of cognition, such as executive function, visuospatial function, and delayed recall, may be especially important. Cognitive challenges and meta-cognitive strategies should be included in mobility and balance tasks when possible. Studies that evaluate the efficacy of dual-task training and meta-cognitive approaches are needed.

Translational Quotient as an Innovative Outcome Parameter to Assess the Effectiveness of Training Methods: A Feasibility Study in Assessing the Baseline Psychiatric Skills of Primary Care Doctors in their Real-world Live Outpatient Clinic

Background: The effectiveness of training methods in medical education is critical, particularly for primary care physicians (PCPs) who frequently encounter psychiatric issues in their practice. Traditional assessment methods often fail to evaluate skill acquisition in real-world clinical practice. The Translational Quotient (TQ) is proposed as an innovative outcome measure to assess PCPs’ ability to apply psychiatric skills in their live outpatient consultation among their general patients. This study aims to evaluate the feasibility of using the TQ in real-world outpatient clinics and to understand the baseline psychiatric skills among PCPs using TQ. Methods: Actively practicing MBBS-qualified PCPs enrolled in the Diploma in Primary Care Psychiatry (DPCP) program across various districts were invited to participate. Baseline TQ assessments were conducted in the PCPs’ live clinics, with psychiatrists observing live consultations either remotely or in-person for the first five consecutive general consultations. Each consultation was scored using a standardized TQ proforma, which evaluated six criteria: elicitation of psychiatric symptoms, clinical reasoning, medication choices, counseling, time management, and overall clinical skills. Results: A total of 25 PCPs participated, with an average baseline TQ score of 15.7% (4.72 out of 30). Most participants (72%) scored 5 or less, highlighting significant gaps in psychiatric skills. Analysis revealed no significant associations between TQ scores and PCP demographics such as age, gender, and prior psychiatric training, but regional differences were noted, with lower scores in Karnataka compared to Bihar. Conclusions: The TQ is a feasible and practical tool for assessing real-world psychiatric skills among PCPs. The baseline scores indicate a pressing need for targeted psychiatric training to bridge the treatment gap in primary care. Future training programs should focus on enhancing diagnostic accuracy, treatment planning, and patient communication to improve mental healthcare outcomes in primary care settings.