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Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke. In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20–35 vs 36–50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The VNS group received 0·8 mA, 100 μs, 30 Hz stimulation pulses, lasting 0·5 s. The control group received 0 mA pulses. Participants received 6 weeks of in-clinic therapy (three times per week; total of 18 sessions) followed by a home exercise programme. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT03131960. Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5·0 points (SD 4·4) in the VNS group and by 2·4 points (3·8) in the control group (between group difference 2·6, 95% CI 1·0–4·2, p=0·0014). 90 days after in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%, 6–41; p=0·0098). There was one serious adverse event related to surgery (vocal cord paresis) in the control group. Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke. MicroTransponder.

Objective To determine the association between surgeons’ experience and postoperative complications in thyroid surgery.Design Prospective cross sectional multicentre study.Setting High volume referral centres in five academic hospitals in France.Participants All patients who underwent a thyroidectomy undertaken by every surgeon in these hospitals from 1 April 2008 to 31 December 2009.Main outcome measures Presence of two permanent major complications (recurrent laryngeal nerve palsy or hypoparathyroidism), six months after thyroid surgery. We used mixed effects logistic regression to determine the association between length of experience and postoperative complications. Results 28 surgeons completed 3574 thyroid procedures during a one year period. Overall rates of recurrent laryngeal nerve palsy and hypoparathyroidism were 2.08% (95% confidence interval 1.53% to 2.67%) and 2.69% (2.10% to 3.31%), respectively. In a multivariate analysis, 20 years or more of practice was associated with increased probability of both recurrent laryngeal nerve palsy (odds ratio 3.06 (1.07 to 8.80), P=0.04) and hypoparathyroidism (7.56 (1.79 to 31.99), P=0.01). Surgeons’ performance had a concave association with their length of experience (P=0.036) and age (P=0.035); surgeons aged 35 to 50 years had better outcomes than their younger and older colleagues.Conclusions Optimum individual performance in thyroid surgery cannot be passively achieved or maintained by accumulating experience. Factors contributing to poor performance in very experienced surgeons should be explored further.

Consensus is lacking as to whether routine screening and treatment for gestational diabetes mellitus is warranted. This large randomized trial of the treatment of gestational diabetes demonstrated that serious perinatal complications were significantly less common among the offspring of women who received dietary advice, blood glucose monitoring, and insulin therapy as needed to maintain glycemic control than among the offspring of women who received routine care. This trial demonstrated that serious perinatal complications were significantly less common among the offspring of women who received screening and treatment for gestational diabetes mellitus than among the offspring of women who received routine care. Gestational diabetes mellitus occurs in 2 to 9 percent of all pregnancies 1 , 2 and is associated with substantial rates of maternal and perinatal complications. The risk of perinatal mortality is not increased, 3 but the risk of macrosomia is. Other perinatal risks include shoulder dystocia, birth injuries such as bone fractures and nerve palsies, and hypoglycemia. Long-term adverse health outcomes reported among infants born to mothers with gestational diabetes include sustained impairment of glucose tolerance, 4 subsequent obesity 5 (although not when adjusted for size 6 ), and impaired intellectual achievement. 7 For women, gestational diabetes is a strong risk factor for diabetes. 8 Although the . . .

Objective: Promptly treated erythema migrans (EM) has good prognosis. However, some patients report persistent symptoms. Do patients with EM have more symptoms than the general population? We describe individual symptoms and general function in EM-patients at time of diagnosis and one year after treatment. Design: Prospective study with 1-year follow up after treatment. Questionnaires included a modified version of the Subjective Health Complaints Inventory, comprising three additional Lyme borreliosis (LB) related symptoms. General function was assessed using a five-point scale modified from the COOP/WONCA charts. Setting: Norwegian general practice. Subjects: A total of 188 patients were included in a randomized controlled trial comparing three antibiotic regimens for EM, of whom 139 had complete data for this study. Main outcome measures: Individual symptoms, symptom load and general function. Results: Mild symptoms were common, reported by 84.9% at baseline and by 85.6% at follow-up. At baseline, patients reported a mean of 5.4 symptoms, compared with 6.2 after one year. Severely bothersome symptoms and severely impaired general function were rare. Tiredness was the most reported symptom both at baseline and at follow-up. Palsy (other than facial) was the least reported symptom, but the only one with a significant increase. However, this was not associated to the EM. Conclusion: The symptom load was comparable to that reported in the general population. We found an increase in symptom load at follow-up that did not significantly affect general function. Implication: Monitoring patients' symptom loads prior to treatment reduce the probability of attributing follow-up symptoms to LB. Key points Erythema migrans has a good prognosis.Patients treated for erythema migrans have a slight increase in symptom load one year after treatment. This increase does not affect general function. The levels of subjective health complaints in patients treated for erythema migrans are comparable to the background population.

Purpose There are no randomized trials comparing the incidence or severity of facial nerve dysfunction after superficial parotidectomy with or without continuous intraoperative electromyographic neuromonitoring. This pilot study aimed to assess the variability in outcomes to help determine the needs and possible ethical issues in a full-scale study. Methods Prospective randomized pilot study comparing the incidence and grade of facial nerve dysfunction among 106 patients subjected to superficial parotidectomy with or without continuous four channels electromyographic neuromonitoring (52 monitored patients and 54 controls). Results The incidences of immediate (38.3% vs. 51.8%, p  = 0.1) and late facial dysfunction, up to 180 days following surgery, (3.8% vs. 5.5%, p  = 0.4) were similar between monitored patients and controls. Immediate facial nerve dysfunction with a House–Brackmann ≥ grade III was more frequent among the non-monitored patients (57.8% vs. 30%, p  = 0.2), and outcomes were significantly poorer in this group (mean sum score of 68.7 vs. 81.5, p  = 0.002), when assessed with the regional Sunnybrook scale. A full-scale prospective randomized study to detect a significant reduction in the incidence of immediate facial nerve dysfunction with the use of continuous intraoperative electromyographic neuromonitoring, with 80% power and a 5% significant level, would require 560 patients allocated to the monitored and control groups. Considering a mean rate of 30 patients/year/center, such a study would require the participation of five centers for 4 years. Conclusions In the present pilot study, the incidences of immediate and late facial nerve dysfunction were similar between patients with benign parotid tumors subjected to superficial parotidectomy with or without continuous intraoperative electromyographic neuromonitoring. However, immediate facial dysfunction was more severe among the non-monitored patients.

Purpose Interscalene brachial plexus block (interscalene block) complications usually depend on the dose administered. The objective of this study was to determine whether ultrasound-guided interscalene block with a 5-mL dose of 0.75% ropivacaine would have sufficient analgesic efficacy after shoulder arthroscopic surgery when compared with a 10-mL dose. Methods Patients undergoing arthroscopic rotator cuff repair surgery ( n  = 60) were assigned randomly to one of two groups receiving 5 mL (Group 5) or 10 mL (Group 10) of 0.75% ropivacaine. Ultrasound-guided interscalene block was performed using the in-plane technique, and general anesthesia was administered. Time to first analgesic request was recorded, and the following issues were assessed in the postanesthesia care unit at six, 12, 24, and 48 hr postoperatively: postoperative pain as determined by a visual analogue scale (VAS), patient satisfaction, hemidiaphragmatic paralysis, other block-related complications, and postoperative nausea and vomiting (PONV). Results There was no significant difference between groups in time to first analgesic requirement (median [interquartile range] for Group 5: 16 [12-48] hr, Group 10: 18 [12-48] hr; P  = 0.907). The postoperative pain VAS score was similar in both groups. The incidence of hemidiaphragmatic paralysis on postoperative chest x-ray was 33% in Group 5 and 60% in Group 10 ( P  = 0.035). However, the incidences of other block-related complications, PONV, and patient satisfaction were not significantly different between groups. Conclusion Interscalene block performed under ultrasound guidance with 0.75% ropivacaine 5 mL showed analgesic efficacy similar to that with 0.75% ropivacaine 10 mL, but with a lower incidence of hemidiaphragmatic paralysis.

Neuromuscular block results in the loss of muscular tone in the upper airway, which might contribute to the increased postoperative airway morbidity followed by ProSeal laryngeal mask airway (PLMA) insertion. We compared the pharyngolaryngeal discomfort exerted by the PLMA according to the neuromuscular block. One hundred sixty patients undergoing surgery for breast disease or inguinal hernia were anesthetized with propofol and remifentanil by target controlled infusion. Rocuronium 0.6 mg/kg (NMBA group, n = 80) or normal saline (No-NMBA group, n = 80) was administered after the loss of consciousness, and one anesthesiologist inserted the PLMA. Postoperative pharyngolaryngeal discomfort was evaluated at postoperative 1 h. Traumatic event was recorded based on the blood trace on the surface of the PLMA cuff. Insertion time, insertion attempt number, sealing pressure, and fiberoptic brochoscopic grades were evaluated. Patients' characteristics and the PLMA insertion condition (insertion time, successful insertion attempt number, fiberoptic bronchoscopic grade, and sealing pressure) were similar between the two groups. The PLMA can be successfully inserted in non-paralyzed patients with less postoperative pharyngolaryngeal discomfort than when a neuromuscular blocking agent is used (13.8% vs. 30.0%, P = 0.021). The incidence of traumatic events is also reduced when no neuromuscular blocking agent is used (16.3% vs. 32.5%, P = 0.026). Regardless of whether or not a surgical procedure requires muscular relaxation, there is no need to administer neuromuscular blocking agents solely for the purpose of PLMA insertion.

This study examined the effect of neurodevelopmental treatment (NDT) and differences in its intensity on gross motor function of children with cerebral palsy (CP). Participants were 34 children (12 females, 22 males; mean age 7y 3mo [SD 3y 6mo], age range 3 to 14y) with mild to moderate spasticity and hemiplegia (n=10), diplegia (n=12), and tetraplegia (n=12). Gross Motor Function Classification System levels were: I (n=10), II (n=10), and III (n=14). The paired sample, which was obtained by ratio stratification and matching by sex, age, and distribution of impairment from a total of 114 children with CP, was assigned randomly to two groups: group A underwent NDT twice a week and group B five times a week for 16 weeks. The outcome measure used was the Gross Motor Function Measure, which assessed the performance of the children before and after intervention. The paired-sample t-test revealed that gross motor function of children from both groups improved significantly after intervention (p<0.05). Children in group B performed better and showed significantly greater improvement than those in group A (p<0.05). Results support the effectiveness of NDT and underline the need for intensive application of the treatment.

Clusters of acute flaccid paralysis or cranial nerve dysfunction in children are uncommon. We aimed to assess a cluster of children with acute flaccid paralysis and cranial nerve dysfunction geographically and temporally associated with an outbreak of enterovirus-D68 respiratory disease. We defined a case of neurological disease as any child admitted to Children's Hospital Colorado (Aurora, CO, USA) with acute flaccid paralysis with spinal-cord lesions involving mainly grey matter on imaging, or acute cranial nerve dysfunction with brainstem lesions on imaging, who had onset of neurological symptoms between Aug 1, 2014, and Oct 31, 2014. We used Poisson regression to assess whether the numbers of cases during the outbreak period were significantly greater than baseline case numbers from a historical control period (July 31, 2010, to July 31, 2014). 12 children met the case definition (median age 11·5 years [IQR 6·75–15]). All had a prodromal febrile illness preceding neurological symptoms by a median of 7 days (IQR 5·75–8). Neurological deficits included flaccid limb weakness (n=10; asymmetric n=7), bulbar weakness (n=6), and cranial nerve VI (n=3) and VII (n=2) dysfunction. Ten (83%) children had confluent, longitudinally extensive spinal-cord lesions of the central grey matter, with predominant anterior horn-cell involvement, and nine (75%) children had brainstem lesions. Ten (91%) of 11 children had cerebrospinal fluid pleocytosis. Nasopharyngeal specimens from eight (73%) of 11 children were positive for rhinovirus or enterovirus. Viruses from five (45%) of 11 children were typed as enterovirus D68. Enterovirus PCR of cerebrospinal fluid, blood, and rectal swabs, and tests for other causes, were negative. Improvement of cranial nerve dysfunction has been noted in three (30%) of ten children. All ten children with limb weakness have residual deficits. We report the first geographically and temporally defined cluster of acute flaccid paralysis and cranial nerve dysfunction in children associated with an outbreak of enterovirus-D68 respiratory illness. Our findings suggest the possibility of an association between enterovirus D68 and neurological disease in children. If enterovirus-D68 infections continue to happen in an endemic or epidemic pattern, development of effective antiviral or immunomodulatory therapies and vaccines should become scientific priorities. National Center for Advancing Translational Sciences, National Institutes of Health.