Nevin Manimala

Orthop Surg. 2023 May 10. doi: 10.1111/os.13738. Online ahead of print.

ABSTRACT

OBJECTIVE: Three-column osteotomy (3CO) is considered valuable and increasingly utilized in the surgical treatment of severe spine deformity while associated with high implant-related complications and revision risks. This study aims to evaluate the feasibility and clinical outcomes of satellite rod fixation used around the rod-fracture area in revision surgery due to rod fracture after 3CO.

METHODS: Twenty-five patients applying satellite rod fixation in revision surgery from August 2012 to May 2016 were retrospectively reviewed as the SR group. Patients undergoing revision surgery with traditional strategy after 3CO due to rod-fracture were selected as the TR group. Cobb angle, distance between C₇ plumb line and center sacral vertical line (C₇ PL-CSVL), global kyphosis (GK) and sagittal vertical axis (SVA) were assessed. Patients were required to fulfill the Scoliosis Research Society-22 questionnaire (SRS-22) at pre-revision and the last follow-up. The paired t test was used to analyze the difference among pre-revision, post-revision and last follow-up.

RESULTS: There was no statistical difference in terms of age, gender, body mass index (BMI), fusion level at 1st surgery, and follow-up period between SR and TR group (all P > 0.05). The operation time (1.5 ± 0.7 h vs 3.2 ± 0.9 h, P < 0.001) and intraoperative blood loss (178 ± 51 mL vs 324 ± 96 mL, P < 0.001) were significantly higher in the TR group. Patients in both groups obtained obvious deformity correction after revision surgery. For patients in SR group, the coronal Cobb angle significantly improved from 27.9 ± 21.5° at pre-revision to 21.8 ± 16.6° at post-revision (P = 0.034). The C₇ PL-CSVL decreased from 22.6 ± 14.3 mm to 21.3 ± 10.9 mm (P = 0.719). Similarly, improvement was attained in post-revision GK (25.8 ± 17.0° vs 20.2 ± 15.1°, P = 0.061). SVA was corrected from 35.6 ± 33.9 mm to 30.8 ± 24.3 mm after revision (P = 0.182). At the last follow-up, no significant correction loss was observed in both coronal and sagittal parameters (all P > 0.05). All patients responded to the SRS-22 questionnaire and all the domains showed improvements in different levels. As compared to the TR group, the SR group had significantly better pain and management satisfaction scores (all P < 0.05). Additionally, there was no reoccurrence of implant failure during follow-up and all patients achieved solid bony fusion in SR group.

CONCLUSION: Satellite rod fixation around rod-fracture area is indicated for patients in the requirement of revision surgeries due to rod fracture after 3CO. Compared with traditional revision strategies, revision surgery with satellite rods, if patients are selected adequately, is a simpler procedure with less intraoperative blood loss and shorter operating time.

PMID:37165715 | DOI:10.1111/os.13738

Acta Anaesthesiol Scand. 2023 May 10. doi: 10.1111/aas.14263. Online ahead of print.

ABSTRACT

BACKGROUND: Aneurysmal subarachnoid haemorrhage (aSAH) is a life-threatening disease caused by rupture of an intracranial aneurysm. A common complication following aSAH is hydrocephalus, for which placement of an external ventricular drain (EVD) is an important first-line treatment. Once the patient is clinically stable, the EVD is either removed or replaced by a ventriculoperitoneal shunt. The optimal strategy for cessation of EVD treatment is, however, unknown. Gradual weaning may increase the risk of EVD-related infection, whereas prompt closure carries a risk of acute hydrocephalus and redundant shunt implantations. We designed a randomised clinical trial comparing the two commonly used strategies for cessation of EVD treatment in patients with aSAH.

METHODS: DRAIN is an international multi-centre randomised clinical trial with a parallel group design comparing gradual weaning versus prompt closure of EVD treatment in patients with aSAH. Participants are randomised to either gradual weaning which comprises a multi-step increase of resistance over days, or prompt closure of the EVD. The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, or ventriculostomy-related infection. Secondary outcomes are serious adverse events excluding mortality, functional outcome (modified Rankin scale), health-related quality of life (EQ-5D) and Fatigue Severity Scale (FSS). Outcome assessment will be performed 6 months after ictus. Based on the sample size calculation (event proportion 80% in the gradual weaning group, relative risk reduction 20%, type I error 5%, power 80%), 122 patients are needed in each intervention group. Outcome assessment for the primary outcome, statistical analyses and conclusion drawing will be blinded.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03948256.

PMID:37165711 | DOI:10.1111/aas.14263

Eur Heart J. 2023 May 11:ehad279. doi: 10.1093/eurheartj/ehad279. Online ahead of print.

ABSTRACT

Large-scale clinical trials are essential in cardiology and require rapid, accurate publication, and dissemination. Whereas conference presentations, press releases, and social media disseminate information quickly and often receive considerable coverage by mainstream and healthcare media, they lack detail, may emphasize selected data, and can be open to misinterpretation. Preprint servers speed access to research manuscripts while awaiting acceptance for publication by a journal, but these articles are not formally peer-reviewed and sometimes overstate the findings. Publication of trial results in a major journal is very demanding but the use of existing checklists can help accelerate the process. In case of rejection, procedures such as easing formatting requirements and possibly carrying over peer-review to other journals could speed resubmission. Secondary publications can help maximize benefits from clinical trials; publications of secondary endpoints and subgroup analyses further define treatment effects and the patient populations most likely to benefit. These rely on data access, and although data sharing is becoming more common, many challenges remain. Beyond publication in medical journals, there is a need for wider knowledge dissemination to maximize impact on clinical practice. This might be facilitated through plain language summary publications. Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians. This underscores the importance of ensuring that the information is understandable, accessible, balanced, and trustworthy. This report is based on discussions held on December 2021, at the 18th Global Cardiovascular Clinical Trialists meeting, involving a panel of editors of some of the top medical journals, as well as members of the lay press, industry, and clinical trialists.

PMID:37165687 | DOI:10.1093/eurheartj/ehad279

Exp Neurobiol. 2023 Apr 30;32(2):110-118. doi: 10.5607/en23003.

ABSTRACT

Complex regional pain syndrome (CRPS) is a chronic neuropathic pain disorder. Pain catastrophizing, characterized by magnification, rumination, and helplessness, increases perceived pain intensity and mental distress in CRPS patients. As functional connectivity patterns in CRPS remain largely unknown, we aimed to investigate functional connectivity alterations in CRPS patients and their association with pain catastrophizing using a whole-brain analysis approach. Twenty-one patients with CRPS and 49 healthy controls were included in the study for clinical assessment and resting-state functional magnetic resonance imaging. Between-group differences in whole-brain functional connectivity were examined through a Network-based Statistics analysis. Associations between altered functional connectivity and the extent of pain catastrophizing were also assessed in CRPS patients. Relative to healthy controls, CRPS patients showed higher levels of functional connectivity in the bilateral somatosensory subnetworks (components 1~2), but lower functional connectivity within the prefronto-posterior cingulate (component 3), prefrontal (component 4), prefronto-parietal (component 5), and thalamo-anterior cingulate (component 6) subnetworks (p<0.05, family-wise error corrected). Higher levels of functional connectivity in components 1~2 (β=0.45, p=0.04) and lower levels of functional connectivity in components 3~6 (β=-0.49, p=0.047) were significantly correlated with higher levels of pain catastrophizing in CRPS patients. Higher functional connectivity in the somatosensory subnetworks implicating exaggerated pain perception and lower functional connectivity in the prefronto-parieto-cingulo-thalamic subnetworks indicating impaired cognitive-affective pain processing may underlie pain catastrophizing in CRPS.

PMID:37164651 | DOI:10.5607/en23003

Psychogeriatrics. 2023 May 10. doi: 10.1111/psyg.12974. Online ahead of print.

ABSTRACT

BACKGROUND: The number of elderly with mental disorders is increasing, but few studies have been concerned with the physical condition and activities of daily living (ADL) of these patients. This study aims to describe the physical condition and ADL of patients with mental illnesses (PMI) from different age groups, which provides evidence to improve mental health services for PMI.

METHODS: In this prospective cross-sectional study, the samples were divided into three groups of less than 60 years old (group 1), 60-74 years old (group 2), and over 75 years old (group 3) for comparison. Participants’ ADL and physical condition were measure by Barthel Index (BI), Functional Activities Questionnaire (FAQ), Standardised swallowing assessment (SSA) and Short Form of Mini Nutrition Assessment (MNA-SF). The Brief Psychiatric Rating Scale (BPRS) and the Mini-Mental State Examination (MMSE) were used to measure psychological condition.

RESULTS: Totally, 392 participants had been recruited, meanwhile 86% of them were diagnosed with at least one physical disease. There were statistically significant differences in the three groups of participants in BI (F = 50.603, P < 0.001), FAQ (F = 40.332, P < 0.001), SSA (F = 28.574, P < 0.001), and MNA-SF (F = 18.366, P < 0.001). Group 2 and group 3 had significantly lower scores in BI and FAQ than group 1, and the SSA scores were significantly higher than the participants in group 1. In the negative symptoms subscale of BPRS, the mean score of group 3 was significantly higher than groups 1 and 2. Negative symptom subscale has different degrees of correlation with BI (r = -0.537), FAQ (r = 0.643), SSA (r = 0.480), MNA (r = -0.325) and MMSE (r = 0.607). In addition, the participants with comorbidities were related to BI (r = -0.364).

CONCLUSION: Somatic comorbidities play a pivotal role in the clinical characteristics of elderly patients with mental illness, thus greater effort should be paid to elderly patients suffering from mental illness with dysphagia, malnutrition, and cognitive decline. Further, the negative symptoms of elderly patients with mental disorders also deserve attention.

PMID:37164643 | DOI:10.1111/psyg.12974

J Med Genet. 2023 May 10:jmg-2023-109146. doi: 10.1136/jmg-2023-109146. Online ahead of print.

ABSTRACT

BACKGROUND: A 12-nucleotide RIPOR2 in-frame deletion was recently identified as a relatively common and highly penetrant cause of autosomal dominant non-syndromic sensorineural hearing loss, type DFNA21, in the Netherlands. The associated hearing phenotype is variable. The allele frequency (AF) of 0.039% of this variant was determined in a local cohort, and the reported phenotype may be biased because studied families were identified based on index patients with hearing loss (HL). In this study, we determine the AF in a cohort from a different geographical region of the Netherlands. Additionally, we examine the hearing phenotype in individuals with the variant but not selected for HL.

METHODS: The AF was determined in participants of the Rotterdam Study (RS), a large cohort study. The phenotype was characterised using individual clinical hearing data, including audiograms.

RESULTS: The observed AF in the RS cohort was 0.072% and not statistically significantly different from the previously observed 0.039%. The AF in the two cohorts combined was 0.052%. Consistent with previous findings, we found a highly variable audiometric phenotype with non-penetrance of HL in 40% of subjects aged 55-81, which is higher than the 10% at age 50 previously observed.

CONCLUSION: We found an overall higher AF and lower penetrance than previously reported, confirming that DFNA21 is relatively common in the Netherlands. This supports its potential suitability as a target for therapeutic development. Studying possible modifying factors is essential to explain the phenotypical variability and to identify patients eligible for such a therapy.

PMID:37164627 | DOI:10.1136/jmg-2023-109146

Br J Sports Med. 2023 May 10:bjsports-2022-106681. doi: 10.1136/bjsports-2022-106681. Online ahead of print.

ABSTRACT

BACKGROUND: Long-lasting effects of COVID-19 may include cardiovascular, respiratory, skeletal muscle, metabolic, psychological disorders and persistent symptoms that can impair health-related quality of life (HRQoL). We investigated the effects of a home-based exercise training (HBET) programme on HRQoL and health-related outcomes in survivors of severe/critical COVID-19.

METHODS: This was a single-centre, single-blinded, parallel-group, randomised controlled trial. Fifty survivors of severe/critical COVID-19 (5±1 months after intensive care unit discharge) were randomly allocated (1:1) to either a 3 times a week (~60-80 min/session), semi-supervised, individualised, HBET programme or standard of care (CONTROL). Changes in HRQoL were evaluated through the 36-Item Short-Form Health Survey, and physical component summary was predetermined as the primary outcome. Secondary outcomes included cardiorespiratory fitness, pulmonary function, functional capacity, body composition and persistent symptoms. Assessments were performed at baseline and after 16 weeks of intervention. Statistical analysis followed intention-to-treat principles.

RESULTS: After the intervention, HBET showed greater HRQoL score than CONTROL in the physical component summary (estimated mean difference, EMD: 16.8 points; 95% CI 5.8 to 27.9; effect size, ES: 0.74), physical functioning (EMD: 22.5 points, 95% CI 6.1 to 42.9, ES: 0.83), general health (EMD: 17.4 points, 95% CI 1.8 to 33.1, ES: 0.73) and vitality (EMD: 15.1 points, 95% CI 0.2 to 30.1, ES: 0.49) domains. 30-second sit-to-stand (EMD: 2.38 reps, 95% CI 0.01 to 4.76, ES: 0.86), and muscle weakness and myalgia were also improved in HBET compared with CONTROL (p<0.05). No significant differences were seen in the remaining variables. There were no adverse events.

CONCLUSION: HBET is an effective and safe intervention to improve physical domains of HRQoL, functional capacity and persistent symptoms in survivors of severe/critical COVID-19.

TRIAL REGISTRATION NUMBER: NCT04615052.

PMID:37164620 | DOI:10.1136/bjsports-2022-106681

Eur J Cancer. 2023 Apr 7;187:134-143. doi: 10.1016/j.ejca.2023.03.034. Online ahead of print.

ABSTRACT

PURPOSE: Unresectable, locally advanced sinonasal epithelial tumours are rare diseases with poor prognosis. Multimodal approach is widely used, although no standard therapy has been established in prospective trials. This study assessed activity and safety of an innovative integration of multimodality treatment-induction chemotherapy (ICT), surgery and radiotherapy (RT)-modulated by histology and response to ICT.

METHODS: Patients with untreated, unresectable sinonasal epithelial tumours with selected histotypes (squamous cell carcinoma, intestinal-type adenocarcinoma, sinonasal undifferentiated and neuroendocrine carcinoma, olfactory neuroblastoma) were enroled in a single-arm, open-label, phase II, multicentre clinical trial. Patients were treated with up to 5 ICT cycles, whose regimen was selected according to histotype. Photon and/or proton/carbon-ion-based RT was employed according to disease site, stage and ICT response. Primary end-point was 5-years progression-free survival (PFS), secondary end-points were overall survival (OS), ICT objective response rate per RECIST 1.1 and safety.

RESULTS: Twenty-five patients were evaluable for primary end-point. Five-year PFS was 26.8% (95% confidence interval [CI]: 12.6-57.1), with a median PFS of 18 months. Five-year OS was 23.8% (95% CI: 9.5-59.3), with a median OS of 27 months. The overall response rate to ICT was 40%. Three-year PFS for patients achieving major volumetric partial response (mPRv) versus non-mPRv was 40% (95% CI: 13.7-100%) versus 23.1% (95% CI: 8.3-64.7%) (P = 0.318) and 3-year OS was 53.3% (95% CI: 21.4-100%) versus 37.7% (95% CI: 20.0-71.0%) (P = 0.114).

CONCLUSION: Multimodal combination of ICT and innovative RT did not provide a significant improvement in survival rates with respect to previous experiences. This finding underscores the need for future research in this rare disease, still characterised by a heavy burden and poor prognosis. We observed longer survival in subjects achieving response to ICT. The overall treatment safety is acceptable.

PMID:37163806 | DOI:10.1016/j.ejca.2023.03.034

Mar Pollut Bull. 2023 May 8;192:115004. doi: 10.1016/j.marpolbul.2023.115004. Online ahead of print.

ABSTRACT

The entire human race is struggling with the spread of COVID-19. Worldwide, the wearing of face masks is indispensable to prevent such spread. Despite numerous studies reporting on the fabrication of face masks and surgical masks to reduce spread and thus human deaths, this novel work is considered the marine waste of microplastics, namely Polypropylene (PP) polymer, used to fabricate non-woven fabric masks through the melt-blown process. This experimental work aims to maximize the mask’s quality and minimize its fabrication cost by optimizing the melt-blown process parameters and using microplastics. The melt-blown process was used to make masks. Parameters such as extruder temperature, hot air temperature, melt flow rate, and die-to-collector distance (DCD) were investigated as independent variables. The quality of the mask was investigated in terms of bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), and differential pressure. The Taguchi L16 orthogonal array and Taguchi analysis were employed for experimental design and statistical optimization, respectively. The results reveal that the higher BFE and PFE are recorded at 96.7 % and 98.6 %, respectively. The surface morphological investigation on different layers ensured the fine and uniform porosity of the layers and exhibited minimum breath resistance (a low differential pressure of 0.00152 kPa/cm²). Hence the chemically treated marine waste microplastics improved the masks’ performance.

PMID:37163794 | DOI:10.1016/j.marpolbul.2023.115004

Public Health. 2023 May 8;219:110-116. doi: 10.1016/j.puhe.2023.03.023. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to (1) provide a comprehensive overview of contraceptive methods self-reported by men in England, over 5 years, focusing on condoms in comparison to any male method; and (2) explore condom as a contraceptive method by region and ethnicity.

STUDY DESIGN: Data were from the Sexual and Reproductive Health Services (Contraception) England census data set from 2014/15 to 2018/19. Once missing data were removed, this left a total of 365,292 men. Two binomial logistic regression models were performed. Model 1 examined ethnicity, region, and time on condom as a method of contraception; and Model 2 examined ethnicity, region, and time by any male contraceptive. Descriptive statistics were run for natural family planning and spermicide.

RESULTS: Model 1 revealed a significant model, χ² (15) = 30,976, P < 0.001, and predicted that condoms as a method decreased in London with a greater decrease in Midlands. London saw the lowest rate of decline among the non-White ethnic group, whereas North and South regions increased probability over time. The North started at a higher probability and the South at the lowest. Model 2 also revealed a significant model, χ² (15) = 32,472, P < 0.001, with a similar pattern to Model 1. Contingency tables showed natural family planning and spermicide were the least reported methods and decreased over time.

CONCLUSIONS: As any male contraceptive method appears to be decreasing in both models, reproductive health promotion is required. This study has implications for commissioning funds and for identifying regional areas of further investigation.

PMID:37163786 | DOI:10.1016/j.puhe.2023.03.023