Translation, cross-cultural adaptation and validation of the Persian version of selected PROMIS measures for use in lumbar canal stenosis patients.

BACKGROUND: The National Institutes of Health (NIH) developed a new measurement system called the Patient-Reported Outcomes Measurement Information System (PROMIS) which can be used for multiple health conditions. The 29-item short form (PROMIS-29) with seven domains was more often used by clinical researchers to measure the physical function, mood and sleeping status of patients with low back pain (LBP). Translation of the PROMIS into multiple languages and adaptation of its application in different cultural diversities can help to further standardize clinical research studies and make them comparable to each other. This study aimed to cross-culturally adapt the PROMIS-29 into Persian (P-PROMIS-29) and evaluate the construct validity and reliability of the translated questionnaire among patients with lumbar canal stenosis. MATERIALS AND METHODS: The translation was conducted by using the multilingual translation methodology guideline. Construct validity, internal consistency, and test-retest reliability at a two-week interval for the P-PROMIS-29 were calculated. Construct validity was assessed by calculating correlations between the P-PROMIS-29 with Oswestry Disability Index (ODI) and Roland-Morris results. RESULTS: The study sample included 70 participants with lumbar canal stenosis. Internal consistencies were moderate to good with Cronbach's alpha ranging from 0.2 to 0.94. The test-retest reliability evaluation was excellent with intraclass correlation coefficients (ICCs) ranging from 0.885 to 0.986. Construct validity of different domains of P-PROMIS-29 were moderate to good, with Pearson's correlation coefficient results ranging from 0.223 to 0.749. CONCLUSION: Our results showed that P-PROMIS-29 is a valid and reliable measurement tool for evaluation of patients with lumbar canal stenosis.

Effect of Topical Administration of Tranexamic Acid on Intraoperative and Postoperative Blood Loss during Posterior Cervical Laminectomy and Fusion Surgery: A Retrospective Study.

AIM: To assess the role of topical administration of tranexamic acid (TXA) on intraoperative and postoperative blood loss of patients undergoing posterior cervical laminectomy and lateral mass screw ?xation (PCLF) compared to a control group. MATERIAL AND METHODS: The data of 88 patients that underwent PCLF surgery, including 41 females and 47 males, were included in this retrospective study. Data elements including intraoperative blood loss (IBL), postoperative blood loss (PBL), amount of blood transfusion, surgical time, use of hemostatic agents, length of hospital stay, and time to return to work were extracted from medical records and compared between those who received topical TXA during surgery (irrigation of the surgical field with a solution of 3 g TXA in 100 ml normal saline) and an age- and sex-matched control group. RESULTS: There were 48 patients in the TXA group and 40 patients in the control group. There were no significant differences in the baseline measurements and the level of operation between the two groups. The results showed that IBL and PBL were significantly lower in the TXA group compared to the control group (p=0.03 and p < 0.01, respectively). There were no significant differences in the need for blood transfusion, surgical time, and hospital stay between the two groups (p > 0.05). Moreover, the use of hemostatic materials during surgery and the time to return to work were significantly lower in the topical TXA group (p=0.04 and p < 0.01, respectively). CONCLUSION: Topical TXA efficiently reduces intraoperative and postoperative bleeding in patients undergoing posterior cervical laminectomy and PCLF surgery. These results need further investigation in future studies to draw a definite conclusion.

The Effect of L-Carnitine on Mortality Rate in Septic Patients: A Systematic Review and Meta-Analysis on Randomized Clinical Trials.

BACKGROUND: Recent clinical trial studies have reported that L-carnitine supplementation can reduce the mortality rate in patients with sepsis, but there are no definitive results in this context. The current systematic review and meta-analysis aimed to evaluate the effect of L-carnitine supplementation on 28-day and one-year mortality in septic patients. METHODS: A systematic search conducted on Pubmed, Scopus and Cochrane Library databases up to June 2019 without any language restriction. The publications were reviewed based on the Cochrane handbook and preferred reporting items for systematic reviews and meta-analyses (PRISMA). To compare the effects of L-carnitine with placebo, Risk Ratio (RR) with 95% confidence intervals (CI) were pooled according to the random effects model. RESULTS: Across five enrolled clinical trials, we found that L-carnitine supplementation reduce one-year mortality in septic patients with SOFA> 12 (RR: 0.68; 95% CI: 0.49 to 0.96; P= 0.03) but had no significant effect on reducing 28-day mortality ((RR: 0.93; 95% CI: 0.68 to 1.28; P= 0.65) compared to placebo. Finally, we observed that based on current trials, L-carnitine supplementation may not have clinically a significant effect on mortality rate. CONCLUSION: L-carnitine patients with higher SOFA score can reduce the mortality rate. However, the number of trials, study duration and using a dosage of L-carnitine are limited in this context and further large prospective trials are required to clarify the effect of L-carnitine on mortality rate in septic patients.

Current Understanding and Unknown Aspects of the Treatment of Granulomatosis with Polyangiitis (Wegener's Granulomatosis): Opportunities for Future Studies.

Granulomatosis with polyangiitis (GPA) is a rare and systemic autoimmune disease, causing necrotizing vasculitis of small arteries and veins. The majority of diagnosed patients with GPA have circulating anti-neutrophil cytoplasmic antibodies (ANCA) directed against proteinase 3 (PR3). Here, we have reviewed the last findings and uncertainties regarding the treatment of GPA. Between the available treatments, in addition to corticosteroids, cyclophosphamide (CYP) is effective for remission-induction, while it is associated with some serious side effects, such as infertility and increased risk of malignancies. On the other side, rituximab (RTX) seems a safer alternative option and as effective as CYP. It could be used as both remission-induction and maintenance therapy in GPA patients, especially in women of childbearing age. Pregnant patients, who must not be exposed to the CYP and RTX could be well-managed with intravenous immunoglobulin (IVIg). Co-trimoxazole, which is widely used to treat certain bacterial infections or as prophylaxis in immunosuppressed patients, could be effective in preventing disease relapse. In the meantime, 15- deoxyspergualin, plasma exchange are other therapeutic options with a low level of evidence. Regarding potential treatments, ofatumumab, ocrelizumab, belimumab, atacicept, tabalumab, abatacept (CTLA4-Ig), and Janus kinase inhibitors seem to be effective. Renal involvement, older age, the presence of baseline organ damage, delayed-diagnosis of disease, rising in creatinine level, and higher neutrophil/lymphocyte ratio is associated with poor outcomes. Optimum doses of medications, prediction of treatment response and disease relapse, explaining lack of response in some patients, treating children with GPA, and management of GPA during the pregnancy are controversial issues, which need further studies.

A comprehensive review of rituximab therapy in rheumatoid arthritis patients.

Rituximab (RTX) is an approved treatment for rheumatoid arthritis (RA) patients that do not respond adequately to disease-modifying antirheumatic drugs. However, different new concerns, such as efficacy, optimum dose, safety issues, prediction of response to RTX, and pregnancy outcomes have attracted a lot of attention. The PubMed database was systematically reviewed for the last published articles, new findings, and controversial issues regarding RTX therapy in RA using "Rheumatoid arthritis" AND "rituximab" keywords, last updated on June 18, 2019. From 1812 initial recorders, 162 studies met the criteria. Regarding the optimum dose, low-dose RTX therapy (2 × 500 mg) seems as effective as standard dose (2 × 1000 mg), safer, and more cost-effective. The most common reported safety challenges included de novo infections, false negative serologic tests of viral infections, reactivation of chronic infections, interfering with vaccination outcome, and development of de novo psoriasis. Other less reported side effects are infusion reactions, nervous system disorders, and gastrointestinal disorders. Lower exposure to other biologics, presence of some serological markers (e.g., anti-RF, anti-CCP, IL-33, ESR), specific variations in FCGR3A, FCGR2A, TGFß1, IL6, IRF5, BAFF genes, and also EBV-positivity could be used to predict response to RTX. Although there is no evidence of the teratogenic effect of RTX, it is recommended that women do not expose themselves to RTX at least 6 months before the conception. Only a reversible reduction of B cell-count in the offspring may be the pregnancy-related outcome. Although RTX is an effective therapeutic option for RA, more studies on optimum doses, prevention of RTX-related side effects, prediction of RTX response, and safety during the pregnancy are required.

Effect of orthopedic surgery delay and counseling on postoperative complications and mortality rate in patients aged over 55 years in a teaching hospital.

AIM: The purpose of this study was to investigate the effects of delay in the operation and counseling on postoperative complications and mortality rates in elderly patients. METHODOLOGY: The present study was a descriptive cross-sectional research. Population of this study was the entire elderly hospitalized patients who aged over 55 years for emergency orthopedic surgeries in a teaching hospital in Tehran. Surgery delays were then determined after examining the checklists, and the relationship between the variables and surgery delays, number of preoperative counseling, complications, and mortality rate was evaluated. Data were analyzed using the Mann-Whitney U-test and Pearson correlation coefficient in SPSS 18 at a 0.05 significance level. RESULTS: Overall, 89.9% of the patients had counseling. The average hospitalization days were 5 days until surgery, and the standard deviation was 0.50. The mean counseling number was 5.5. The relationship between number of counseling and surgical delays was significant. Delay in surgery in this age group, mortality, and the chances of death have become 2.7 times more than who had not a surgical delay. No significant relationship was observed between surgery delay and the incidence of Deep Venous Thrombosis (P = 0.102), postoperative sepsis and Myocardial Infarction (P = 0.337), embolism (P = 0.505), and postoperative Cerebrovascular Accident (P = 0.153). CONCLUSIONS: The delay in surgery in the elderly causes an increase in mortality. Considering the findings of this study and the importance of emergency orthopedic surgeries in the elderly, to reduce the surgical delays and the mortality rate in the elderly, the establishment of a surgical team for elderly patients in hospitals is recommended.

The Neuromodulatory Effects of ω-3 Fatty Acids and Nano-Curcumin on the COX-2/ iNOS Network in Migraines: A Clinical Trial Study from Gene Expression to Clinical Symptoms.

BACKGROUND: Migraine is a common neuroinflammatory disorder characterized by recurrent attacks of pain. Human and experimental models of migraine studies have demonstrated the role played by COX-2/ iNOS in migraine's neuroinflammatory pathogenesis. COX-2 and iNOS are closely linked and both contribute to inflammation and neurogenic pain in the central nervous system. Omega- 3 fatty acids and curcumin, an active polyphenol of turmeric, have anti-inflammatory and neuroprotective effects through several mechanisms, including the suppression of COX-2 and iNOS gene expression, as well as their serum levels. The aim of the present study is to evaluate the nutrigenomic effects of ω-3 fatty acids, nano-curcumin, and a combination of the two, on neuroinflammation and clinical symptoms in migraine patients. METHODS: This study reports the results of a clinical trial over a 2-month period, involving 74 episodic migraine patients who received ω-3 fatty acids, nano-curcumin, a combination of them, or a placebo. At the start and end of the study, the expression of COX-2/iNOS (in peripheral mononuclear blood cells isolated from patients) and COX-2/iNOS serum levels were measured, using real-time PCR and ELISA respectively. The frequency, severity and duration of pain attacks were also recorded. RESULTS: The results of the present trial showed that ω-3 fatty acids and nano-curcumin can reinforce each other's effects in the downregulation of COX-2/iNOS mRNA, as well as reduce their serum levels. In addition, the combination of ω-3 and nano-curcumin significantly reduced the frequency, severity and duration of headaches (P<0.05). CONCLUSION: These findings indicate that combination therapy of ω-3 fatty acids and nano-curcumin can be considered as a promising new approach in migraine prevention.

A Novel Combination of ω-3 Fatty Acids and Nano-Curcumin Modulates Interleukin-6 Gene Expression and High Sensitivity C-reactive Protein Serum Levels in Patients with Migraine: A Randomized Clinical Trial Study.

BACKGROUND: Migraine is a disabling neuroinflammatory condition characterized by increasing the levels of interleukin (IL)-6, a proinflammatory cytokine and C-reactive protein (CRP) which considered as a vascular inflammatory mediator, disrupting the integrity of blood-brain barrier and contributing to neurogenic inflammation, and disease progression. Curcumin and ω-3 fatty acids can exert neuroprotective effects through modulation of IL-6 gene expression and CRP levels. The aim of present study is the evaluation of combined effects of ω-3 fatty acids and nano-curcumin supplementation on IL-6 gene expression and serum level and hs-CRP levels in migraine patients. METHODS: Eighty episodic migraine patients enrolled in the trial and were divided into four groups as 1) combination of ω-3 fatty acids (2500 mg) plus nano-curcumin (80 mg), 2) ω-3 (2500 mg), 3) nanocurcumin (80 mg), and 4) the control (ω-3 and nano-curcumin placebo included oral paraffin oil) over a two-month period. At the beginning and the end of the study, the expression of IL-6 from peripheral blood mononuclear cells and IL-6 and hs-CRP serum levels were measured, using a real-time PCR and ELISA methods, respectively. RESULTS: The results showed that both of ω-3 and nano-curcumin down-regulated IL-6 mRAN and significantly decreased the serum concentration. hs-CRP serum levels significantly decrease in combination and nano-curcumin within groups (P<0.05). An additive greater reduction of IL-6 and hs-CRP was observed in the combination group suggested a possible synergetic relation. CONCLUSION: It seems that ω-3 fatty acids and curcumin supplementation can be considered a new promising target in migraine prevention.

Comparison of metformin and insulin in the control of hyperglycaemia in non-diabetic critically ill patients.

INTRODUCTION: It is accepted that preventing hyperglycaemia during critical illness while assuring adequate caloric intake can reduce mortality and morbidity. The aim of this study was to compare the metabolic effects of metformin and insulin on hyperglycaemia in ICU patients. METHODS: This double-blind randomised clinical trial was performed on 24 patients who were admitted to the intensive care unit (ICU) from 20 March to 20 September 2007. All patients with serious injuries or with major non-abdominal surgeries were included if they met the inclusion criteria, and were assigned randomly to one of the study groups. Patients in Group 1 received intensive insulin therapy, and patients in Group 2 were treated with metformin. Moreover, the Acute Physiology And Chronic Health Evaluation (APACHE) II scoring system was used to grade disease severity. RESULTS: Both glycaemic management protocols led to significantly improved glucose levels without any report of hypoglycaemia. The mean initial glucose levels for the insulin group decreased significantly after the intravenous infusion of insulin (p < 0.001). Additionally, the blood glucose concentration was significantly lower after two weeks of metformin administration compared to baseline measurements (p < 0.001). Moreover, the blood glucose concentration decrease during these two weeks was significantly higher in the insulin group (p = 0.01). Besides, APACHE II score was lower than baseline at the end of the study for both therapeutic groups (score of 10 vs. 15 [insulin] and 16 [metformin]). Finally, new renal dysfunction (maximum serum creatinine level at least double the initial value) was observed in three of the patients (two patients from the metformin group and one from the insulin group) in the last days of the protocol, although none of the patients showed lactic acidosis after ICU admission. CONCLUSIONS: Both metformin and intensive insulin therapy significantly decreased hyperglycaemia in ICU patients. Insulin caused a greater reduction in blood glucose concentration but required more attention and trained personnel.