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PURPOSE: This study aimed to implement the Quality of Care (QoC) Assessment Tool from the National Spinal Cord/Column Injury Registry of Iran (NSCIR-IR) to map the current state of in-hospital QoC of individuals with Traumatic Spinal Column and Cord Injuries (TSCCI). METHODS: The QoC Assessment Tool, developed from a scoping review of the literature, was implemented in NSCIR-IR. We collected the required data from two primary sources. Questions regarding health system structures and care processes were completed by the registrar nurse reviewing the hospital records. Questions regarding patient outcomes were gathered through patient interviews. RESULTS: We registered 2812 patients with TSCCI over six years from eight referral hospitals in NSCIR-IR. The median length of stay in the general hospital and intensive care unit was four and five days, respectively. During hospitalization 4.2% of patients developed pressure ulcers, 83.5% of patients reported satisfactory pain control and none had symptomatic urinary tract infections. 100%, 80%, and 90% of SCI registration centers had 24/7 access to CT scans, MRI scans, and operating rooms, respectively. Only 18.8% of patients who needed surgery underwent a surgical operation in the first 24 h after admission. In-hospital mortality rate for patients with SCI was 19.3%. CONCLUSION: Our study showed that the current in-hospital care of our patients with TSCCI is acceptable in terms of pain control, structure and length of stay and poor regarding in-hospital mortality rate and timeliness. We must continue to work on lowering rates of pressure sores, as well as delays in decompression surgery and fatalities.
Subject(s)
Spinal Cord Injuries , Humans , Iran/epidemiology , Spinal Cord Injuries/epidemiology , Spinal Cord Injuries/surgery , Spine , Hospitals , PainABSTRACT
Despite being relatively rare, pediatric traumatic spinal cord injury (TSCI) is a debilitating event with high morbidity and long-term damage and dependency. This study aims to provide insight on the epidemiological characteristics of pediatric TSCI worldwide. The studies were included if they provided data for the pediatric population with the diagnosis of TSCI. Information sources included PubMed, Embase, Web of Science, and Scopus. All databases were searched from 1990 to April 2023. The quality of included studies was evaluated by Joanna Briggs Institute Critical Appraisal Tools. The results of the meta-analysis were presented as forest plots. PROSPERO Registration code: CRD42020189757. We identified 87 studies from 18 developed and 11 developing countries. Of the 87 studies evaluated, 52 studies were considered medium quality, 27 studies were considered high quality, and 8 studies were considered low quality. In developed countries, the proportion of TSCIs occurring in patients aged 0-15 years was 3% (95% CI: 2.2%; 3.9%), while in developing countries, it was 4.5% (95% CI: 2.8%; 6.4%). In developed countries, the pooled incidence of pediatric TSCI was 4.3/millions of children aged 0-15/year (95% CI: 3.1; 6.0/millions children aged 0-15/year) and boys comprised 67% (95% CI: 63%; 70%) of cases. The most prevalent level of injury was cervical (50% [95% CI: 41%; 58%]). The frequency of SCI Without Obvious Radiological Abnormality (SCIWORA) was 35% (95% CI: 18%; 54%) among children 0-17 years. The most common etiology in developed countries was transport injuries (50% [95% CI: 42%; 57%]), while in developing countries falls were the leading cause (31% [95% CI: 20%; 42%]). The most important limitation of our study was the heterogeneity of studies in reporting age subgroups that hindered us from age-specific analyses. Conclusion: Our study provided accurate estimates for the epidemiology of pediatric TSCI. We observed a higher proportion of pediatric TSCI cases in developing countries compared to developed countries. Furthermore, we identified distinct epidemiological characteristics of pediatric TSCI when compared to adult cases and variations between developing and developed countries. Recognizing these unique features allows for the implementation of cost-effective preventive strategies aimed at reducing the incidence and burden of TSCI in children. What is Known: ⢠Pediatric Traumatic Spinal Cord Injury (TSCI) can have profound physical and social consequences for affected children, their families, and society as a whole. ⢠Epidemiological insights are vital for they provide the data and understanding needed to the identification of vulnerable populations, aiding in the development of targeted prevention strategies and effective resource allocation. What is New: ⢠The estimated incidence of pediatric TSCI in developed countries is 4.3 cases per million children aged 0-15. The proportion of pediatric TSCI cases in relation to all-age TSCI cases is 3% in developed countries and 4.5% in developing countries. ⢠The etiology of TSCI in pediatric cases differs between developing and developed countries. In developed countries, transport injuries are the most prevalent cause of pediatric TSCI, while falls are the least common cause. Conversely, in developing countries, falls are the leading cause of pediatric TSCI.
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Spinal Cord Injuries , Adult , Male , Child , Humans , Female , Spinal Cord Injuries/epidemiology , Spinal Cord Injuries/etiology , Incidence , Databases, FactualABSTRACT
PURPOSE: The proper application of high-quality clinical practice guidelines improves trauma patients' care and outcomes. This study aimed to adopt and adapt guidelines on the timing of decompressive surgery in acute spinal cord injury (SCI) in Iranian clinical settings. METHODS: This study followed a systematic search and review of the literature to enter them into the selection process. The source guidelines' clinical suggestions were converted into clinical scenarios for clinical questions on the timing of decompressive surgery. After summarizing the scenarios, we prepared an initial list of recommendations based on the status of the Iranian patients and the health system. The ultimate conclusion was reached with the help of a national interdisciplinary expert panel comprising 20 experts throughout the country. RESULTS: A total of 408 records were identified. After title and abstract screening, 401 records were excluded, and the full texts of the remaining seven records were reviewed. Based on our screening process, only one guideline included recommendations on the topic of interest. All of the recommendations were accepted by the expert panel with slight changes due to resource availability in Iran. The final two recommendations were the consideration of early surgery (≤24 h) as a treatment option in adult patients with traumatic central cord syndrome and in adult patients with acute SCI regardless of the level of injury. CONCLUSION: Considering early surgery for adult patients with acute traumatic SCI regardless of the level of injury was the final recommendation for Iran. Although most of the recommendations are adoptable in developing countries, issues with infrastructure and availability of resources are the limitations.
Subject(s)
Decompression, Surgical , Spinal Cord Injuries , Adult , Humans , Iran , Decompression, Surgical/adverse effects , Spinal Cord Injuries/surgery , Spinal Cord Injuries/etiologyABSTRACT
PURPOSE: The purpose of the National Spinal Cord Injury Registry of Iran (NSCIR-IR) is to create an infrastructure to assess the quality of care for spine trauma and in this study, we aim to investigate whether the NSCIR-IR successfully provides necessary post-discharge follow-up data for these patients. METHODS: An observational prospective study was conducted from April 11, 2021 to April 22, 2022 in 8 centers enrolled in NSCIR-IR, respectively Arak, Rasht, Urmia, Shahroud, Yazd, Kashan, Tabriz, and Tehran. Patients were classified into three groups based on their need for care resources, respectively: (1) non-spinal cord injury (SCI) patients without surgery (group 1), (2) non-SCI patients with surgery (group 2), and (3) SCI patients (group 3). The assessment tool was a self-designed questionnaire to evaluate the care quality in 3 phases: pre-hospital, in-hospital, and post-hospital. The data from the first 2 phases were collected through the registry. The post-hospital data were collected by conducting follow-up assessments. Telephone follow-ups were conducted for groups 1 and 2 (non-SCI patients), while group 3 (SCI patients) had a face-to-face visit. This study took place during the COVID-19 pandemic. Data on age and time interval from injury to follow-up were expressed as mean ± standard deviation (SD) and response rate and follow-up loss as a percentage. RESULTS: Altogether 1538 telephone follow-up records related to 1292 patients were registered in the NSCIR-IR. Of the total calls, 918 (71.05%) were related to successful follow-ups, but 38 cases died and thus were excluded from data analysis. In the end, post-hospital data from 880 patients alive were gathered. The success rate of follow-ups by telephone for groups 1 and 2 was 73.38% and 67.05% respectively, compared to 66.67% by face-to-face visits for group 3, which was very hard during the COVID-19 pandemic. The data completion rate after discharge ranged from 48% to 100%, 22%-100% and 29%-100% for groups 1 - 3. CONCLUSIONS: To improve patient accessibility, NSCIR-IR should take measures during data gathering to increase the accuracy of registered contact information. Regarding the loss to follow-ups of SCI patients, NSCIR-IR should find strategies for remote assessment or motivate them to participate in follow-ups through, for example, providing transportation facilities or financial support.
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INTRODUCTION: Traumatic spinal cord injury (TSCI) is a catastrophic event with a considerable health and economic burden on individuals and countries. This study was performed to update an earlier systematic review and meta-analysis of epidemiological properties of TSCI in developing countries published in 2013. METHODS: Various search methods including online searching in database of EMBASE and PubMed, and hand searching were performed (2012 to May 2020). The keywords "Spinal cord injury," "epidemiology," "incidence," and "prevalence" were used. Based on the definition of developing countries by the International Monetary Fund, studies related to developing countries were included. Data selection was according to PRISMA guidelines. The quality of included studies was evaluated by Joanna Briggs Institute Critical Appraisal Tools. Results of meta-analysis were presented as pooled frequency, and forest, funnel, and drapery plots. RESULTS: We identified 47 studies from 23 developing countries. The pooled incidence of TSCI in developing countries was 22.55/million/year (95% CI: 13.52; 37.62/million/year). Males comprised 80.09% (95% CI: 78.29%; 81.83%) of TSCIs, and under 30 years patients were the most affected age group. Two leading etiologies of TSCIs were motor vehicle crashes (43.18% [95% CI: 37.80%; 48.63%]) and falls (34.24% [95% CI: 29.08%; 39.59%], respectively). The difference among the frequency of complete injury (49.47% [95% CI: 43.11%; 55.84%]) and incomplete injury (50.53% [95% CI: 44.16%; 56.89%]) was insignificant. The difference among frequency of tetraplegia (46.25% [95% CI: 37.78%; 54.83%]) and paraplegia (53.75% [95% CI: 45.17%; 62.22%]) was not statistically significant. The most prevalent level of TSCI was cervical injury (43.42% [95% CI: 37.38%; 49.55%]). CONCLUSION: In developing countries, TSCIs are more common in young adults and males. Motor vehicle crashes and falls are the main etiologies. Understanding epidemiological characteristics of TSCIs could lead to implant-appropriate cost-effective preventive strategies to decrease TSCI incidence and burden.
Subject(s)
Developing Countries , Spinal Cord Injuries , Female , Humans , Incidence , Male , Paraplegia/epidemiology , Quadriplegia/epidemiology , Spinal Cord Injuries/epidemiology , Young AdultABSTRACT
PURPOSE: Anterior cervical discectomy and fusion (ACDF) is one of the most widely used procedures in cervical spine. Demineralized bone matrix (DBM) is one of the fusion options that has been used in treatment of the bone defects for years. The purpose of this review is to provide an evidence-based analysis on the current evidence for effectiveness of DBM in ACDF. METHODS: A systematic search of the literature was conducted using MEDLINE, Scopus, and CENTRAL. The risk of bias was evaluated with the criteria recommended by the Cochrane Back and Neck group and the Methodological Index for Non-Randomized Studies (MINORS). The patient-reported outcome measures included the visual analog scale (VAS), Odom's criteria, Japanese Orthopaedic Association (JOA), and Neck Disability Index (NDI). Secondary outcome measures were fusion rate, non-union, subsidence, collapse, displacement, spinal alignment, and re-operation. RESULTS: Twelve studies met the eligibility criteria, of which three were randomized and nine were non-randomized. Patient-reported outcomes were non-inferior for DBM compared with the autograft and other bone substitute materials. The DBM had a fusion rate comparable with other graft materials, particularly in long term (88.8-100%, after 18 months follow-up). The majority of studies reported no collapse, subsidence or displacement with DBM. The revision surgery was mainly due to the symptomatic non-union in 4.1-8.3% of the DBM cases. Preservation of the angle of cervical lordosis was acceptable with DBM fusion. CONCLUSIONS: Most of the studies reported non-inferior results for DBM compared with autograft and other graft substitute materials in terms of patient-reported outcomes, fusion rate, and safety. However, the quantity and quality of evidence is very limited.
Subject(s)
Bone Matrix/transplantation , Bone Substitutes/therapeutic use , Bone Transplantation/methods , Cervical Vertebrae/surgery , Diskectomy/methods , Intervertebral Disc Degeneration/surgery , Spinal Fusion/methods , Biocompatible Materials , Humans , Lordosis , Pain Measurement , Transplantation, Autologous , Treatment OutcomeABSTRACT
Objective: To develop a predictive model of incidence of traumatic spinal cord injury (TSCI). Methods: The data for training the model included both the incidence data and the covariates. The incidence data were extracted from systematic reviews and the covariates were extracted from data available in the international road federation database. Then the feature processing measures were taken. First we defined a hyper-parameter, missing-value threshold, in order to eliminate features that exceed this threshold. To tackle the problem of overfitting of model we determined the Pearson correlation of features and excluded those with more than 0.7 correlation. After feature selection three different models including simple linear regression, support vector regression, and multi-layer perceptron were examined to fit the purposes of this study. Finally, we evaluated the model based on three standard metrics: Mean Absolute Error, Root Mean Square Error, and R2. Results: Our machine-learning based model could predict the incidence rate of TSCI with the mean absolute error of 4.66. Our model found "Vehicles in use, Total vehicles/Km of roads", "Injury accidents/100 Million Veh-Km", "Vehicles in use, Vans, Pick-ups, Lorries, Road Tractors", "Inland surface Passengers Transport (Mio Passenger-Km), Rail", and "% paved" as top predictors of transport-related TSCI (TRTSCI). Conclusions: Our model is proved to have a high accuracy to predict the incidence rate of TSCI for countries, especially where the main etiology of TSCI is related to road traffic injuries. Using this model, we can help the policymakers for resource allocation and evaluation of preventive measures.
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BACKGROUND: When treating acute ischemic stroke due to large-vessel occlusion, both mechanical thrombectomy and intravenous (IV) thrombolysis carry the risk of intracerebral hemorrhage. PURPOSE: This study aimed to delve deeper into the risk of intracerebral hemorrhage and its subtypes associated with mechanical thrombectomy with or without IV thrombolysis to contribute to better decision-making in the treatment of acute ischemic stroke due to large-vessel occlusion. DATA SOURCES: PubMed, EMBASE, and Scopus databases were searched for relevant studies from inception to September 6, 2023. STUDY SELECTION: The eligibility criteria included randomized clinical trials or post hoc analysis of randomized controlled trials that focused on patients with acute ischemic stroke in the anterior circulation. After screening 4870 retrieved records, we included 9 studies (6 randomized controlled trials and 3 post hoc analyses of randomized controlled trials) with 3241 patients. DATA ANALYSIS: The interventions compared were mechanical thrombectomy + IV thrombolysis versus mechanical thrombectomy alone, with the outcome of interest being any form of intracerebral hemorrhage and symptomatic intracerebral hemorrhage after intervention. A common definition for symptomatic intracerebral hemorrhage was pooled from various classification systems, and subgroup analyses were performed on the basis of different definitions and anatomic descriptions of hemorrhage. The quality of the studies was assessed using the revised version of Cochrane Risk of Bias 2 assessment tool. Meta-analysis was performed using the random effects model. DATA SYNTHESIS: Eight studies had some concerns, and 1 study was considered high risk. Overall, the risk of symptomatic intracerebral hemorrhage was comparable between mechanical thrombectomy + IV thrombolysis and mechanial thrombectomy alone (risk ratio, 1.24 [95% CI, 0.89-1.72]; P = .20), with no heterogeneity across studies. Subgroup analysis of symptomatic intracerebral hemorrhage showed a non-significant difference between 2 groups based on the National Institute of Neurological Disorders and Stroke (P = .3), the Heidelberg Bleeding Classification (P = .5), the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (P = .4), and the European Cooperative Acute Stroke Study III (P = .7) criteria. Subgroup analysis of different anatomic descriptions of intracerebral hemorrhage showed no difference between the 2 groups. Also, we found no difference in the risk of any intracerebral hemorrhage between two groups (risk ratio, 1.10 [95% CI, 1.00-1.21]; P = .052) with no heterogeneity across studies. LIMITATIONS: There was a potential for performance bias in most studies. CONCLUSIONS: In this systematic review and meta-analysis, the risk of any intracerebral hemorrhage and symptomatic intracerebral hemorrhage, including its various classifications and anatomic descriptions, was comparable between mechanical thrombectomy + IV thrombolysis and mechanical thrombectomy alone.
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With increasing life expectancies and population aging, the incidence of elderly patients with grade 2 and 3 gliomas is increasing. However, there is a paucity of knowledge on factors affecting their treatment selection and overall survival (OS). Geriatric patients aged between 60 and 89 years with histologically proven grade 2 and 3 intracranial gliomas were identified from the National Cancer Database between 2010 and 2017. We analyzed patients' demographic data, tumor characteristics, treatment modality, and outcomes. The Kaplan-Meier method was used to analyze OS. Univariate and multivariate analyses were performed to assess the predictive factors of mortality and treatment selection. A total of 6257 patients were identified: 3533 (56.3 %) hexagenerians, 2063 (32.9 %) septuagenarians, and 679 (10.8 %) octogenarians. We identified predictors of lower OS in patients, including demographic factors (older age, non-zero Charlson-Deyo score, non-Hispanic ethnicity), socioeconomic factors (low income, treatment at non-academic centers, government insurance), and tumor-specific factors (higher grade, astrocytoma histology, multifocality). Receiving surgery and chemotherapy were associated with a lower risk of mortality, whereas receiving radiotherapy was not associated with better OS. Our findings provide valuable insights into the complex interplay of demographic, socioeconomic, and tumor-specific factors that influence treatment selection and OS in geriatric grade 2 and 3 gliomas. We found that advancing age correlates with a decrease in OS and a reduced likelihood of undergoing surgery, chemotherapy, or radiotherapy. While receiving surgery and chemotherapy were associated with improved OS, radiotherapy did not exhibit a similar association.
Subject(s)
Brain Neoplasms , Databases, Factual , Glioma , Humans , Aged , Female , Male , Glioma/therapy , Glioma/mortality , Glioma/epidemiology , Aged, 80 and over , Middle Aged , Brain Neoplasms/therapy , Brain Neoplasms/mortality , Brain Neoplasms/epidemiology , Neoplasm Grading , United States/epidemiology , Socioeconomic FactorsABSTRACT
Studies showed that the respiratory is not the only system affected by coronavirus 2, while cardiovascular, digestive, and nervous systems, as well as essential organs such as the kidneys, can be affected by this virus. In this review, we have studied the epidemiology, clinical, and laboratory findings on COVID-19 infection renal involvement, mortality, physiopathology, remaining renal sequels after recovery, underlying renal disease, and renal injury due to its treatment. Also, protective measures for kidney injury are explained in three levels. Evidence of viral particles and genome in the urine and renal tubular cells and signs of damage such as microangiopathy, hypercoagulopathy, and fibrosis are found in COVID-19 patients. The result of this study showed, in hospitalized COVID-19 patients, that the rate of acute kidney injury (AKI) was up to 46%, with a mortality ranging from 11 to 96%. A considerable proportion of patients with AKI would remain on renal replacement therapy. Proteinuria and hematuria are observed in 87 and 75% patients, and increased Cr and glomerular filtration rate (GFR) <60 ml/min per 1.73 m2 are observed in 29.6 and 35.3% of the patients, respectively. Remedsivir is considered to have adverse effects on GFR. COVID-19 patients need special attention to prevent AKI. Those with underlying chronic kidney disease or AKI need proper and explicit evaluation and treatment to improve their prognosis and decrease mortality, which should not be limited to the hospitalization period.
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Objectives: This review was designed to update our earlier systematic review which evaluated both published and unpublished evidence on the incidence of traumatic spinal cord injury (TSCI) worldwide. Methods: We used various search methods including strategic searching, reference checking, searching for grey literature, contacting registries, authors, and organizations requesting unpublished data, browsing related websites, and hand searching key journals. The quality of included studies was evaluated by Joanna Briggs Institute Critical Appraisal Tools. Records published between April 2013 and May 2020 were added to the original systematic review. Results: Overall, 58 resources including 45 papers, 10 SCI registry reports, 1 book, and 2 theses were retrieved. We found TSCI incidence data for eight new countries, which overall shapes our knowledge of TSCI incidence for 49 countries. The incidence of TSCI ranges from 3.3 to 195.4 cases per million (cpm) based on subnational studies and from 5.1 to 150.48 cpm based on national studies. Most of the studies were low quality, lacked consistent case selection due to unclear definition of TSCI and unclear ascertainment methods. Conclusions: There is an increasing number of publications in the literature focusing on the epidemiologic data of TSCI. The absence of a standard form of reporting TSCI hinders the comparability of data across different data sources. Use of various definitions for TSCI may lead to heterogeneity in reports. Use of sensitivity analyses based on reasonable classification criteria can aid in offering a uniform set of case identification and ascertainment criteria for TSCI.
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STUDY DESIGN: A retrospective study. OBJECTIVES: The quality of care (QoC) for spinal column/cord injury patients is a major health care concern. This study aimed to implement the QoC assessment tool (QoCAT) in the National Spinal Cord/Column Injury Registry of Iran (NSCIR-IR) to define the current state of pre- and post-hospital QoC of individuals with Traumatic Spinal Column and Spinal Cord Injuries (TSC/SCIs). METHODS: The QoCAT, previously developed by our team to measure the QoC in patients with TSC/SCIs, was implemented in the NSCIR-IR. The pre-hospital QoC was evaluated through a retrospective analysis of NSCIR-IR registry data. Telephone interviews and follow-ups of patients with SCI evaluated the QoC in the post-hospital phase. RESULTS: In the pre-hospital phase, cervical collars and immobilization were implemented in 46.4% and 48.5% of the cases, respectively. Transport time from the scene to the hospital was documented as <1 hour and <8 hours in 33.4% and 93.9% of the patients, respectively. Post-hospital indicators in patients with SCI revealed a first-year mortality rate of 12.5% (20/160), a high incidence of secondary complications, reduced access to electrical wheelchairs (4.2%) and modified cars (7.7%), and low employment rate (21.4%). CONCLUSION: These findings revealed a significant delay in transport time to the first care facilities, low use of immobilization equipment indicating low pre-hospital QoC. Further, the high incidence of secondary complications, low employment rate, and low access to electrical wheelchairs and modified cars indicate lower post-hospital QoC in patients with SCI. These findings imply the need for further planning to improve the QoC for patients with TSC/SCIs.
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OBJECTIVE: To develop a comprehensive assessment tool to evaluate the Quality of Care (QoC) in managing individuals with traumatic spinal cord injuries (TSCI). METHOD: At first, the concepts of QoC for TSCI were identified by conducting a qualitative interview along with re-evaluation of the results of a published scoping review (conceptualization). After operationalization of indicators, they were valued by using the expert panel method. Afterward, the content validity index (CVI) and content validity ratio (CVR) were calculated and served as cut-offs for indicator selection. Then specific questions were developed for each indicator and classified into three categories: pre-hospital, in-hospital, and post-hospital. Data availability of the National Spinal Cord Injury Registry of Iran (NSCIR-IR) was subsequently used to design questions that represent indicators in an assessment tool format. The comprehensiveness of the tool was evaluated using a 4-item Likert scale by the expert panel. RESULT: Twelve experts participated in conceptualization and 11 experts participated in operationalization phase. Overall, 94 concepts for QoC were identified from published scoping review (87 items) and qualitative interviews (7 items). The process of operationalization and indicator selection led to the development of 27 indicators with acceptable content validity. Finally, the assessment tool contained three pre-hospital, twelve in-hospital, nine post-hospital, and three mixed indicators. Ninety-one percent of experts evaluated the entire tool as comprehensive. CONCLUSION: Our study presents a health-related QoC tool that contains a comprehensive set of indicators to assess the QoC for individuals with TSCI. However, this tool should be used in various situations to establish construct validity further.
Subject(s)
Quality of Health Care , Spinal Cord Injuries , Humans , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/therapy , Registries , IranABSTRACT
OBJECTIVE: To investigate the predictive factors and the best predictive model for relapse in granulomatosis with polyangiitis (GPA) patients. METHODS: All patients referred to our tertiary university hospital with confirmed diagnosis of GPA based on 1990-ACR criteria and/or revised Chapel Hill nomenclature, who were followed more than 24 months between 2012 and 2021 were included. Patients were classified into relapsing and non-relapsing groups. Disease activity was assessed based on Birmingham Vasculitis Activity Score (BVAS) and BVAS for GPA (BVAS-GPA). All demographic, clinical, laboratory, and radiologic parameters were compared between two groups. RESULTS: Data of 133 patients (male = 52 (39.1%); mean age = 46.5 ± 14.5 years) with a mean follow-up period of 49.4 ± 24.1 months were evaluated. Of those, 91 (68.4%) experienced at least one relapse episode. The mean duration of relapse-free-survival (RFS) was 12.5 months with 1-year, 3-year, and 5-year RFS rates of 46.6%, 34.6%, and 31.6%, respectively. The risk of relapse was higher if patients had higher BVAS or BVAS-GPA score (P-values < 0.001), constitutional syndrome (P-value = 0.01), neutrophil-to-lymphocyte ratio (NLR) (P-value = 0.01), C-reactive-protein (P-value = 0.03), alanine transaminase > 40 units/L (P-value = 0.04), and microscopic hematuria (P-value = 0.001). In backward logistic regression analysis, baseline BVAS score ≥ 12 (Ex(B) = 4.21, P-value = 0.03), and NLR > 2.5 (Ex(B) = 12.00, P-value = 0.007) remained statistically significant at the last step of the model with 75.8% sensitivity, 76.9% specificity, and 76.3% accuracy in predicting the relapsing patients. The frequency of relapse episodes was significantly lower in treatment group of rituximab-rituximab (0.3 ± 0.6) compared to cyclophosphamide-methotrexate (1.2 ± 1.3) and cyclophosphamide-azathioprine (1.8 ± 1.5) treatment protocols (P-value = 0.002). CONCLUSION: High-risk patients according to proposed model should be prioritized for more intensive care, more aggressive treatment, and closer follow-ups. KEY POINTS: ⢠During the mean follow-up period of 50 months, 68.4% experienced at least one relapse episode ⢠Patients with baseline BVAS > 12, renal involvement, and elevated NLR are more vulnerable to relapsing disease ⢠Patients on rituximab for induction and maintenance less experienced relapse episodes compared to other treatment regimens.
Subject(s)
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis , Granulomatosis with Polyangiitis , Microscopic Polyangiitis , Adult , Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy , Antibodies, Antineutrophil Cytoplasmic , Cyclophosphamide/therapeutic use , Granulomatosis with Polyangiitis/diagnosis , Granulomatosis with Polyangiitis/drug therapy , Humans , Lymphocytes , Male , Microscopic Polyangiitis/drug therapy , Middle Aged , Recurrence , Retrospective Studies , Rituximab/therapeutic useABSTRACT
Objective Lumbar spinal stenosis (LSS) patients suffer from significant pain and disability. To assess long-term safety and efficacy of laminectomy in LSS patients, a systematic review and meta-analysis study was conducted. Methods Literature review in MEDLINE, Embase, Scopus, Web of Science, and Cochrane Library databases was performed using a predefined search strategy. Articles were included if they met the following characteristics: human studies, LSS, and at least 5 years of follow-up. Outcome measures included patient satisfaction, pain, disability, claudication, reoperation rates, and complications. Results Twelve articles met the eligibility criteria for our study. Overall, there was low-quality evidence that patients undergoing laminectomy, with at least 5 years of follow-up, have significantly more satisfaction, and less pain and disability, compared with the preoperative baseline. Assessment of neurogenic intermittent claudication showed significant improvement in walking abilities. We also reviewed the postoperative complication and adverse events in the included studies. After meta-analysis was performed, the reoperation rate was found to be 14% (95% confidence interval: 13-16%). Conclusion Our study provides low-quality evidence suggesting that patients undergoing laminectomy for LSS have less disability and pain and can be more physically active postoperatively.
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STUDY DESIGN: Systematic review. OBJECTIVES: This systematic review evaluates all randomized clinical trials (RCTs) conducted on assessing the efficacy and safety of pharmacologic therapies for the treatment of Spinal Cord Injury (SCI)-associated pain. METHODS: The PubMed/Medline, EMBASE, and Cochrane library online databases were searched from 1946 to May 2019 using specific search terms for SCI, pain, and RCTs meeting predetermined inclusion criteria. The efficacy outcome of interest was pain reduction, discontinuations, and adverse events (AEs). RESULTS: Of 2746 records identified through database searching, 703 duplicates were deleted. 1814 were excluded, the full text of the remaining 230 articles was reviewed, and finally, 28 papers were selected for drafting. The most studied medications were pregabalin, gabapentin, amitriptyline, and ketamine. Pregabalin, gabapentin, and amitriptyline reduced VAS by more than 30%, and ketamine reduced VAS by 40%. Oxcarbazepine, lamotrigine, alfentanil, tramadol, and morphine added to clonidine, baclofen, and botulinum toxin type A (BTA) significantly reduced pain compared with placebo. On the other hand, valproate, levetiracetam, trazodone, and duloxetine did not significantly alleviate SCI-associated pain compared to placebo. The risks of AEs and discontinuations in anticonvulsants were the least, while it was highest in analgesics. CONCLUSIONS: Studies of SCI-associated pain were few, small, heterogenic in measures and values, and did not allow quantitative comparisons of efficacy. However, available data suggested pregabalin and gabapentin led to a more marked reduction in SCI-associated pain with fewer AEs. Additional clinical studies are needed to assess the effect of established and novel management options.
Subject(s)
Ketamine , Spinal Cord Injuries , Amitriptyline/therapeutic use , Anticonvulsants , Gabapentin , Humans , Pain/drug therapy , Pain/etiology , Pregabalin/therapeutic use , Spinal Cord Injuries/complicationsABSTRACT
BACKGROUND: Proper utilization of high-quality clinical practice guidelines (CPGs) eliminates the dependence of patients' outcomes on the ability and knowledge of "individual" health care providers and reduces unwarranted variation in care. The aim of this study was to adapt/adopt two CPGs for pharmacologic management of acute spinal cord injury (SCI) using guideline adaptation methods. METHODS: This study was conducted based on the ADAPTE process. Following establishment of an organizing committee and choosing the health topics, we appraised the quality of the CPGs using the Appraisal of Clinical Guidelines for Research & Evaluation II (AGREE II). Then, the authors extracted and categorized suggestions according to Population, Intervention, Professions, Outcomes and Health care setting (PIPOH). The decision-making process was based on systemic evaluation of each suggestion, utilizing a combination of AGREE II scores, the quality of supporting evidence for or against each suggestion and the triad of feasibility, acceptance and adoptability for the Iranian health-care context. RESULTS: Two guidelines were included in the adaptation process. Based on high-quality of these guidelines and the feasibility and adoptability evaluation of the organizing committee, we decided to adopt the suggestion of both guidelines. Overall, seven suggestions were extracted from the source guidelines. CONCLUSION: This work provides a framework to apply guidelines for acute SCI to the developing regions of the world. Attempts should be made to implement these suggestions in order to improve the health outcomes of Iranian SCI patients.
Subject(s)
Spinal Cord Injuries , Humans , Iran , Spinal Cord Injuries/drug therapyABSTRACT
BACKGROUND: Individuals with moderate to severe traumatic brain injury (TBI) often have prolonged cognitive impairments, resulting in long-term problems with their real-life activities. Given the urgent need for evidence-based recommendations for neuropsychological management of Iranian TBI patients, the current work aimed to adapt eligible international guidelines for cognitive assessment and rehabilitation of the TBI patients in Iran. METHODS: The project was led by an executive committee, under the supervision of the Iranian Ministry of Health and Medical Education (MOHME). Following a systematic literature search and selection process, four guidelines were included for adaptation. Clinical recommendations of the source guidelines were tabulated as possible clinical scenarios for 90 PICO clinical questions covering all relevant phases of care. After summing up the scenarios, our initial list of recommendations was drafted according to the Iranian patients' conditions. The final decision-making, with the contribution of a national interdisciplinary panel of 37 experts from across the country, was conducted in two rounds using online and offline survey forms (Round 1), and face-to-face and telephone meetings (Round 2). RESULTS: A total of 63 recommendations in six sections were included in the final list of recommendations, among which 24 were considered as key recommendations. In addition, some of the recommendations were identified as fundamental, meaning that proper implementation of the other recommendations is largely dependent on their implementation. CONCLUSION: Iranian health policy makers and rehabilitation program managers are recommended to address some fundamental issues to provide the necessary infrastructure to set up an efficient cognitive rehabilitation service system.
Subject(s)
Brain Injuries, Traumatic/rehabilitation , Evidence-Based Medicine , Practice Guidelines as Topic , Humans , IranSubject(s)
Cyclophosphamide , Granulomatosis with Polyangiitis , Rituximab , Humans , Rituximab/therapeutic use , Cyclophosphamide/therapeutic use , Granulomatosis with Polyangiitis/drug therapy , Granulomatosis with Polyangiitis/diagnosis , Treatment Outcome , Female , Male , Middle Aged , Immunosuppressive Agents/therapeutic use , Remission Induction , Adult , Time Factors , Induction Chemotherapy , Aged , Retrospective StudiesABSTRACT
OBJECTIVEPredicting neurological recovery following traumatic spinal cord injury (TSCI) is a complex task considering the heterogeneous nature of injury and the inconsistency of individual studies. This study aims to summarize the current evidence on neurological recovery following TSCI by use of a meta-analytical approach, and to identify injury, treatment, and study variables with prognostic significance.METHODSA literature search in MEDLINE and EMBASE was performed, and studies reporting follow-up changes in American Spinal Injury Association (ASIA) Impairment Scale (AIS) or Frankel or ASIA motor score (AMS) scales were included in the meta-analysis. The proportion of patients with at least 1 grade of AIS/Frankel improvement, and point changes in AMS were calculated using random pooled effect analysis. The potential effect of severity, level and mechanism of injury, type of treatment, time and country of study, and follow-up duration were evaluated using meta-regression analysis.RESULTSA total of 114 studies were included, reporting AIS/Frankel changes in 19,913 patients and AMS changes in 6920 patients. Overall, the quality of evidence was poor. The AIS/Frankel conversion rate was 19.3% (95% CI 16.2-22.6) for patients with grade A, 73.8% (95% CI 69.0-78.4) for those with grade B, 87.3% (95% CI 77.9-94.8) for those with grade C, and 46.5% (95% CI 38.2-54.9) for those with grade D. Neurological recovery was significantly different between all grades of SCI severity in the following order: C > B > D > A. Level of injury was a significant predictor of recovery; recovery rates followed this pattern: lumbar > cervical and thoracolumbar > thoracic. Thoracic SCI and penetrating SCI were significantly more likely to result in complete injury. Penetrating TSCI had a significantly lower recovery rate compared to blunt injury (OR 0.76, 95% CI 0.62-0.92; p = 0.006). Recovery rate was positively correlated with longer follow-up duration (p = 0.001). Studies with follow-up durations of approximately 6 months or less reported significantly lower recovery rates for incomplete SCI compared to studies with long-term (3-5 years) follow-ups.CONCLUSIONSThe authors' meta-analysis provides an overall quantitative description of neurological outcomes associated with TSCI. Moreover, they demonstrated how neurological recovery after TSCI is significantly dependent on injury factors (i.e., severity, level, and mechanism of injury), but is not associated with type of treatment or country of origin. Based on these results, a minimum follow-up of 12 months is recommended for TSCI studies that include patients with neurologically incomplete injury.