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Background Coma is one of the frequently encountered clinical conditions in any intensive care unit (ICU), which is responsible for considerable morbidity and mortality. Therefore, this study was designed to look at the clinical and EEG profile of Nonconvulsive Status Epilepticus (NCSE) in comatose ICU patients using portable electroencephalography (EEG). Methods In all 102 patients of unresponsive coma (GCS ≤ 8), who remained in poor sensorium despite 48 h of optimum treatment in ICU, were included in the study. All patients underwent 1 h of electroencephalography (EEG) monitoring with a portable EEG machine. All EEGs were screened according to Salzburg Consensus Criteria (SCC) for Nonconvulsive Status Epilepticus (NCSE). Patients with evidence of NCSE were administered parenteral Antiepileptic Drugs (AED). A repeat EEG was done after 24 h of baseline to ascertain the effect of AED. The primary outcome was the recognition of patients with NCSE on the basis of established EEG criteria. The secondary outcome measure was the Glasgow outcome scale (GOS) at the time of discharge. Results Out of 102 cases enrolled, 12 (11.8%) cases were detected to have NCSE on portable EEG. The mean age of patients with NCSE was 52.2 years. In terms of gender distribution, 2/12 (17%) were female, and 10/12 (83%) were male (M: F = 5:1). Median GCS was 6 (range 3–8). Looking at CNS infections, 4/12 (33.3%) had evidence of some form of CNS infection in the NCSE group, compared to 16/90 (18%) in the group without NCSE. This difference was statistically significant (P-value 2 points) after administration of AED’ was noted with good clinical outcomes (GOS 5). In five of these 12 cases, death was the final outcome (GOS 1). Conclusions NSCE should be considered in the differential diagnosis of all unresponsive comatose ICU patients. In resource-limited settings, where continuous EEG monitoring may not be feasible, bedside portable EEG testing can be used to diagnose patients with NCSE. Treating NCSE reverses epileptiform EEG changes and improves clinical outcomes in a subset of comatose ICU patients.

OBJECTIVES: To assess the level of agreement between patient-reported pain using a standardized pain map and the physician-determined clinical diagnosis of Achilles tendinopathy.DESIGN: Cross-sectional study.METHODS: Eligible patients were adults visiting a sports physician for symptoms in the Achilles tendon region. Patients completed a digital questionnaire and indicated one location on a pain map where they experienced their pain. The primary outcome measure was level of agreement (% and Kappa coefficient) between patient-reported pain on the pain map and the physician-determined clinical diagnosis (defined as localized pain associated with tendon-loading activities and pain on palpation with or without tendon thickening). The secondary outcome measure was the agreement between the location on the pain map (midportion/insertional region) with the clinical diagnosis of midportion/insertional Achilles tendinopathy.RESULTS: 110 patients (mean (SD) age 48 (13), 61% men) with pain in the Achilles region were included. In 102 (93%, Kappa = 0.86, CI 0.78-0.95) patients who indicated pain in the Achilles tendon region on the pain map, the clinical diagnosis of Achilles tendinopathy was made by the sports physician. 82% of the patients had the clinical diagnosis of tendinopathy in the specific region of the tendon they marked on the pain map (Kappa = 0.67, CI 0.54-0.79).CONCLUSIONS: There is almost perfect agreement between patient-reported pain on a pain map and a physician-established clinical diagnosis of Achilles tendinopathy. There was substantial agreement between the localization of the pain that was selected by the patient and the diagnosis of insertional/midportion Achilles tendinopathy by the physician. This tool could potentially aid in adequate triage for specialized care and for researchers performing large epidemiological studies.

Introduction Phase 3 study MCI186-19 demonstrated less loss of physical function with edaravone versus placebo, as measured by the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score. A 1-point drop in an individual ALSFRS-R item may be clinically meaningful. We assessed ALSFRS-R item score changes to identify clinical features protected by edaravone treatment. Methods Time-to-event analysis was used to assess the cumulative probabilities of reductions in ALSFRS-R item scores and Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) subdomain scores. Results Edaravone use was accompanied by: [1] delayed drop of ≥1 point in ALSFRS-R item score for 4 items: salivation, walking, climbing stairs, orthopnea (unadjusted), or for 2 items: walking, climbing stairs (after Bonferroni correction for multiple comparisons); [2] delayed score transition from 4 or 3 at baseline to ≤2 for 5 items: swallowing, eating motion, walking, climbing stairs, orthopnea (unadjusted), or for 1 item: climbing stairs (after Bonferroni correction for multiple comparisons); and [3] delayed worsening of ALSAQ-40 domain scores representing daily living/independence, eating and drinking (unadjusted). Discussion These post-hoc analyses identified the ALSFRS-R item scores and ALSAQ-40 domain scores that were associated with preserved gross motor function and health-related quality of life, respectively, after edaravone treatment. Limitations of post-hoc analyses should be considered when interpreting these results. We recommend that clinical trials employing the ALSFRS-R include this type of analysis as a pre-specified secondary outcome measure.

Introduction Minimally invasive surgical techniques have become routinely applied in the evaluation and treatment of patients with isolated traumatic diaphragmatic injuries (TDI). However, there remains a paucity of data that compares the laparoscopic repair to the open repair approach. The aim of our study is to examine patient outcomes between TDI patients managed laparoscopically versus those managed using open repair. Methods Adult (age ≥18 years) trauma patients presenting with TDI that required surgical repair were identified in the Trauma Quality Improvement Program database 2017. Patients were excluded if they underwent any other surgical procedure of the abdomen or chest. Patients were then stratified into 2 groups based on the surgical approach: laparoscopic repair of the diaphragm versus open repair. Propensity-score matching in a 1:2 ratio was performed. Primary outcome measures were in-hospital major complications and length of stay (LOS). Secondary outcome measure was in-hospital mortality. Results A total of 177 adult trauma patients who had a laparoscopic repair of their isolated diaphragmatic injury were matched to 354 patients who had an open repair. Mean age was 35 ± 16 years, 78% were male, and mean BMI was 27 ± 7 kg/m2. 67 percent of the patients had penetrating injuries, and the median ISS was 17 [9-21]. CT imaging was done in 67% of the patients, with 71% presenting with left-sided injury and 21% having visceral herniation. Conversion from laparoscopic to open was reported in 7.3% of the cases. Patients with a laparoscopic repair had significantly lower rates of major complications (5.6 versus 14.4%; P Conclusion Laparoscopic repair of traumatic diaphragmatic injury was associated with decreased morbidity and a shorter hospital course, with a low conversion rate to open repair. Future studies remain necessary to further explore the long-term outcomes of patients with such injury. Level of Evidence Level III Study Type Therapeutic

Background Painful diabetic peripheral neuropathy (PDPN) has a great impact on an individual’s quality of life. The current researchers’ previous trial suggested that acupuncture was a promising adjunctive treatment for PDPN. However, the underlying mechanism of action of acupuncture treatment for PDPN is still unclear, especially its effects at the cerebral level. The aim of this trial will be to explore how acupuncture works in treating PDPN by using multimodal cerebral imaging. Method and design This will be a randomized controlled trial. A total of 150 participants will be recruited and assigned to one of three groups: the healthy group, the DM without PDPN group and the DM with PDPN group. Participants in the DM without PDPN and the DM with PDPN groups will each be further divided between an electroacupuncture group and a sham electroacupuncture group. Participants will receive six treatment sessions per week for 4 weeks. Multimodal cerebral imaging includes resting-state functional magnetic resonance imaging (rs-fMRI), diffusion tensor imaging (DTI) and magnetic resonance spectroscopy (MRS); this neurophysiological testing will be the primary outcome measure. Subjective pain scales and blood analysis will be a secondary outcome measure and will be used to assess the clinical efficacy of the intervention. Multimodal cerebral imaging will be used to detect cerebral activity changes in each treatment group. The clinical data and fMRI data will be analysed for all the groups. Multiple correlation regression analyses will be used to assess the association between changes in cerebral functional activity and the improvement of clinical outcomes after acupuncture treatment. Discussion This study is based on the results of the researchers’ previous study, and using combined clinical and cerebral function changes, it will help evaluate the effects of acupuncture on PDPN. The investigation of acupuncture’s central mechanism of action will further expand the understanding of acupuncture treatment of PDPN. Trial registration Chinese Clinical Trial Registry ChiCTR1900024109. Registered on 26 June 2019.

Background Idiopathic pulmonary fibrosis (IPF) is one of the common types of interstitial lung disease having high prevalence and mortality worldwide. As a result of patient-centred hindering factors of adherence to centre-based pulmonary rehabilitation (PR), home-based PR is an alternate mode of rehabilitating individuals with IPF. This systematic review will evaluate the effectiveness of unsupervised home-based PR on functional capacity and health-related quality of life (HRQoL) in individuals with IPF. Methods Clinically stable, high resolution computed tomography and physician diagnosed IPF participants having modified Medical Research Council score below 5 will be considered for the systematic review. Studies involving home-based PR as an intervention to treat individuals with IPF will be considered. Randomised controlled trials and quasi-randomised studies (with two groups followed up) are eligible to be included. Outcomes of our interest are functional capacity (6-min walk distance, shuttle walk test and incremental shuttle walk test) and secondary outcome measure would include assessment of quality of life and adverse effects of intervention. Electronic databases such as SCOPUS, Medline (PubMed and Web of Science), PEDRo and CINAHL will be searched using database specific terms. Additionally, forward and backward citations of included studies will be searched to identify potential records. Two review authors, independently, will conduct the screening, data extraction using a customised standard tool, and critical appraisal using Cochrane Risk of Bias 2 tool of included studies. If data permits, meta-analysis will be conducted. In case of substantial heterogeneity, we will do a narrative synthesis. Subgroup analysis will be undertaken based on various contextual and interventional factors. Discussion This review will provide comprehensive evidence on the effectiveness of unsupervised home-based PR to physiotherapists, policy makers and researchers who are interested in IPF management. Findings from this review may guide the development and evaluation of more robust evidence based home-based PR that aimed to improve functional capacity among people with IPF. Systematic review registration PROSPERO CRD42020213883.

INTRODUCTION To improve compliance with voiding diaries in children with primary monosymptomatic nocturnal enuresis (PMNE), a new modified 3-day weekend frequency-volume chart (FVC) was designed, and the compliance and validity of this modified FVC was evaluated by comparing with the International Children's Continence Society (ICCS) recommended voiding diary. METHODS A total of 1200 patients with PMNE were enrolled in the study from 13 centers in China and were randomly assigned to record this modified FVC or the ICCS-recommended voiding diary. The primary outcome measure was the compliance, assessed by comparing the completing index and the quality score of diaries between two groups. The secondary outcome measure was the validity, evaluated by comparing the constituent of subtypes, micturition parameters and response rate to desmopressin. RESULTS Among the 1200 participants enrolled in the study, 447 patients completed the ICCS-recommended voiding diary and 469 completed the modified diary. The diurnal completing index and the quality score of the modified FVC group were better than those of the ICCS group. In addition, there was no significant difference between these two groups in the subtype classification, or in the response rate to desmopressin. CONCLUSIONS The modified FVC could be applied to obtain the voiding characteristics of children with PMNE as the ICCS-recommended voiding diary does and offers a reasonable and better choice for children with PMNE from the unselected population in the future.

Objective. Examining the effects of a pulmonary rehabilitation (PR) program applied to patients undergoing coronary artery bypass grafting (CABG) surgery with open heart technique on respiratory functions, functional capacity, and quality of life (QoL). Design. This randomised controlled study applied the Consolidated Standards of Reporting Trials statement. Methods. The study was conducted with two groups: the intervention group ( n = 25 ) and the control group ( n = 25 ). The control group received standard care after coronary artery bypass grafting. On the contrary, the experimental group participated in a PR program created by the researchers in addition to standard care. After coronary artery bypass grafting, the respiratory functions (on the 4th day of clinical care) and QoL (at the 6th week) of both groups were evaluated. The primary outcome measure was the respiratory function (forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC). The secondary outcome measure of this study was the QoL. Results. When the average pulmonary function test values of the patients were examined, the mean FVC and FEV1 values of the patients in the intervention group on the 4th day of clinical care were significantly higher with a medium level size effect than the control group ( p = 0.027 ; effect size d = 0.643 ; p < 0.024 ; effect size d = 0.658 , respectively). At the postoperative 6th week measurement of QoL, a decrease was observed in all subdimensions of the scale, albeit less in the intervention group ( p < 0.05 ). There was a decrease in both the mental and physical component summary of QoL ( p < 0.05 ). Conclusion. The results of this study revealed that pulmonary rehabilitation applied to patients who have undergone coronary artery bypass graft recover their functional capacity faster.

OBJECTIVES: Task-specific movement training is a proposed intervention for patellofemoral pain aimed to optimise movement during daily tasks. Focused, progressive task practice emphasising optimal limb alignment may yield improvements in performance-based function and hip muscle strength, and transfer learnt movement patterns to untrained tasks. The purpose of this study was to determine if task-specific movement training improves performance-based function (composite score, movement, pain during movement) in an untrained task. Our secondary purpose was to test whether hip muscle strength improved following the movement training intervention. METHODS: This study was a secondary analysis of a prospective, non-randomised, within-group, double-baseline study. Twenty-three females with patellofemoral pain underwent task-specific movement training two times/week for 6 weeks. Outcomes were collected at three time points: enrolment (baseline), 6 weeks (preintervention) and 12 weeks (postintervention). A repeated measures analysis of variance tested whether the change during the intervention phase was greater than the change during the control phase. Y-balance composite score, hip and knee kinematics and pain during the Y-balance test were primary outcome measures; strength of the hip lateral rotator, abductor and extensor muscles was a secondary outcome measure. RESULTS: The change in composite score for the Y-balance test was not statistically significantly different between the intervention and control phases (p=0.16). The change during the intervention phase exceeded the change during the control phase for hip and knee kinematics and pain during the Y-balance test, with all variables improving (p

The current pandemic of COVID-19 warrants a repeal from conventional dentistry to an aerosol free, minimally invasive yet maximally effective clinical approach. Silver diamine fluoride (SDF) is an established modality for caries arrest in children fulfilling all the above. This extensive 25 case series highlights various clinical situations in which SDF was successfully used in children between 1-12 years of age with asymptomatic carious lesions of ICDAS score 2 or more in primary and permanent teeth. Primary outcome measure was caries arrest in the form of the hard and shiny lesion with no/minimal sensitivity. The secondary outcome measure was the zombie effect which was the residual staining on other tooth surfaces and indications of substantivity. SDF can be effectively and efficaciously used across different behaviour patterns and age groups of children in a various clinical scenario for both primary and permanent teeth routinely experienced in a paediatric dental office especially during these pandemic times with minimal aerosol generation.

Introduction/aims Perampanel, a selective noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) antagonist, is capable of slowing the progression of the amyotrophic lateral sclerosis (ALS) phenotype and increasing the number of anterior horn cells in transgenic mice. Trials of perampanel in epilepsy showed a favorable tolerability profile. In this study we aimed to determine the tolerability and safety of perampanel in patients with ALS. Methods Enrolled subjects were started on 2 mg/day of perampanel and the dose was increased by 2 mg/day every week to a maximum dose of 8 mg/day. Our primary outcome measure was tolerability, which was evaluated by monitoring adverse events. The secondary outcome measure was clinical progression, assessed using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and spirometry. Results Six participants were enrolled. All had adverse events, mostly behavioral. Two completed the trial and the other four withdrew due to adverse events. All participants reported resolution of these events after discontinuation of the drug. The trial was halted due to the large number of adverse events. Discussion The use of perampanel in this study of ALS was limited by its poor tolerability.

Background Traumatic brain injury (TBI) is the leading cause of death and disability in children, but effective tools for predicting outcome remain elusive. Although many pediatric patients receive early magnetic resonance imaging (MRI), data on its utility in prognostication are lacking. Diffuse axonal injury (DAI) is a hallmark of TBI detected on early MRI and was shown previously to improve prognostication in adult patients with TBI. In this exploratory study, we investigated whether DAI grade correlates with functional outcome and improves prognostic accuracy when combined with core clinical variables and computed tomography (CT) biomarkers in pediatric patients with moderate-severe TBI (msTBI). Methods Pediatric patients (≤ 19 years) who were admitted to two regional level one trauma centers with a diagnosis of msTBI (Glasgow Coma Scale [GCS] score

Background Universal screening is a strategy for addressing the limitations of risk-based screening for gonorrhea and chlamydia (GC/CT). This quality improvement (QI) initiative aimed to improve GC/CT screening by implementing universal annual screening for all adolescents ≥ 13 years old. Methods At an academic pediatric resident continuity clinic, an interdisciplinary team designed and conducted multiple Plan-Do-Study-Act (PDSA) cycles over one year. The primary aim, and process measure, was to increase the percentage of encounters with screening for GC/CT in the 12 months prior to the encounter to 80%. The secondary outcome measure was rate of detection of GC or CT infection. Further, pulse checks of provider/staff knowledge and adherence were conducted. The balancing measure was denied insurance claims. Results The mean screening rate of 29.2% increased during the project implementation to 65.1% with several bundles of PDSA cycles. There were no cases of gonorrhea detected in the baseline period or implementation period. The case rate of chlamydia was similar during both periods (from 9.7 per 1,000 adolescent encounters to 10.8 per 1,000 adolescent encounters, p = 0.74). There was similarly high provider/staff knowledge about (p = 0.35) and adherence to (p = 0.06) the screening protocol at 6 and 12 months of implementation. There was no increase in percentage of denied insurance claims. Conclusion This QI initiative doubled rates of GC/CT screening with no statistically significant increase in number of cases.

As one of the initial ten sites in Ohio designated to receive and distribute the first COVID‐19 vaccines in December 2020, we initiated a self‐reported IRB‐approved research survey to describe the demographics, side‐effects, and missed work time experienced by front‐line health care workers in an urban tertiary care center and a rural regional hospital. First responders from both the urban and rural surrounding communities were also included in the initial Tier 1A vaccine distribution. The primary outcome measure was to identify the most frequently experienced side effects from the Pfizer and Moderna vaccines, based on type of vaccine, first or second dose, age, gender, race and occupation. The secondary outcome measure was to document the total number of work shifts missed after receiving the vaccine. Of interest to health care risk managers, the survey identified the most common side effects and resulting missed time from work broken down by type of vaccine and first or second dose. This information will be helpful for those institutions who have not yet vaccinated a majority of their work force, employees who still need their second dose, and for strategic scheduling of employees when booster doses become available later in the year.

Purpose: The aim of this study was to determine the effectiveness of two different lung ultrasonography (LUS) methods that can be used in the diagnosis of coronavirus disease 2019 (COVID-19) and to investigate their correlations with computed tomography (CT).Methods: In this prospective, randomized, and single-blind study, 60 patients with COVID-19 were included. The patients were randomized to either the 12-zone LUS group (n=30) or the 14-zone LUS group (n=30). The correlation between LUS and thoracic CT scores was evaluated. As a secondary outcome measure, the characteristic features of the findings of thoracic CT and LUS were examined.Results: The study was completed with a total of 59 patients. Moderate and high correlations were found between the total CT and LUS scores in the 12-zone and 14-zone study groups. There were no statistically significant differences in the lesion types detected in patients using LUS and CT (P>0.05). The left lung lower lobe CT scores were statistically significantly lower in the 14-zone study group than in the 12-zone group (P=0.019). The left lower lobe CT and LUS scores were highly correlated in the 14-zone group (P

Background Bladder dysfunction is the most common autonomic disturbance in people with MS (PwMS). Only a few studies have examined the relationship between bladder dysfunction and falls in PwMS. Bladder dysfunction has been deemed only a secondary outcome measure, and classified by a gross measure providing a limited perspective of this disturbing symptom. Furthermore, no study to date has focused on the relationship between bladder dysfunction and balance performance in PwMS. Research question Determine the relationship between bladder dysfunction with balance, falls and fear of falling in women with MS. Methods The study was observational, including 44 women with MS, mean age 46.3 (SD = 5.7), all with at least a mild bladder dysfunction. Outcome measures included the Urinary Incontinence Quality of Life Scale (I-QoL), Bladder Control Scale (BLCS), Timed Up and Go Test (TUG), Four Square Step Test (FSST), Falls Efficacy Scale International (FES-I), Falls status, and posturography. Results Participants performed the TUG in 14.1 s (S.D. = 11.1), and the FSST in 20.5 s (S.D. = 22.4). A relatively large proportion (68.2 %) of women was classified as fallers. However, no differences were found between those classified as fallers (n = 30) or non-fallers (n = 14) in terms of the I-QoL and the BLCS, controlling for age, EDSS and number of vaginal deliveries. Significant correlations scores were found between the I-QoL, BLCS and FES-I (rho ∼0.47), while controlling for age, EDSS and number of vaginal deliveries. No associations were demonstrated between the bladder dysfunction outcome scores and either the TUG and/or FSST. Significance Women afflicted with MS and suffering from bladder dysfunction tend to fall and present with more balance difficulties compared with disability-matched PwMS. Nevertheless, once bladder dysfunction is detected, the perceived severity of the condition is not associated with balance and prevalence of falling, but rather on fear of falling.

Purpose To explore caries predictors at age 1 year and caries development at ages 5 and 7 years in two groups of children following different fluoride-based preventive programs. Methods We conducted a prospective cluster-randomized controlled intervention trial with two parallel arms comparing two prevention programs: one program included fluoride varnish applications every 6 months, the other did not; otherwise, the programs were the same. Participants were 1- and 3-year-old children enrolled at 23 dental clinics in high-risk areas in Stockholm, Sweden. The baseline examination included structured interviews. Caries data were extracted from dental records. The primary outcome measures were ICDAS 1–6 > 0 at baseline (age 1 year) and defs > 0 at ages 2, 3, 5, and 7 years. The secondary outcome measure at age 7 was DFS > 0. Results Continuous caries development occurred: defs > 0 in 23% at 5 years and in 42% at 7 years. We found no difference in caries development between children who had or had not received fluoride varnish as toddlers. At age 1-year, significant predictors for dental caries in later preschool years were immigrant background, family income, and sweets consumption. Fluoride toothpaste > once a day at 1 year had an OR 0 at 5- and 7 years. Conclusions For toddlers, fluoride varnish does not seem to be an adequate prevention tool. Brushing with fluoride toothpaste from 1 year of age could not arrest caries development. Immigrant background was the strongest predictor. A new toolbox as well as collaborative upstream actions for reducing free-sugar intake are needed.

PURPOSE: To assess whether the GnRH-agonist or urinary-hCG ovulation triggers affect oocyte competence in a setting entailing vitrified-warmed euploid blastocyst transfer. METHODS: Observational study (April 2013–July 2018) including 2104 patients (1015 and 1089 in the GnRH-a and u-hCG group, respectively) collecting ≥1 cumulus-oocyte-complex (COC) and undergoing ICSI with ejaculated sperm, blastocyst culture, trophectoderm biopsy, comprehensive-chromosome-testing, and vitrified-warmed transfers at a private clinic. The primary outcome measure was the euploid-blastocyst-rate per inseminated oocytes. The secondary outcome measure was the maturation-rate per COCs. Also, the live-birth-rate (LBR) per transfer and the cumulative-live-birth-delivery-rate (CLBdR) among completed cycles were investigated. All data were adjusted for confounders. RESULTS: The generalized-linear-model adjusted for maternal age highlighted no difference in the mean euploid-blastocyst-rate per inseminated oocytes in either group. The LBR per transfer was similar: 44% (n=403/915) and 46% (n=280/608) in GnRH-a and hCG, respectively. On the other hand, a difference was reported regarding the CLBdR per oocyte retrieval among completed cycles, with 42% (n=374/898) and 25% (n=258/1034) in the GnRh-a and u-hCG groups, respectively. Nevertheless, this variance was due to a lower maternal age and higher number of inseminated oocytes in the GnRH-a group, and not imputable to the ovulation trigger itself (multivariate-OR=1.3, 95%CI: 0.9–1.6, adjusted p-value=0.1). CONCLUSION: GnRH-a trigger is a valid alternative to u-hCG in freeze-all cycles, not only for patients at high risk for OHSS. Such strategy might increase the safety and flexibility of controlled-ovarian-stimulation with no impact on oocyte competence and IVF efficacy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10815-021-02124-1.

The emergence of Covid-19 has caused a pandemic and is a major public health concern. Covid-19 has fundamentally challenged the global health care system in all aspects. However, there is a growing concern for the subsequent detrimental effects of continuing delays or adjustments on time-dependent treatments for Covid-19 negative patients. Patients arriving to the ED with STEMIs and acute CVA are currently presumed to have delays due to Covid-19 related concerns. The objective of this paper is to evaluate the implications of the Covid-19 pandemic on non-Covid19 patients in emergency care settings. We conducted a retrospective study from February 2020 to April 2020 and compared this to a parallel period in 2019 to assess the impact of the Covid-19 pandemic on three distinct non-Covid-19 ED diagnosis that require immediate intervention. Our primary outcome measures were time to primary PCI in acute STEMI, time to fibrinolysis in acute CVA, and time to femoral hip fracture correction surgery. Our secondary outcome measure included a composite outcome of length of stay in hospital and mortality. From 1 February 2020 to 30 April 2020, the total referrals to ED diagnosed with STEMI, Hip fracture and CVA of which required intervention were 197 within Covid-19 group 2020 compared to 250 in the control group 2019. Mean duration to intervention (PCI, surgery and tPA, respectively) did not differ between COVID-19 group and 2019 group. Among femoral hip fracture patients', the referral numbers to ED were significantly lower in Covid-19 era (p = 0.040) and the hospitalization stay was significantly shorter (p = 0.003). Among CVA patients', we found statistical differences among the number of referrals and the patients' age. Coping with the Covid-19 pandemic presents a challenge for the general healthcare system. Our results suggest that with proper management, despite the obstacles of isolation policies and social distancing, any negative impact on the quality of health care for the non-Covid-19 patients can be minimized in the emergency department setting.

Introduction The postoperative seizure freedom represents an important secondary outcome measure in glioblastoma surgery. Recently, supra-total glioblastoma resection in terms of anterior temporal lobectomy (ATL) has gained growing attention with regard to superior long-term disease control for temporal-located glioblastoma compared to conventional gross-total resections (GTR). However, the impact of ATL on seizure outcome in these patients is unknown. We therefore analyzed ATL and GTR as differing extents of resection in regard of postoperative seizure control in patients with temporal glioblastoma and preoperative symptomatic seizures. Methods Between 2012 and 2018, 33 patients with preoperative seizures underwent GTR or ATL for temporal glioblastoma at the authors’ institution. Seizure outcome was assessed postoperatively and 6 months after tumor resection according to the International League Against Epilepsy (ILAE) classification and stratified into favorable (ILAE class 1) versus unfavorable (ILAE class 2–6). Results Overall, 23 out of 33 patients (70%) with preoperative seizures achieved favorable seizure outcome following resection of temporal located glioblastoma. For the ATL group, postoperative seizure freedom was present in 13 out of 13 patients (100%). In comparison, respective rates for the GTR group were 10 out of 20 patients (50%) (p = 0.002; OR 27; 95% CI 1.4–515.9). Conclusions ATL in terms of a supra-total resection strategy was associated with superior favorable seizure outcome following temporal glioblastoma resection compared to GTR. Regarding above mentioned survival benefit following ATL compared to GTR, ATL as an aggressive supra-total resection regime might constitute the surgical modality of choice for temporal-located glioblastoma.

Purpose To study the outcomes of cultivated oral mucosal epithelial transplantation (COMET) in eyes with chronic Stevens-Johnson syndrome (SJS) sequelae. Design Prospective interventional case series. Methods Forty-five eyes of 41 patients with chronic SJS sequelae were recruited and evaluated from 2013 to 2017 in an institutional setting. All patients underwent COMET, with an aim of fornix reconstruction and visual rehabilitation. Change in corrected distance visual acuity (CDVA), severity scores of various ocular surface parameters, and the occurrence of complications were documented during a follow up period of 2 years. Attainment and maintenance of a stable ocular surface, as assessed by change in the ocular surface severity scores was the primary outcome measure, while change in CDVA was the secondary outcome measure. Results The mean preoperative CDVA was 2.7± 0.5 logMAR, which improved to 1.5± 0.7 logMAR and 1.49± 0.98 postoperatively, at 1- and 2-year follow-up visit. Overall, 82.2% eyes (37/45) had improvement in visual acuity, 13.3% (6/45) experienced no change, whereas 2 eyes (4.4%) had worsening of visual acuity. The total ocular surface severity scores improved from a mean preoperative value of 29.1± 9.7 to 18.7± 7.2 postoperatively, at 2-year follow-up. Two eyes developed persistent epithelial defects, with progression to corneal melting requiring keratoplasty. Conclusions COMET allows successful and sustained restoration of ocular surface anatomy with functional improvement, in eyes with chronic sequelae of SJS.

Although numerous studies have demonstrated that concomitant low back pain (LBP) is associated with worse functional outcomes in patients undergoing total hip and knee arthroplasty, no study has analyzed its impact on patients undergoing total ankle arthroplasty (TAA). The aim of this study was to determine the prevalence of LBP in people undergoing TAA and analyze its impact on patient reported functional outcome measures (PROMs). A retrospective review was performed on data from the Vancouver End Stage Ankle Arthritis Database. In total, 87 patients undergoing TAA were studied, with patient demographics collected preoperatively, including the absence or presence of LBP. Postoperative follow-up was performed at 5 years, primarily analyzing disease-specific PROMs including the Ankle Osteoarthritis Score and Ankle Arthritis Score. The Short Form-36 was used as a secondary outcome measure to assess global function. Multivariable linear mixed-effects regression models were conducted to compare the PROM between patients with LBP with those without LBP. In total, 30 patients (35%) presented with concomitant LBP. There were no significant differences at baseline between the LBP group and no LBP group in terms of demographics or baseline primary disease-specific PROMs. At 5 years, the patients with LBP had significantly worse Ankle Arthritis Score (32 ± 23 vs 22 ± 17, p = .03), Ankle Osteoarthritis Score Total (34 ± 23 vs 22 ± 16, p = .01), and Short Form-36 physical (PCS) components summaries (33 ± 12 vs 44 ± 9, p = .001) compared to the no-LBP group. Both groups improved significantly from baseline across all outcome measures. Our study demonstrated that the prevalence of concomitant LBP in end stage ankle arthritis undergoing TAA is similar to that described in arthritic knees and hips. If present, it can be associated with worse functional outcomes in the intermediate term. However it is not a contraindication to surgery, with patients still experiencing significant improvements from baseline. Further studies are needed to evaluate if LBP influences complications, implant failure rates and survival.

Background Varying results after surgery in patients with subacromial pain syndrome (SAPS) have raised the question on whether there is a subgroup of patients that can benefit from surgery. Therefore, we aimed to identify preoperative and peroperative factors associated with a favorable patient-reported outcome after arthroscopic bursectomy in patients with SAPS. Methods Patients with chronic SAPS who underwent arthroscopic bursectomy after failed conservative management were included (n = 94). Patients were evaluated at the baseline, and 2 weeks, 8 weeks, 6 months, and 1 year after surgery. The primary outcome was the Western Ontario Rotator Cuff index (WORC) score one year after surgery. The secondary outcome measure was a visual analog scale for pain. Mixed model analyses were used to identify prognostic factors. Results The mean WORC (mean difference 39%, 95% confidence interval (CI) 32.8–45.3, P < .001) and visual analog scale pain scores (mean difference 41 mm points, 95% CI 3.37–4.88, P < .001) significantly improved one year after surgery. Nineteen patients (20%) developed a postoperative frozen shoulder. A longer duration of preoperative complaints and the peroperative identification of degenerative glenoid cartilage were associated with significantly worse WORC scores, with −0.086% per month (95% CI −0.156 to −0.016, P = .016) and −20% (95% CI −39.4 to −1.26, P = .037), respectively. Conclusion We identified demographic and clinical factors that predict the course after arthroscopic subacromial bursectomy. We found that arthroscopic bursectomy is less effective in patients with SAPS with a degenerative shoulder. This finding suggests that an improved treatment effect of arthroscopic subacromial bursectomy can be expected in patients with chronic SAPS if intra-articular pathologies such as glenohumeral osteoarthritis are sufficiently excluded.

Both from the perspective of the individual and from a socioeconomic point of view (e.g., return to work), it is important to have an insight into the potential differences in recovery between posterior cruciate ligament retaining (PCR) and posterior stabilized (PS) total knee arthroplasty (TKA) implants. The primary aim of this study was to compare the speed of recovery of patient-reported outcome between patients with a PCR and PS TKA during the first postoperative year. The secondary aim was to compare the effect on range of motion (ROM). In a randomized, double-blind, controlled, single-center trial, 120 adults diagnosed with osteoarthritis of the knee were randomized into either the PCR or PS group. Primary outcome was speed of recovery of patient-reported pain and function, measured with the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), with a follow-up of 1 year. Main secondary outcome measure was ROM. A generalized estimating equations (GEE) analysis was used to assess whether there was a difference over time between groups (“p-value for interaction”). Between 2008 and 2011, 59 participants received a PCR TKA (mean age, 70.3 years [SD = 7.7]; mean body mass index [BMI], 30.5 kg/m2 [SD = 5.4]) and 55 participants a PS TKA (mean age, 73.5 years [SD = 7.0]; mean BMI, 29.2 kg/m2 [SD = 4.4]). Six patients (two PCR and four PS) were excluded because of early drop-out, so 114 patients (95%) were available for analysis. In between group difference for total WOMAC score was −1.3 (95% confidence interval [CI]: −5.6 to 3.1); p-value for interaction was 0.698. For ROM, in between group difference was 1.1 (95% CI: −2.6 to 4.7); p-value for interaction was 0.379. These results demonstrated that there are no differences in speed of recovery of WOMAC or ROM during the first postoperative year after PCR or PS TKA.

Introduction: Although intra-operative neuromonitoring (IONM) has become commonly used to identify the recurrent laryngeal nerve (RLN) during thyroid surgeries, its value is still debatable. This study aimed to evaluate the outcomes of thyroid surgery using IONM versus visualisation alone (VA). Methods: We conducted a retrospective analysis of all the open thyroidectomies performed by the otolaryngology department in a tertiary institution in Singapore (Khoo Teck Puat Hospital) from 1 January 2014 to 31 December 2018. There were 301 nerves-at-risk (NAR), 139 in the IONM group and 162 in the VA group. The primary outcome measure was the incidence of RLN injury and the secondary outcome measure was operative duration. Results: There were 33 NAR with immediate post-operative RLN injury, of which 7 had permanent (>6 months) injury. There were minor improvements in the respective rates of immediate and permanent injury in the IONM group (7.9%, 0.7%) compared to the VA group (13.6%, 3.8%), but these were not statistically significant (P=0.14, 0.13). The average operative duration of total thyroidectomies in the IONM group was 37 minutes shorter than in the VA group, but the difference was not statistically significant (P=0.40). Conclusion: The current study shows that the use of intra-operative neuromonitoring shows a tendency towards better RLN outcome and operative duration for total thyroidectomies, but the study may be too small to demonstrate a statistical difference. Keywords: Nerve monitoring, otorhinolaryngology, surgery, thyroid, vocal cord paralysis

Background: Bishop Score is still the usual method to expect the results of labor induction. Transvaginal ultrasonographic measurement of cervical length (TVUS-CL) is more objective and insulin like growth factor binding protein-1(IGFBP-1) has been recently used for this aim. Objective: This study was conducted to compare between TVUS-CL and detection of cervical (IGFBP-1) for prediction of results of induction of labor after 37 week of pregnancy. Patients and Methods: A prospective cohort study on 140 pregnant women underwent induction of labor. All patients were subjected to TVUS-CL and detection of cervical (IGFBP-1) and Bishop Score. The primary outcome measure was induction success. The secondary outcome measure was induction to delivery interval. Results: In our study (97) females delivered by simple vaginal delivery (SVD), (79) females delivered within 24 hour of induction, (18) females delivered after 24 hour, and (43) females delivered by caesarian section. The mean cervical length measured by TVUS in females who delivered by SVD was 24.89 ±5.48 mm and was 26.79±3.06 mm in those who delivered by CS. IGFBP-1 was positive in 71 females who delivered by SVD and in 17 females who delivered by CS and it was negative in 26 females who delivered by SVD and 26 females who delivered by CS. Conclusion: Success of labor induction correlated significantly with detection of cervical IGFBP-1 and measurement of cervical length by TVUS.

Background Up to 50% of people with amyotrophic lateral sclerosis (ALS) experience cognitive dysfunction, whilst depression and anxiety are reported in up to 44% and 33%, respectively. These symptoms impact on quality of life, and are associated with a poorer prognosis. Historically, outcomes in clinical trials have focused on the effect of candidate drugs on physical functioning. Methods We reviewed the past 25 years of clinical trials of investigative medicinal products in people with ALS, since the licensing of riluzole, and extracted data on frequency and type of assessment for neuropsychiatric symptoms and cognitive impairment. Trial registry databases, including WHO International Trials Registry, European Clinical Trials Register, clinicaltrials.gov, and PubMed, were systematically searched for Phase II, III or IV trials registered, completed or published between 01/01/1994 and 31/10/2019. No language restrictions were applied. Outcome measures, exclusion criteria and assessment tool used were extracted. Results 216 trials, investigating 26,326 people with ALS, were reviewed. 35% assessed neuropsychiatric symptoms, and 22% assessed cognition, as Exclusion Criteria or Outcome Measures. 3% (n = 6) of trials assessed neuropsychiatric symptoms as a Secondary Outcome Measure, and 4% (n = 8) assessed cognition as Outcome Measures; only one trial included assessments for both cognition and neuropsychiatric symptoms as Outcome Measures. Three ALS-specific assessments were used in six trials. Conclusions Trials for people with ALS have neglected the importance of neuropsychiatric symptoms and cognitive impairment. Evaluation of these extra-motor features is essential to understanding the impact of candidate drugs on all symptoms of ALS. PROPSERO registration CRD42020175612.

Background and objectives Sarcopenia is an objective measure of patient frailty and is a predictor of adverse surgical outcomes. We hypothesized that sarcopenia is associated with increased surgical site occurrence (SSO) and hernia occurrences in patients undergoing oncologic abdominal wall reconstruction. Methods Consecutive patients who underwent abdominal wall reconstruction (AWR) for an abdominal wall ablative defect at a single center from 2005 to 2015 were evaluated. The total psoas index (TPI) was used to define sarcopenia. The primary endpoint of the study was hernia occurrence; (SSO) was a secondary outcome measure. Results Eighty-six patients met the inclusion criteria. Multivariate analysis demonstrated that sarcopenia increased the risk of hernia more than threefold, trending toward significance (OR = 3.3; 95% CI: 0.69-15.4; P = .13). Multivariate logistic regression demonstrated that preoperative radiotherapy (OR = 4.8, 95% CI: 1.4-16; P = .01) and obesity (OR = 4.9, 95% CI: 1.5-16.3; P =.009) were independent predictors of developing an SSO. Conclusions Sarcopenia, as defined by TPI, is correlated with hernia occurrence, but not SSO. These findings emphasize the importance of preoperative fitness and nutritional optimization and provide useful information for preoperative counseling and risk stratification.

Background Adolescent idiopathic scoliosis (AIS) is the most common form of spinal deformity in children and adolescents which presents as complex three-dimensional (3D) deformity of the spine and rib cage. This study aimed to estimate the effectiveness and safety of surgical interventions for AIS using Bayesian meta-analysis. Methods The PubMed, EMBASE, and Cochrane Controlled Register of Trials were searched through Oct 1, 2019, without language restrictions. Relevant studies evaluating combined effectiveness and safety of surgical interventions for AIS were included according to eligibility criteria. The primary outcome measures included pulmonary function (change of absolute forced vital capacity and forced expiratory volume in 1 second from pre-operation to post-operation) and incidence of complications. The secondary outcome measure was change of Cobb angle from pre-operation to post-operation. Data was pooled using a random effects model in pairwise meta-analysis. Bayesian meta-analysis combined direct and indirect evidence using a Bayesian framework. Results Twenty-eight case-controlled studies with totally 1970 participants were included. This Bayesian meta-analysis combining direct and indirect evidences indicated that posterior fusion with instrumentation without thoracoplasty (PSF) had the highest probability to achieve better pulmonary function and lower complication rate; video assisted anterior fusion with instrumentation without thoracoplasty (VAT) had the highest probability to obtain better Cobb angle correction based on analysis of rank probability. Conclusion This Bayesian meta-analysis demonstrated that PSF had the highest probability to achieve better post-surgical pulmonary function and lower complication rate, which gives a practical recommendation of PSF as a primary surgical treatment for AIS. The results also support statistics that current surgeries adopted more PSF but less open anterior approach surgery and thoracoplasty. More research work is required to address the effectiveness and safety of VAT for treating AIS more convincingly.

PURPOSE: To investigate the effectiveness of outpatient robot -assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.METHODS: Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure -88 (GMFM E) as the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5 -week follow-up.RESULTS: The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were - 0.7 (- 2.8 to 3.5) after RAGT and 0 (- 2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow-up, or carry-over effects observable.CONCLUSIONS: RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children?s personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.

Background Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence. Methods A systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality. Results Twelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool. Conclusion The evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.

Stand-alone zero-profile devices have already proven safety, and a reduced dysphagia rate was assumed. So far, no level-one evidence is available to prove the proposed advantages of zero-profile implants in multilevel procedures. The aim of this RCT was to compare the clinical and radiological outcome of a zero-profile spacer versus cage + plate in two-level ACDF. Consecutive patients with contiguous two-level cDD were randomly assigned either to the interventional group (zero-profile device) or to the control group (cage + plate). Primary endpoint of the study was the prevalence of dysphagia at 24 months. Disability, progress of adjacent segment degeneration, fusion status and loss of correction were analyzed as secondary outcome measure. Primary outcome parameter was statistically analyzed by Chi-square test. Forty-one patients met inclusion criteria and were randomly assigned to the interventional and the control group. Dysphagia was frequent in either group at 3 months FU favoring interventional group (p = 0.078). At final FU, less patients of the interventional group complained about dysphagia, but the difference was not significant. No relevant differences at final FU were recorded for NPDI, loss of correction and adjacent-level degeneration. Fusion rate was slightly lower in the interventional group. Two-level ACDF either by a stand-alone zero-profile spacer or cage + plate is safe. Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate. Hence, this randomized trial was not able to prove the proposed clinical superiority for dysphagia rates for zero-profile anchored spacer in two-level cDD.

White matter hyperintensities (WMHs) are a risk factor for cognitive decline. Physical activity (PA) is associated with lower WMH. Whether long-term exposure to PA programs has beneficial effects on WMH progression in older adults with memory complaints and comorbid conditions has had limited exploration. This study explored whether a 24-month moderate-intensity PA intervention can delay the progression of WMH and hippocampus loss in older adults at risk for cognitive decline. Data acquired on magnetic resonance imaging were used to measure the progression of WMH and hippocampus loss. The results of this study showed no effect of intervention on either the primary outcome measure "WMH" or the secondary outcome measure "hippocampal volume." In addition, neither beta amyloid status nor the adherence to the intervention had any effect on the outcome. In this cohort of subjective memory complaints and mild cognitive impairment participants with vascular risk factors, there was no effect of long-term moderate-intensity PA on WMH or hippocampal loss.

The number of Revision TKAs performed continues to increase; however there is limited data on risk factors for failure. Additionally, clinical decisions regarding when and how to revise a failed TKA may be as important as the technical aspects of the procedure. The purpose of this study was to analyze factors predicting repeat revision following aseptic revision TKA. Of 85,769 primary TKAs recorded on the New Zealand National Joint Registry, 1720 patients undergoing subsequent revision for aseptic indications between January 1999 and December 2015 were identified. Re-revision was recorded in 208 patients (12.1%). The analysis included demographic characteristics, surgeon revision case volume, surgical time, surgical ownership of index TKA as independent variables using logistic and linear regression. The primary outcome measure was incidence of subsequent re-revision and Oxford Knee Scores of revised TKAs (OKS). The secondary outcome measure was the influence of component exchange in major revisions on re-revision rate. Younger patients undergoing a revision (HR 0.974) and male gender (HR 0.666) were predictors of re-revision. Elapsed time since index surgery (unstandardized coefficient 0.060) and lower ASA score (UC − 2.749) were significant predictors of OKS. Femoral component revision was a predictor of re-revision (HR 1.696) and had the lowest OKS, compared to tibial and all component revision (p = 0.003). Repeat revision TKA is a rare and complex procedure influenced by a number of confounding factors. Using raw registry data, younger and male patients were found to be at a higher risk of re-revision after aseptic revision TKA. A longer time between primary TKA and revision was associated with better clinical outcomes. Isolated femoral component exchange led to worse outcomes both in terms of survivorship and functional scores. III.

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) have shown different weight loss results. These differences might be partly due to dumping after LRYGB, forcing sweet eaters to switch to a healthy diet. The Dutch Sweet Eating Questionnaire (DSEQ) is validated to measure sweet eating. This study aims to investigate if sweet eating measured with the DSEQ influences weight loss. In this multicenter randomized controlled trial, patients were included between 2013 and 2017 in two Dutch high-volume hospitals, and randomized with a 1:1 ratio between LRYGB and LSG. Primary outcome measure was weight loss. Secondary outcome measure was sweet eating behavior, measured with the DSEQ. Data was collected at baseline, 1 year and 2 years postoperatively. Data was analyzed of 623 patients who underwent LRYGB (n = 308; 49.4%) or LSG (n = 315; 50.6%). Follow-up rates at 2 years postoperative were 67.1% for weight and 35.3% for DSEQ. At 2 years postoperative, mean BMI was significantly higher after LSG than LRYGB (respectively 30.88 versus 28.87 kg/m2, p

Objective Lateral humeral condyle fractures are the second most common elbow fractures in children. Both K-wire fixation and screw fixation have been advocated as suitable treatment options for displaced fractures. This study aimed to identify which fixation method was associated with the best functional outcomes. Methods A systematic review was conducted. Studies reporting functional outcomes following surgical fixation of lateral condyle fractures were included for review. The primary outcome measure was functional outcome. The secondary outcome measure was major complications. A narrative analysis was undertaken, as meta-analysis was felt to be inappropriate due to the differences between included studies. Results Ten retrospective non-randomised, comparative studies were eligible and included. No randomised-controlled trials were identified. The highest rate of excellent functional outcomes was seen with screw fixation (120/126 [95%]), compared with K-wire fixation (135/162 [86%]). The incidence of major complications was comparable, with complications in 6/95 (6%) of screw fixations and 6/141 (4%) K-wire fixations. A small sample of data on closed reduction demonstrated excellent functional results in 73 of 76 (96%) of patients. Closed reduction of displaced fractures is associated with a significant learning curve however. Conclusion The evidence was of poor quality and comprised of retrospective case series. This prevented meta-analysis and any firm conclusions being drawn from the available data. Screw fixation may be associated with improved functional outcomes. Complication rates between the two methods are comparable. Further prospective studies are recommended.

Aim Accurate preoperative identification of perianal fistula tracts and internal openings can facilitate the choice of surgical procedure and may lead to improved healing rates. Our aim was to explore the effectiveness of three-dimensional endoanal ultrasound (3D-EAUS) in determining the type of perianal fistula and planning operative management. Method This was a cohort longitudinal study. Patients with perianal fistulas from January 2017 to January 2018 who underwent 3D-EAUS and subsequent surgery were included. Intra-operative findings were considered as standard for comparison with clinical examination and 3D-EAUS findings. The primary outcome measure was to evaluate the concordance between 3D-EAUS and intra-operative findings and the secondary outcome measure was healing rates. Results Sixty-eight patients with a mean age of 43.1 ± 14.1 years were included. Twenty-eight patients had inter-sphincteric (41.2%) and 40 (14 high and 26 low) trans-sphincteric fistulas (58.8%). 3D-EAUS, clinical examination and intra-operative exploration could predict the location of internal openings in 62/68 (91.2%), 48/68 (70.5%) and 56/68 (82.4%) patients, respectively. Hydrogen peroxide (H₂O₂)-enhanced 3D-EAUS accurately predicted the location of internal openings when compared with 3D-EAUS without H₂O₂ (concordance K = 0.963, P = 0.05). High concordance rates were seen between intra-operative and 3D-EAUS findings on the type of perianal fistula. No significant difference was seen between the suggested surgical treatment based on 3D-EAUS and the eventual surgical treatment (P > 0.05). Study limitations were the small sample size and lack of randomization. Conclusion 3D-EAUS may be considered as a first-line investigation for patients with perianal fistulas because of high concordance with intra-operative assessment and facilitation of surgical planning.

Background Bilateral priming, device assisted bilateral symmetrical wrist flexion/extension, is a noninvasive neuromodulation technique that can be used in the clinic. Objective We examined the additive effect of bilateral motor priming and task specific training in individuals with severe upper limb hemiparesis. Methods This is a parallel assignment, single-masked, randomized exploratory pilot study with three timepoints (pre-/post-intervention and follow up). Participants received either bilateral motor priming or health care education followed by task specific training. Sixteen participants who were at least 6 months post-stroke and had a Fugl Meyer Upper Extremity (FMUE) score between 23 and 38 were randomized. Our primary and secondary measures were Chedoke Arm & Hand Activity Index 9 (CAHAI-9) and the FMUE respectively. We determined changes in interhemispheric inhibition using transcranial magnetic stimulation. We hypothesized that improvement in the priming group would persist at follow up. Results There was no between-group difference in the CAHAI. The improvement in the FMUE was significantly greater in the experimental group at follow up (t = 2.241, p = 0.045). Conclusions Both groups improved in the CAHAI. There was a significant between-group difference in the secondary outcome measure (FMUE) where the bilateral priming group had an average increase of 10 points from pre-intervention to follow up.

Pelvic floor muscle training (PFMT) and lifestyle advice are effective at improving the symptoms and severity of pelvic organ prolapse (POP) in a range of populations; however, the impact of these interventions in Nepali women is unknown. We aimed to evaluate the impact of an informational flipchart on PFMT and lifestyle advice on the quality of life (QOL) for Nepali women with a POP. This prospective randomized controlled trial recruited 140 women with a stage I–III POP from Kathmandu Valley. The intervention group were instructed on PFMT and lifestyle advice through an informational flipchart and the control group were provided usual care. The primary outcome measure was the Prolapse Quality of Life questionnaire (P-QOL) and was completed at baseline, 6 weeks, 12 weeks and 6 months. The secondary outcome measure was the Pelvic Organ Prolapse Quantification (POP-Q) system and Modified Oxford Scale (MOS) assessed by clinical examination at baseline and 6 months. Differences in mean P-QOL scores for each domain were evaluated using analysis of covariance. Compared with usual care, the women in the informational flipchart group experienced significant improvement in six of the nine P-QOL domains and for the prolapse, bladder and bowel symptoms. Only a small percentage (20%) of women were able to attend the 6-month clinical assessment so we were unable to assess the secondary outcomes. A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I–III POP.

Question: Do measures of state anxiety and trait anxiety in people with acute low back pain (ALBP) improve prediction of chronic low back pain (CLBP), defined as pain or pain-related disability at 12 weeks? Design: Observational multi-centre prospective cohort study in primary physiotherapy care with measurements at baseline and at 12 weeks of state and trait anxiety, as well as other established prognostic factors for CLBP. Participants: People with nonspecific ALBP, aged 18 to 60 years, who had been pain free for ≥ 3 months before their current ALBP, and who were being treated according the Dutch clinical guidelines. Outcome measures and analysis: CLBP was defined as a pain score ≥ 3/10 on the Numerical Pain Rating Scale (primary outcome), and as a pain-related disability score ≥ 19/70 on the Pain Disability Inventory. Univariate and multivariate logistic regression analyses estimated how the risk of CLBP differed with state and trait anxiety and other established prognostic factors. Results: Most (204 of 225) participants completed both assessments. State anxiety was an independent predictor of CLBP, whether defined as pain or pain-related disability at 12 weeks, in contrast to trait anxiety. State anxiety improved the predictive performance of the model, with area under the curve (AUC) increasing from 0.64 (95% CI 0.56 to 0.71) to 0.75 (95% CI 0.68 to 0.82) and Nagelkerke’s R2 increasing from 0.08 to 0.24 for the primary outcome measure, pain. For the secondary outcome measure, pain-related disability: AUC 0.63 (95% CI 0.54 to 0.72) improved to 0.73 (95% CI 0.65 to 0.82) and Nagelkerke’s R2 increased from 0.05 to 0.16. Adding trait anxiety to the prognostic model for pain improved the AUC from 0.64 (95% CI 0.56 to 0.71) to 0.70 (95% CI 0.62 to 0.77) and Nagelkerke’s R2 from 0.08 to 0.15. Conclusion: State anxiety in patients with ALBP improved prediction of CLBP, defined as pain and pain-related disability at 12 weeks. Key words: Spinal low back pain, Anxiety, Prognostic factor, Risk, Prediction, Psychological

Background: Parkinson’s disease (PD) is one of the most common neurological disorders, of insidious onset, with major motor symptomatology including bradykinesia, rest tremor, rigidity, and postural disturbances. Virtual reality (VR) and motor imagery (MI) are among the more innovative techniques for the rehabilitation of patients with PD which promote motor learning both through explicit and implicit processes. This study is unique in that it will examine the combined effects of VR and MI on motor function, balance and activities of daily living (ADLs) in patients with PD. Objective: The aim of this work is to investigate the effects of VR with MI techniques in addition to routine physical therapy on motor function, balance, and ADLs in patients with PD. Methods: This is a two-armed parallel design, single-blinded (assessor blinded), single-centered, randomized controlled trial, and the study protocol is based on SPIRIT guidelines. Thirty-four patients with PD (Modified Hoehn and Yahr stages I–III) will be randomly allocated with a 1:1 ratio into Group A (control group) and Group B (treatment group). Group A will be given routine physical therapy in 40-min sessions and 20 min of walking and cycling with a short period of rest, every alternate day (3 days per week) for 12 weeks, while for Group B routine physical therapy protocols along with VR and MI will be used in 60-min sessions, every alternate day (3 days per week) for 12 weeks. The primary outcome measures are as follows: (i) the Unified PD Rating Scale (UPDRS; part III), (ii) the Berg Balance Scale (BBS), and the Activities-Specific Balance Confidence Scale (ABC). The secondary outcome measure is the UPDRS (part II). Assessments will be recorded at baseline, the sixth and twelfth weeks of therapy, and 1 month after the discontinuation of therapy. Clinical Study Registration: This randomized controlled prospective study was registered with the Iranian Registry of clinical trials (IRCT20200221046567N1) on April 1, 2020 (https://www.irct.ir/trial/46073).

Background . Periodontitis and rheumatoid arthritis have similar epidemiology and pathophysiology. Understanding the interaction between these two diseases is vital in our settings. We set out to assess the effect of oral hygiene interventions on disease activity of rheumatoid arthritis patients with periodontitis in Kampala, Uganda. Methods. Fifty-eight patients attending an arthritis clinic with rheumatoid arthritis and periodontitis were randomly assigned to either an intervention group or a control group. Patients diagnosed with rheumatoid arthritis at least two years before, who were on the same medication, dose, or formulation for RA treatment during the preceding three months, were included. The patients were >18 years of age, would be available for all the study visits in the next six months, had at least six natural teeth, had periodontal disease classified as Dutch Periodontal Index (DPSI) >3 and provided written informed consent. Those who had a chronic disorder requiring chronic or intermittent use of antibiotics, were pregnant, were lactating, or had intent to become pregnant were excluded. The primary outcome measure was a change in Disease Activity Score of 28 Joints (DAS28 score) in two 3-month follow-up periods after the intervention. The secondary outcome measure was a change in periodontal status. Results. There was a statistically significant improvement in the DAS-28 score in both the intervention and control arms during the follow-up period (PConclusion. Oral hygiene interventions given to RA patients could drastically improve their RA treatment outcomes, especially in resource-limited settings.

STUDY QUESTION Do the ICSI-related procedural timings and operators affect the outcomes of an ART cycle? SUMMARY ANSWER The ICSI-related timings and operators do not associate with the mean blastulation rate per cohort of inseminated oocytes and the cumulative delivery rate per concluded cycle, except for a mild association between the times from induction of ovulation to oocyte denudation and the former outcome. WHAT IS KNOWN ALREADY In ART, specific timings, protocols and conditions must be complied with to preserve gamete developmental and reproductive competence during the required manipulations. ICSI represents a groundbreaking advancement that has been widely implemented. Nevertheless, the studies that examined the putative impact of ICSI-related procedural timings were mainly conducted in old-fashioned settings or in good prognosis patients. No report addressed issues like operators’ skills and experience and uncertainties exist dealing with the effect of cumulus cells in the pre-incubation period in vitro before ICSI. However, all this information is crucial to efficiently plan the daily routine of an IVF lab, fill the existing gaps of knowledge and define proper key performance indicators. STUDY DESIGN, SIZE, DURATION Observational study conducted at a private IVF clinic (January 2016 to January 2018). We included all consecutive ICSI procedures (n = 1084 infertile couples undergoing 1444 cycles with or without preimplantation genetic testing (PGT); mean ± SD maternal age: 38.1 ± 4.0 years) with fresh autologous oocytes (n = 7999 oocytes, 5.5 ± 3.2 per treatment) inseminated with fresh non-donor ejaculated sperm. All operators and critical procedural timings (induction of ovulation to oocyte denudation, denudation and ICSI) were automatically recorded through an electronic witnessing system. The primary outcome measure was the cumulative delivery rate among both non-PGT and PGT-concluded cycles (i.e. delivery achieved or no supernumerary cryopreserved blastocyst available). The secondary outcome measure was the mean blastulation rate per cohort of inseminated oocytes. All confounders were registered and included in generalized linear models and multivariate logistic regression analyses. PARTICIPANTS/MATERIALS, SETTING, METHODS Fourteen and 12 operators were involved in denudation and ICSI procedures, respectively. Denudation was performed after 4.1 ± 1.2 h (2–7) of pre-incubation in vitro after oocyte retrieval, and ICSI was started immediately after. Beyond procedural timings and operators, all the putative confounders (patients’ and cycles’ characteristics) on the primary and/or secondary outcomes were systematically registered and included in the statistical analyses. MAIN RESULTS AND THE ROLE OF CHANCE The mean time from induction of ovulation to oocyte denudation was 39.3 ± 1.3 h. The mean procedural timings for denudation and ICSI were 8.1 ± 3.8 and 12.6 ± 6.4 min; both these variables were significantly dependent on the number of inseminated oocytes and the operators’ skills and experience. The overall mean blastulation rate per cohort of inseminated oocytes was 34.0 ± 27.9%. This outcome was significantly associated with the time from induction of ovulation to oocyte denudation (mean blastulation rate stable in the time interval 38–42 h, but significantly higher for timings LIMITATIONS, REASONS FOR CAUTION This is a single private IVF center study. Its reproducibility should be assessed in different laboratory conditions, with different protocols and in the hands of different operators. Moreover, specific studies are warranted to address the beneficial/detrimental effect of the other putative confounders under investigation (e.g. kind of ovulation trigger, culture media, incubator, etc.). WIDER IMPLICATIONS OF THE FINDINGS Proactive communication between the embryologists and the clinicians might contribute to a reasoned and more efficient organization of the daily workload and increase the mean blastulation rate, especially when poor prognosis couples (advanced maternal age, reduced sperm count and/or ovarian reserve) are treated. STUDY FUNDING/COMPETING INTEREST(S) No funding. The authors declare no conflict of interest related to the present study.

Background There are few studies reporting the outcomes from arthroscopic shoulder stabilisation using all-suture soft anchors. The aim of this study was to assess the clinical outcomes and failure rate for arthroscopic shoulder stabilisation using these anchors. Methods A retrospective cohort analysis of a consecutive series of patients in a single unit undergoing arthroscopic shoulder stabilisation using JuggerKnot all-suture soft anchors by four consultant shoulder surgeons was performed. Exclusion criteria were revision procedures, engaging Hill-Sachs lesions and glenoid bone loss greater than 20%. The primary outcome measure was failure (dislocation or subluxation as perceived by the patient with subsequent revision surgery). The secondary outcome measure was function as assessed by the Oxford Shoulder Instability Score (OSIS). Results 67 patients with a mean age at the time of surgery of 32.6 years (range 15–55 years) met the inclusion criteria. Median follow up was 34.5 months (minimum 13 months). No patient experienced a postoperative dislocation. However, three patients experienced painful subluxations; two underwent revision arthroscopic stabilisation and one required open stabilisation due to glenoid bone loss. Consequently, failure rate was 4.5%. Mean post-operative OSIS was 39/48 (n = 49). Conclusion This series supports the use of all-suture soft anchors in arthroscopic shoulder stabilisation. The failure rate compares favourably with that previously reported in literature for conventional anchors. Level of evidence Level IV: Case series with no comparison group.

Several studies have found evidence of altered cortisol levels in patients with posttraumatic stress disorder (PTSD). Based on these findings, it is assumed that these patients may show signs of cortisol dysregulation after trauma. Posttrauma cortisol levels are thus considered a potential biomarker of PTSD. However, longitudinal studies using indicators of long-term cortisol secretion (such as hair cortisol concentrations; HCC) are scarce. The current study investigated prospective associations between HCC and PTSD symptoms in a sample of Dutch firefighters taking into account varying levels of work-related trauma severity. In addition, we assessed posttraumatic sleep disturbances as a secondary outcome measure to investigate whether effects generalize to this frequent comorbidity of PTSD. Three hundred seventy-one Dutch firefighters with a mean of 14.01 years of work experience were included in the analyses. Baseline assessment included the collection of hair samples and the measurement of work-related trauma severity, PTSD symptoms, and sleep disturbances. PTSD symptoms and sleep disturbance were re-assessed after six and twelve months. Multilevel analyses indicate a significant positive correlation between HCC and baseline PTSD symptoms in those with average or above-average work-related trauma severity. A similar pattern was evident for posttraumatic sleep disturbances at baseline. Moreover, higher HCC predicted more posttraumatic sleep disturbances after 6 months in participants with above-average work-related trauma severity. No other associations emerged for PTSD symptoms or posttraumatic sleep disturbances at six or twelve months. As such, our study supports the existence of a cross-sectional association between HCC and trauma symptoms, which may vary for different levels of subjective trauma severity. The longitudinal stability of this association should be reinvestigated by future research.

Background: Ligustrazine injection has been widely used as adjunctive therapy in the treatment of acute cerebral infarction (ACI) during the past decades in China, but its clinical efficacy is not yet well confirmed. This study aims to evaluate the efficacy of ligustrazine injection as adjunctive therapy for ACI.Methods: Databases including China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), PubMed, Medline, Google Scholar, Chinese Biomedical Literature Database, Cochrane Library, Embase, Sino-Med, Wanfang Database, and Chinese Science Citation Database were systematically searched for the published randomized controlled trials (RCTs) on ligustrazine injection in the treatment of ACI until November 2020. Meta-analysis was performed on the primary outcome measure (i.e., clinical effective rate) and the secondary outcome measure [i.e., neurological deficit score (NDS), fibrinogen, low shear blood viscosity (LBV), and high shear blood viscosity (HBV)]. The quality of the included RCTs was assessed according to the M scoring system (the refined Jadad scale). Sensitivity analysis and subgroup analysis were conducted according to the methodological quality, years of publication, and sample size.Results: Nineteen RCTs, containing 2022 patients, were included in this study. Meta-analysis indicated that ligustrazine injection combined with Western medicine could achieve a better effect in the treatment of ACI than using Western medicine alone in terms of clinical effective rate (RR = 1.24; 95% CI, 1.19–1.29), NDS (MD = −3.88; 95%CI, −4.51 to −3.61), fibrinogen (MD = −0.59; 95% CI, −0.76 to −0.42), LBV (MD = −2.11; 95% CI, −3.16 to −1.06), and HBV (MD = −0.88; 95% CI, −1.20 to −0.55).Conclusions: This research indicated that ligustrazine injection as adjunctive therapy seemed to be more effective than using western medicine alone in treating ACI. However, more evidence is required to confirm the efficacy of ligustrazine injection due to the low methodological quality of the included RCTs.

ObjectiveThis study aims to determine the prevalence of joint pain and its association with demographic, socioeconomic and behavioural factors in Nepal.DesignThe study was a national cross-sectional population-based study.SettingWe used the most recent nationally representative population-based cross-sectional health survey, The WHO STEPwise approach to surveillance (STEPS) survey, 2019 from all seven provinces of Nepal including both urban and rural areas.ParticipantsThe participants were men and women aged 15–69 years, who were usual residents of the households for at least 6 months and have stayed the night before the survey.Primary and secondary outcome measuresPrimary outcome in this study was prevalence of joint pain. The secondary outcome measure was factors associated with joint pain in Nepal. Joint pain in our study was based on any self-reported symptoms of joint pain, stiffness and swelling lasting for more than 1 month in the past 12 months. Data were weighted to generate national estimates.ResultsThe prevalence of self-reported joint pain in Nepal was 17% (95% CI 14.3% to 20.2%) with higher prevalence for older adults, females, ever married, none/less than primary education, smoker, lowest wealth quintile, homemaker, those with sufficient physical activity and those living in the Karnali province of Nepal. In multivariable analysis self-reported joint pain was found to be associated with advanced age (adjusted OR (AOR)=2.36; 95% CI 1.56 to 3.55), sex (AOR=1.47; 95% CI 1.19 to 1.82) and sufficient physical activity (AOR=0.40; 95% CI 0.25 to 0.65).ConclusionsThe results showed a high prevalence of joint pain in Nepal. Considering the process of ageing and rapid growth in non-communicable disease, this study warrants the need for health policies directed to prevention, treatment and rehabilitation for people affected by chronic musculoskeletal conditions addressing related disabilities and loss of work in Nepal.

IntroductionAlthough antibiotic use and antimicrobial resistance in the Netherlands is comparatively low, inappropriate prescription of antibiotics is substantial, mainly for respiratory tract infections (RTIs). General practitioners (GPs) experience pressure from patients with an immigration background to prescribe antibiotics and have difficulty communicating in a culturally sensitive way. Multifaceted interventions including communication skills training for GPs are shown to be most effective in reducing antibiotic prescription. The PARCA study aims to reduce the number of antibiotic prescriptions for RTIs through implementing a culturally sensitive communication intervention for GPs and evaluate it in a randomised controlled trial (RCT).Methods and analysisA non-blinded RCT including 58 GPs (29 for each arm). The intervention consists of: (1) An E-learning with 4 modules of 10–15 min each; (2) A face-to-face training session in (intercultural) communication skills including role plays with a training actor and (3) Availability of informative patient-facing materials that use simple words (A2/B1 level) in multiple languages. The primary outcome measure is the number of dispensed antibiotic courses qualifying for RTIs in primary care, per 1000 registered patients. The secondary outcome measure is the number of all dispensed antibiotic courses, per 1000 registered patients. The intervention arm will receive the training in Autumn 2021, followed by an observation period of 6 winter months for which numbers of antibiotics will be collected for both trial arms. The GPs/practices in the control arm can attend the training after the observation period.Ethics and disseminationThe study protocol was approved by the Medical Ethics Review Committee of Erasmus MC, University Medical Center Rotterdam (MEC-2020-0142). The results of the trial will be published in international peer-reviewed scientific journals and will be disseminated through national and international congresses. The project is funded by The Netherlands Organisation for Health Research and Development (ZonMw).Trial registration numberNL9450.