Experimental insights into cognition, motor skills, and artistic expertise in Paleolithic art.

The production of Paleolithic art represents one of the most intricate technical and cognitive endeavors of Homo sapiens, marked by its profound antiquity and vast temporal and spatial framework. Despite its significance, there have been no prior studies aimed at understanding the cognitive and motor skills linked to the creation of realistic images characteristic of this artistic cycle. This research integrates archaeology and experimental psychology, premised on the assumption that the neurological basis of Anatomically Modern Humans has not changed substantially since the Upper Paleolithic. This work employs an innovative interdisciplinary approach, utilizing psychometric tests and drawing and engraving tasks monitored by motion-sensing gloves, to compare the performance of experts and non-experts in visual arts when faced with challenges akin to those of Upper Paleolithic artistic production. The results revealed that expertise in visual arts is linked to enhanced spatial abilities and specific patterns in drawing from memory. Additionally, both experts and non-experts displayed similar motor skills when engraving using Paleolithic techniques, suggesting that these techniques required specialized training in the contemporary experts. In conclusion, this research deepens our understanding of the processes involved in Upper Paleolithic artistic production.

Randomized Controlled Trial of Interventions Used by Midwives to Treat Fear of Childbirth.

BACKGROUND: Fear of childbirth affects women worldwide and can have adverse consequences. Midwives have implemented a number of interventions, autonomously or as part of a professional team. However, midwives have been unable to identify the most appropriate intervention for ensuring the reduction or alleviation of this fear to provide the best perinatal outcomes. OBJECTIVE: This study aimed to evaluate the effectiveness of a prenatal educational intervention followed by specific support during childbirth, designed and delivered exclusively by midwives for women with a high fear of childbirth. METHOD: This randomized controlled trial was performed with two arms in two phases: an online prenatal education phase followed by a support phase during childbirth. Participating women with a high fear of childbirth, which was determined using the Wijma Delivery Expectancy Questionnaire-A-Spanish version, were assigned to the experimental group or the usual care control group at a 1:1 ratio. RESULTS: Women showed a reduction in fear of childbirth in both phases of the study. According to the intention to treat analysis, a significant mean difference was observed in the prenatal stage in favor of the intervention group, as well as a nonsignificant difference in favor of this same group after delivery. DISCUSSION: The effectiveness of continuous specific prenatal education with preferential support during childbirth by midwives was indicated by improvements in the level of fear of childbirth.

The profile of refractory chronic cluster headache.

INTRODUCTION: Chronic cluster headache (CCH) is a relatively rare primary headache disorder whose management is often challenging. The prevalence of refractory CCH (rCCH) is unknown. Our aim is to describe the frequency of rCCH within a population of CCH, define the clinical profile of the refractory patients and the treatments they underwent. METHODS: We conducted a cross-sectional study through a review of the medical records of CCH patients in six hospitals in Madrid, Spain. Data on epidemiological, clinical presentation, treatment and disease activity at the moment were collected. The European Headache Federation diagnostic criteria were used for rCCH definition. High disease activity was defined as having at least 3 severe attacks per week that impact quality of life despite treatment. Non-rCCH and rCCH groups were compared. RESULTS: 88 CCH patients were analyzed, 68.2% (60/88) met rCCH criteria at some point in their evolution. A longer diagnostic delay (4.6 ± 7.1 vs. 3.2 ± 3.7 years, p = 0.017) was observed in rCCH. All rCCH patients tried therapies without established evidence from randomized clinical trials. OnabotulinumtoxinA and galcanezumab were initiated in 77.3% (68/88) and 5.7% (5/88), but discontinued in 52.9% (36/68) and 60.0% (3/5), respectively. Occipital nerve stimulation (ONS) was implanted in 29.6% (26/88), with 50.0% (13/26) still active. Other treatment options are described and discussed. Despite treatment, 60.2% (53/88) still have high disease activity. CONCLUSION: CCH is a disorder with poor prognosis, meeting refractoriness criteria in more than half. OnabotulinumtoxinA and ONS could be the effective in refractory patients.

Nutritional Quality of the Mid-Afternoon Snack of Schooled Children between the Ages of 3 and 12 Years in Three Areas in Spain.

BACKGROUND: The aim of this study was to analyze the nutritional quality of mid-afternoon snacks for schooled children aged 3 to 12 years in three areas of Catalonia (Spain). METHODS: A descriptive observational study collected information on habits and the mid-afternoon snack of 782 schooled children aged 3 to 12 years in three cities, Barcelona, Girona, and Lleida, located in Catalonia (Spain). The children's families voluntarily agreed to complete an online questionnaire that collected information about demographic data and snacking habits in the afternoon, as well as a record of mid-afternoon snack intake over three school days. RESULTS: A total of 2163 mid-afternoon snacks were analyzed from a sample of 764 families with 3 to 12 year-old children. Sandwiches emerged as the most prevalent choice, accounting for 41.89%, followed by pastries at 23.86%, fruit at 14.38%, and a combination of fruit and pastries at 6.29%. Of the mid-afternoon snacks recorded, 22.19% were healthy, 20.90% were quite healthy, 12.85% were quite unhealthy, and 44.06% were unhealthy. CONCLUSIONS: The nutritional quality of mid-afternoon snacks for a large majority of schooled children should be improved. It is essential to develop food education programs to improve the quality of this intake from early childhood and to consider it as an opportunity to adjust the daily dietary requirements of Spanish children.

Vulnerability Factors, Adjustment, and Opioid Misuse in Chronic Noncancer Pain Individuals.

Several person variables predate injury or pain onset that increase the probability of maladjustment to pain and opioid misuse. The aim of this study was to evaluate the role of 2 diathesis variables (impulsiveness and anxiety sensitivity [AS]) in the adjustment of individuals with chronic noncancer pain and opioid misuse. The sample comprised 187 individuals with chronic noncancer pain. The hypothetical model was tested using correlation and structural equation modeling analyses. The results show a significant association between impulsiveness and AS and all the maladjustment variables, and between impulsiveness and AS and opioid misuse and craving. However, although the correlation analysis showed a significant association between adjustment to pain and opioid misuse, the structural equation modeling analysis showed a nonsignificant association between them (as latent variables). The findings support the hypothesis that both impulsiveness and AS are vulnerability factors for maladaptive adjustment to chronic pain and opioid misuse. PERSPECTIVE: This article adds to the empirical literature by including AS and impulsiveness as antecedent variables in a model of dual vulnerability to chronic pain maladjustment and opioid misuse. The findings suggest the potential utility of assessing both factors in individuals in the first stages of chronic pain.

Measuring Pain-related Behavioral Inhibition and Behavioral Activation System Responses: Further Validity Evidence for the Pain Responses Scale.

OBJECTIVES: The Pain Responses Scale and its Short Form (PRS-SF) were recently developed to assess the affective, behavioral, and cognitive responses to pain based on the behavioral inhibition system (BIS) and behavioral activation system (BAS) model of chronic pain. The purpose of this study was to provide additional tests of the psychometric properties of the PRS-SF in a new sample of individuals with chronic pain. METHODS: A sample of Spanish adults (N = 190) with chronic non-cancer pain completed a translated version of the PRS-SF and a battery of questionnaires measuring validity criteria hypothesized the be associated with BIS and BAS activation, including measures of sensitivity to punishment, sensitivity to reward, pain intensity, pain interference, catastrophizing, and pain acceptance. RESULTS: Confirmatory factor analysis supported a 4-factor structure for the PRS-SF assessing despondent, escape, approach, and relaxation responses (S-B χ 2 [5] = 1.49, Comparative Fit Index = 0.99, Non-Normed Fit Index = 0.99, root-mean-square error of approximation = 0.051, Akaike Information Criterion = 4113.66), with marginal internal consistency for 1 scale (relaxation) and adequate to good internal consistency for the others. The pattern of associations found between the PRS-SF Scale scores and the validity criterion supports the validity of the instrument. CONCLUSION: The results provide additional support for the validity of the 4 PRS-SF Scale scores, and the reliability of 3 of the scales. If these findings are replicated in future research, investigators may wish to administer more items from the original Relaxation Scale when assessing this domain to ensure adequate reliability for this scale. The other items from the PRS-SF assessing despondent, escape, and approach responses appear to provide at least adequate reliability. When used in this way, the PRS-SF may be used to measure BIS and BAS responses to pain to: (1) provide further tests of the BIS-BAS model of chronic pain and/or (2) understand the potential mediating effects of BIS and BAS responses on the effects of psychological pain treatments to help determine which specific responses are most responsible for the benefits of treatment, and, therefore, which responses should be specifically targeted to enhance treatment response.

Clinical predictors of therapeutic failure of occipital nerve stimulation in refractory chronic cluster headache.

BACKGROUND: Occipital nerve stimulation (ONS) is a treatment with evidence in refractory chronic cluster headache (CCH). However, the variable response rate and cost make it necessary to investigate predictors of response. METHODS: This is a cross-sectional study conducted through the review of medical records of CCH patients from six hospitals in Madrid. Epidemiological and clinical variables were compared between patients with ONS failure and the rest. ONS failure was defined as the need for device withdrawal or switch off because of lack of response or adverse events. RESULTS: From a series of 88 CCH, 26 (29.6%) underwent ONS surgery, of whom 13/26 (50.0%) failed because lack of response. ONS failure group had an earlier headache onset (mean ± SD) of 27.7 ± 6.9 vs. 36.7 ± 11.8 years, p = 0.026) and a higher smoking rate (100% vs. 42.9%, p = 0.006). Stational fluctuations (58.3% vs. 7.7%, p = 0.007) and nocturnal exacerbations (91.7% vs. 53.9%, p = 0.035) were more frequent in the ONS failure group as well. There was no difference between groups in diagnostic delay, years of evolution prior to surgery, mental illness, comorbidity with other headache disorders or chronic pain conditions or prior response to occipital nerves anesthetic blocks. CONCLUSIONS: Some clinical features such as an early debut, smoking and seasonal or circadian fluctuations could be related to failure of ONS in refractory CCH.

Assessing basic motor competences, physical fitness, and executive function in 4-5-year-old children: a longitudinal study in a primary care setting.

BACKGROUND: To evaluate the progression of physical fitness (PF), basic motor competence (BMC), and executive function (EF) over one year in children aged 4-5 years at a health center. METHODS: In this longitudinal analysis, children's BMC was evaluated using the MOBAK KG test for object and self-movement. The PREFIT Battery gauged PF through handgrip strength, standing long jump, and other fitness measures, while the Early Years Toolbox appraised EF. RESULTS: Adjustments for confounding factors showed notable improvements in BMC, particularly in object movement (OM; mean difference 0.789, p = 0.044) and self-movement (SM; mean difference 0.842, p = 0.037), with overall MOBAK scores also increasing (mean difference 1.632, p = 0.018). Enhancements in the standing long jump (mean difference 9.036 cm, p = 0.014) and EF tasks "Mr. Ant" (mean difference 0.669, p < 0.001) and "Go/No-Go" (mean difference 0.120, p < 0.001) were evident, signifying substantial BMC gains and some progress in PF and EF. CONCLUSION: This research underscores the positive impact of regular training on BMC and PF in young children. Significant BMC development and associated improvements in PF and EF over the study period highlight the importance of structured activities in early childhood. These findings advocate for standardized training programs to enhance childhood health and encourage active lifestyles. TRIAL REGISTRATION: NCT05741879. Registered February 14, 2023, Version 1.

Environmental Exposure to Persistent Organic Pollutants and Its Association with Endometriosis Risk: Implications in the Epithelial-Mesenchymal Transition Process.

We aimed to explore the relationship of adipose tissue concentrations of some persistent organic pollutants (POPs) with the risk of endometriosis and the endometriotic tissue expression profile of genes related to the endometriosis-related epithelial-mesenchymal transition (EMT) process. This case-control study enrolled 109 women (34 cases and 75 controls) between January 2018 and March 2020. Adipose tissue samples and endometriotic tissues were intraoperatively collected to determine concentrations of nine POPs and the gene expression profiles of 36 EMT-related genes, respectively. Associations of POPs with endometriosis risk were explored with multivariate logistic regression, while the relationship between exposure and gene expression profiles was assessed through Spearman correlation or Mann-Whitney U tests. After adjustment, increased endometriosis risk was associated with p,p'-DDT, PCB-180, and ΣPCBs. POP exposure was also associated with reduced gene expression levels of the CLDN7 epithelial marker and increased levels of the ITGB2 mesenchymal marker and a variety of EMT promoters (HMGA1, HOXA10, FOXM1, DKK1, CCR1, TNFRSF1B, RRM2, ANG, ANGPT1, and ESR1). Our findings indicate that exposure to POPs may increase the risk of endometriosis and might have a role in the endometriosis-related EMT development, contributing to the disease onset and progression. Further studies are warranted to corroborate these findings.

Virtual Reality Distraction for Needle-Related Pain and Distress in Children: A Multicenter Randomized Controlled Trial.

This international multicenter randomized controlled trial aimed to compare the effectiveness of virtual reality (VR) distraction with an identical non-VR game in reducing needle-related pain and anxiety in children undergoing venous blood draw. The study involved 304 children aged 5-9 years undergoing a blood draw procedure, randomly allocated to one of three groups: VR distraction, non-VR distraction, and control group (usual care). The distraction task was based on the Multiple Object Tracking (MOT) paradigm, and the game was identical in design and gameplay for both VR and non-VR distraction groups. The primary outcome was self-reported pain intensity using the Faces Pain Scale-Revised (FPS-R). Secondary outcomes included child distress, attention/distraction to the blood draw, and parent and medical staff satisfaction with procedure. Analyses were conducted using analysis of variance and multivariable linear regression models. The results showed that VR distraction and non-VR distraction performed similarly, showing large effect sizes compared with standard care. There was no significant difference between the two types of distraction. The study's findings suggest that VR and non-VR distraction are similarly effective in reducing needle-related pain and anxiety in children undergoing venous blood draw. This is the first well-powered study comparing modern VR distraction with an identical task displayed on a smartphone or monitor screen. The study's results have important implications for using VR in clinical settings and suggest that investing in expensive VR equipment for acute pain management may not be necessary. The study protocol was pre-registered on Open Science Framework at https://osf.io/frsyc.

Factors associated with recovery during schizophrenia and related disorders: A review of meta-analysis.

BACKGROUND: The spectrum of schizophrenia disorders (SSD) is a severe mental disorder. It is one of the main medical causes of disability that generates high health and social costs. OBJECTIVE: To analyze the factors associated with clinical recovery (CR) (symptomatic remission-SR and functional recovery-FR) and personal recovery (PR) in people diagnosed with SSD. METHODS: 14 meta-analyses focused on recovery were reviewed following the PRISMA model statements. 95 % of CI was established. RESULTS: Shorter Duration of Untreated Psychosis (Zr = 0.24, [0.17, 0.30]) and total Duration of Untreated Illness (Zr = 0.34, [0.20, 0.48]) were related to greater SR and general functioning, respectively. Resilience was the variable with the greatest effect on FR (Zr = 0.67, [0.63, 0.71]). Premorbid adjustment (Zr = 0.34, [0.18, 0.49]) and physical intervention (Zr = 0.71, [0.55, 0.86]) had the greatest effect on occupational and social functioning, respectively. Less severe affective symptoms were related to greater PR (Zr = 0.46, [0.42, 0.50]). There are differences between affective SR and the other types of SR (Zr(SR-A - SR-) = 0.13, Qb = 6.51, p = 0.011), (Zr(SR-A - SR+) = 0.20, Qb = 8.52, p = 0.004), (Zr(SR-A - SR) = 0.18, Qb = 19.29, p = 0.0001). In all, resilience was associated with greater recovery (Zr = 0.67, [0.53, 0.80]), with the global effect being greater on PR than on CR (Zr(PR-CR) = 0.07, Qb = 3.45, p = 0.05). CONCLUSIONS: Resilience was the variable most strongly associated with recovery. Symptomatic or functional improvement obtained less statistical weight.

Examining the effects of pleasantness ratings on correct and false recognition in the DRM paradigm: accuracy, recollection and familiarity estimates.

Distinctive encoding usually increases correct recognition while also producing a reduction in false recognition. In the Deese-Roediger-McDermott (DRM) illusion this phenomenon, called the mirror effect, occurs when participants focus on unique features of each of the words in the study list. In previous studies, the pleasantness rating task, used to foster distinctive encoding, generated different patterns of results. The main aim of our research is to examine under what circumstances this task can produce the mirror effect in the DRM paradigm, based on evidence from recognition accuracy and subjective retrieval experience. In Experiment 1, a standard version (word pleasantness rating on a 5-point Likert-type scale) was used for comparison with two other encoding conditions: shallow processing (vowel identification) and a read-only control. The standard task, compared to the other conditions, increased correct recognition, but did not reduce false recognition, and this result may be affected by the number of lists presented for study. Therefore, in experiment 2, to minimize the possible effect of the so-called retention size, the number of studied lists was reduced. In addition, the standard version was compared with a supposedly more item-specific version (participants rated the pleasantness of words while thinking of a single reason for this), also including the read-only control condition. In both versions of the pleasantness rating task, more correct recognition is achieved compared to the control condition, with no differences between the two versions. In the false recognition observed here, only the specific pleasantness rating task achieved a reduction relative to the control condition. On the other hand, the subjective retrieval experience accompanied correct and false recognition in the various study conditions. Although the standard pleasantness rating task has been considered to perform item-specific processing, our results challenge that claim. Furthermore, we propose a possible boundary condition of the standard task for the reduction of false recognition in the DRM paradigm.

Cultural adaptation, validation and evaluation of the psychometric properties of Childbirth Experience Questionnaire version 2.0 in the Spanish context.

BACKGROUND: Several instruments have been designed to assess the childbirth experience. The Childbirth Experience Questionnaire (CEQ) is one of the most widely used tools. There is an improved version of this instrument, the Childbirth Experience Questionnaire (CEQ 2.0), which has not been adapted or validated for use in Spain. The aim of present study is to adapt the CEQ 2.0 to the Spanish context and evaluate its psychometric properties. METHODS: This research was carried out in 2 stages. In the first stage, a methodological study was carried out in which the instrument was translated and back-translated, content validity was assessed by 10 experts (by calculating Aiken's V coefficient) and face validity was assessed in a sample of 30 postpartum women. In the second stage, a cross-sectional study was carried out to evaluate construct validity by using confirmatory factor analysis, reliability evaluation (internal consistency and temporal stability) and validation by known groups. RESULTS: In Stage 1, a Spanish version of the CEQ 2.0 (CEQ-E 2.0) was obtained with adequate face and content validity, with Aiken V scores greater than 0.70 for all items. A final sample of 500 women participated in Stage 2 of the study. The fit values for the obtained four-domain model were RMSEA = 0.038 [95% CI: 0.038-0.042], CFI = 0.989 [95% CI: 0.984-0.991], and GFI = 0.990 [95% CI: 0.982-0.991]. The overall Omega and Cronbach's Alpha coefficients were 0.872 [95% CI: 0.850-0.891] and 0.870 [95% CI: 0.849-0.890] respectively. A coefficient of intraclass correlation of 0.824 [95% CI: 0.314-0.936] (p ≤ 0.001) and a concordance coefficient of 0.694 [95% CI: 0.523-0.811] were obtained. CONCLUSIONS: The Spanish version of CEQ 2.0 (CEQ-E 2.0), has adequate psychometric properties and is a valid, useful, and reliable instrument for assessing the childbirth experience in Spanish women.

Evaluation of the concomitant use of prophylactic treatments in patients with migraine under anti-calcitonin gene-related peptide therapies: The PREVENAC study.

BACKGROUND AND PURPOSE: Anti-calcitonin gene-related peptide (CGRP) therapies are recent preventive therapies approved for both episodic and chronic migraine. One of the measures of effectiveness is the withdrawal of other preventive treatments. The objective of this study is to quantify the impact of anti-CGRP drugs in concomitant preventive treatment in patients with migraine. METHODS: This was an observational, retrospective, multicenter cohort study with patients from nine national headache units. Patients with migraine undergoing treatment for at least 6 months with anti-CGRP antibodies, who were initially associated with some preventive treatment (oral and/or onabotulinumtoxinA) were included. Demographic and clinical variables were collected, as well as variables related to headache. Differences according to withdrawal or nonwithdrawal were evaluated. RESULTS: A total of 408 patients were included, 86.52% women, 48.79 (SD = 1.46) years old. Preventive treatment was withdrawn in 43.87% (179/408), 20.83% partially and 23.04% totally. In 27.45% (112/408), it was maintained exclusively due to comorbidity and in 28.6% (117/408) due to partial efficacy. The most frequent time of withdrawal was between 3 and 5 months after the start of treatment. The baseline characteristics associated with nonwithdrawal were comorbidities: insomnia, hypertension and obesity, chronic migraine, and medication overuse. In the multivariate analysis, the absence of high blood pressure, a greater number of preventive treatments at the start, and a lower number of migraine days/month after anti-CGRP treatment were independently associated with withdrawal of the treatment (p < 0.05). CONCLUSIONS: Anti-CGRP antibodies allow the withdrawal of associated preventive treatment in a significant percentage of patients, which supports its effectiveness in real-life conditions.

RE-START: Exploring the effectiveness of anti-calcitonin gene-related peptide resumption after discontinuation in migraine.

BACKGROUND AND PURPOSE: According to the latest European guidelines, discontinuation of monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP MAb) may be considered after 12-18 months of treatment. However, some patients may worsen after discontinuation. In this study, we assessed the response following treatment resumption. METHODS: This was a prospective study conducted in 14 Headache Units in Spain. We included patients with response to anti-CGRP MAb with clinical worsening after withdrawal and resumption of treatment. Numbers of monthly migraine days (MMD) and monthly headache days (MHD) were obtained at four time points: before starting anti-CGRP MAb (T-baseline); last month of first treatment period (T-suspension); month of restart due to worsening (T-worsening); and 3 months after resumption (T-reintroduction). The response rate to resumption was calculated. Possible differences among periods were analysed according to MMD and MHD. RESULTS: A total of 360 patients, 82% women, with a median (interquartile range [IQR]) age at migraine onset of 18 (12) years. The median (IQR) MHD at T-baseline was 20 (13) and MMD was 5 (6); at T-suspension, the median (IQR) MHD was 5 (6) and MMD was 4 (5); at T-worsening, the median (IQR) MHD was 16 (13) and MMD was 12 (6); and at T-reintroduction, the median (IQR) MHD was 8 (8) and MHD was 5 (5). In the second period of treatment, a 50% response rate was achieved by 57.4% of patients in MHD and 65.8% in MMD. Multivariate models showed significant differences in MHD between the third month after reintroduction and last month before suspension of first treatment period (p < 0.001). CONCLUSION: The results suggest that anti-CGRP MAb therapy is effective after reintroduction. However, 3 months after resumption, one third of the sample reached the same improvement as after the first treatment period.

Marinomonas mediterranea synthesizes an R-type bacteriocin.

Prophages integrated into bacterial genomes can become cryptic or defective prophages, which may evolve to provide various traits to bacterial cells. Previous research on Marinomonas mediterranea MMB-1 demonstrated the production of defective particles. In this study, an analysis of the genomes of three different strains (MMB-1, MMB-2, and MMB-3) revealed the presence of a region named MEDPRO1, spanning approximately 52 kb, coding for a defective prophage in strains MMB-1 and MMB-2. This prophage seems to have been lost in strain MMB-3, possibly due to the presence of spacers recognizing this region in an I-F CRISPR array in this strain. However, all three strains produce remarkably similar defective particles. Using strain MMB-1 as a model, mass spectrometry analyses indicated that the structural proteins of the defective particles are encoded by a second defective prophage situated within the MEDPRO2 region, spanning approximately 13 kb. This finding was further validated through the deletion of this second defective prophage. Genomic region analyses and the detection of antimicrobial activity of the defective prophage against other Marinomonas species suggest that it is an R-type bacteriocin. Marinomonas mediterranea synthesizes antimicrobial proteins with lysine oxidase activity, and the synthesis of an R-type bacteriocin constitutes an additional mechanism in microbial competition for the colonization of habitats such as the surface of marine plants.IMPORTANCEThe interactions between bacterial strains inhabiting the same environment determine the final composition of the microbiome. In this study, it is shown that some extracellular defective phage particles previously observed in Marinomonas mediterranea are in fact R-type bacteriocins showing antimicrobial activity against other Marinomonas strains. The operon coding for the R-type bacteriocin has been identified.

Effectiveness, tolerability, and response predictors of preventive anti-CGRP mAbs for migraine in patients over 65 years old: a multicenter real-world case-control study.

OBJECTIVE: To evaluate clinical characteristics, effectiveness, and tolerability of preventive anti- calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) in the elderly. Anti-CGRP mAbs have demonstrated efficacy and safety in patients with migraine although there is limited information regarding the elderly. DESIGN: We performed a multicenter case-control study of cases (patients over 65 years old) and controls (sex-matched patients under 55 years old) with migraine receiving anti-CGRP mAbs. METHODS: We included the demographic characteristics, effectiveness-reduction in the number of monthly headache days (MHD) and monthly migraine days (MMD), 30%, 50%, and 75% responder rates-and treatment emergent adverse events (TEAEs). The primary endpoint was the 50% response rate regarding MHD at weeks 20-24; exploratory 50% response predictors in the elderly were evaluated. RESULTS: In total, 228 patients were included: 114 cases , 114 controls-. Among cases 84.2% (96/114) were women, 79.8% (91/114) CM; mean age of cases 70.1 years old (range: 66-86); mean age of controls was 42.9 years old(range: 38-49). Cases had a higher percentage of vascular risk factors (P < .05),older age of onset (P < .001) and more reported prior preventive treatments (P < .001). Regarding effectiveness in cases, 50% response rate was achieved by 57.5% (42/73) at 20-24 weeks, with lower reduction in the MHD at 8-12 weeks (5 [7.2], 8 [9.1]; P = .001) and a higher reduction in MMD at 20-24 weeks (10.7 [9.1], 9.2 [7.7]; P = .04) compared to the control group. The percentage of TEAEs was similar in the 2 groups. Diagnosis of episodic migraine (EM) (P = .03) and lower number of MHD at baseline (P = .001) were associated with a 50% response in the elderly in univariate analysis. CONCLUSIONS: Our study provides real world evidence of effectiveness and safety of anti-CGRP mAbs for migraine in patients without upper age-limit and possible predictors of anti-CGRP response in the elderly.

Is the Presence of Levator Ani Muscle Avulsion Relevant for the Diagnosis of Uterine Prolapse?

OBJECTIVE: To determine if the addition of the assessment of levator ani muscle (LAM) avulsion to the measurement of the difference in the pubis-uterine fundus distance between rest and with the Valsalva maneuver could increase the diagnostic capacity of ultrasound for uterine prolapse (UP). METHODS: This multicenter, observational and prospective study included 145 patients. Ultrasound assessment was performed, establishing the diagnosis of UP as a difference between the pubic-uterine fundus distance at rest and during the Valsalva maneuver ≥15 mm (standard technique), while LAM avulsion was defined as an abnormal LAM insertion in three central slices using multislice ultrasound. A binary multivariate logistic regression model was made using nonautomated methods to predict surgical UP (general population, premenopausal, and postmenopausal patients), including the difference between the pubis-uterine fundus distance at rest and with the Valsalva maneuver as well as LAM avulsion. RESULTS: A total of 143 patients completed the study. The addition of LAM avulsion criteria to the standard dynamic distance-based protocol for the diagnosis of UP resulted in a higher sensitivity for the general population (79.7 vs 68.1%) as well as for premenopausal (89.3 vs 79.9%) and postmenopausal patients (76 vs 66.1%). In contrast, the standard technique showed a higher specificity than the model based on the standard technique associated with LAM avulsion for the general population (89.2 vs 74.3%) and premenopausal women (91.7 vs 63.2%). For postmenopausal patients, the model based on the standard technique associated with LAM avulsion had a higher sensitivity (76 vs 66.1%) and specificity (91.7 vs 86.8%) than the ultrasound diagnosis of UP. CONCLUSION: The implementation of the assessment of LAM avulsion in the ultrasound diagnosis of UP is useful in postmenopausal patients, increasing sensitivity and specificity relative to the ultrasound assessment based only on the difference between the pubis-uterine fundus distance at rest and with the Valsalva maneuver.