Effectiveness of Applying Green Heart, a Smartphone-Based Self-management Intervention to Control Smoking: A Randomized Clinical Trial.

BACKGROUND: Cardiovascular diseases (CVDs) pose a significant global health concern and are the most common cause of death and disability, necessitating preventive interventions targeting modifiable risk factors. Recently, mobile-health technology has been developed to improve the delivery of cardiovascular prevention by risk factor modification. The "Green Heart" mobile application (app) was designed to aid in risk factor control among coronary artery disease (CAD) patients. METHODS: This parallel-group, single-blinded randomized controlled trial enrolled 1590 CAD patients, including 668 current smokers, randomly assigned to control (paper-based education) and intervention (application-based) groups. The app encompassed three modules targeting smoking cessation, dyslipidemia control, and blood pressure management. This study evaluated the impact of the smoking cessation module on behavioral change among current smokers. Green Heart assesses nicotine dependence, offering personalized quit plans, educational content, motivational messages, and automated progress tracking. The odds of smoking behavior changes during the 24-week follow-up underwent assessment. RESULTS: The intention-to-treat analysis highlighted significantly elevated rates of smoking cessation and reductions in the intervention group versus the control group. Adherence to the app (per-treatment analysis) also demonstrated significantly more favorable smoking behavior changes among the application users. Logistic regression emphasized higher odds of quitting and reduction in smoking in the application group, showing an odds ratio of 2.14 (95% CI: 1.16-3.97) compared to those not using the app (P=0.015). CONCLUSION: Our results confirmed that complete adherence to the app for at least 24 weeks was linked to alterations in cigarette smoking behavior among CAD patients. Trial Registration Number: IRCT20221016056204N1.

The effectiveness of green heart application to manage modifiable risk factors of coronary artery disease in Tehran Heart Center: Study protocol for a randomized controlled trial.

The burden of cardiovascular disease (CVD) is diminishing in developed countries. However, in middle- and low-income countries the CVD death rates are growing. CVD is the most common cause of death and disability in Iran and accounts for nearly half of all mortalities in Iranians. Therefore, preventive strategies by risk factor modification are a top priority in the country. Recently, Mobile-Health (mHealth) technology has been the focus of increasing interest in improving the delivery of cardiovascular prevention, targeting a combination of modifiable risk factors. This parallel-group single-blinded randomized controlled trial study has been designed to evaluate the impact of using a mHealth application on risk factors control. Individuals aged between 25 and 75 years who have documented CVD by coronary angiography in Tehran Heart Center and have at least one uncontrolled risk factor from the three including hypertension, dyslipidemia, and current cigarette smoking will be included. We are going to randomize 1544 patients into two study arms as follows: 1- Intervention: usual care + mHealth 2- Control: usual care + paper-based recommendations and educational materials. After 3 and 6 months of follow-up, the status of risk factors will be determined through outpatient visits and face-to-face interviews for both arms. Outcome: Successful risk factor control will be measured after 3 and 6 months. Nowadays, mHealth is becoming increasingly popular, providing a good opportunity for constant monitoring of risk factors and changing health behavior in a target population. Meanwhile, providing evidence for the effectiveness of health intervention delivery using mobile technologies could help health providers encourage their at-risk population to stop smoking, control blood pressure and blood cholesterol, and participate in regular physical activity. While the burden of CVD is growing in developing countries, this type of intervention can be a cost-effective way to reduce it in these countries.

Establishing research impact assessment in Iran: The first report from a non-high-income country.

Background: This study presents the first report on research impact assessment (RIA) in non-high-income countries, undertaken as a pilot initiative in 2021. Within it, we aimed to explore the feasibility of employing the 'payback' model for evaluating the impact of health research and enhancing the accountability of universities. We focussed on three key impact domains: 'production of decision support documents and knowledge-based products,' 'implementation of research results,' and 'health and economic impact.' Methods: We adopted a case study approach to assess the impact of 5334 health research projects conducted by researchers from 18 universities from 2018 to 2020. Researchers were required to submit evidence related to at least one of the specified impact domains; six scientific committees verified and scored claimed impacts at the national level. Results: Only 25% of the assessed projects achieved impact in at least one domain, with the production of decision support documents and knowledge products being the most reported impact. Notably, economic impact was verified in only three projects, indicating room for improvement in this area. Technology research exhibited the highest acceptance rate of claimed impact, suggesting a positive correlation between technology-focused projects and impactful outcomes. Conclusions: This study demonstrates the feasibility of employing a case study approach and the 'payback' model to evaluate the impact of health research, even within the constraints of a moderately equipped research infrastructure. These findings underscore the potential of integrating RIA into the governance of health research in Iran and other non-high-income countries, as well as the importance of using RIA to assess the accountability of health research systems, guide the allocation of research funding, and advocate for the advancement of health research. The study sets a precedent for future assessments in similar contexts and contributes to the ongoing global dialogue on the societal impact of health research.

Exploring nationwide policy interventions to control COVID-19 from the perspective of the rapid learning health system approach.

Introduction: The health systems needed to improve their learning capacities during the COVID-19 pandemic. Iran is one of the countries massively struck by the pandemic. This study aimed to explore whether and how the policy interventions made by Iran's policymakers at the national level to control COVID-19, could improve the rapid learning characteristics of the health system. Methods: A guide to clarify rapid learning health system (RLHS) characteristics was developed. The guide was used by two independent authors to select the policy interventions that could improve RLHS characteristics, then, to analyze the content of the selected policy interventions. In each stage, results were compared and discussed by all three authors. Final results were presented based on different RLHS characteristics and the potential mechanisms of contribution. Results: Five hundred policy interventions were developed during the first 7 months of the outbreak. Thirty-one policy interventions could potentially improve RLHS characteristics (6.2%). Two characteristics, such as the timely production of research evidence and the appropriate decision support were addressed by selected policy interventions. Policies, that could improve learning capacities, focused on decision-maker groups more than user groups or researcher groups. Conclusions: Most of the developed policy interventions during the first months of the epidemic did not address the learning capacities of the health system. To improve health system functions, improving RLHS characteristics of the health system, especially in patient-centered and data linkage characteristics, is recommended.

Exploring defensive medicine: examples, underlying and contextual factors, and potential strategies - a qualitative study.

BACKGROUND: Medical errors, unsatisfactory outcomes, or treatment complications often prompt patient complaints about healthcare providers. In response, physicians may adopt defensive practices to mitigate objections, avoid complaints, and navigate lengthy trial processes or other potential threats. However, such defensive medicine (DM) practices can carry risks, including potential harm to patients and the imposition of unnecessary costs on both patients and the healthcare system. Moreover, these practices may run counter to accepted ethical standards in medicine. METHODS: This qualitative study involved conducting semi-structured interviews with 43 physicians, among whom 38 were faculty members at medical universities, 42 had administrative experience at various levels of the health system, and 23 had previously served as health system policymakers. On average, the participants had approximately 23.5 years of clinical experience. The selection of participants was based on purposive sampling. Data collection through interviews continued until data saturation was achieved. RESULTS: Based on the findings, DM manifests in both positive and negative forms, illustrated by instances like ordering unnecessary lab tests, imaging, or consultations, reluctance to admit high-risk patients, and avoiding high-risk procedures. The study participants identified a range of underlying and contextual factors contributing to DM, encompassing organizational-managerial, social, personal, and factors inherent to the nature of defensive medical practices. The results also highlight proposed strategies to address and prevent DM, which can be grouped into organizational-managerial, social, and those focused on modifying the medical complaints management system. CONCLUSION: DM is a multifaceted and significant phenomenon that necessitates a comprehensive understanding of its various aspects, including interconnected and complex structures and underlying and contextual factors. While the results of this study offer a solid foundation for informing policy decisions within the healthcare system and include some explanatory policy suggestions, we encourage policymakers to complement the findings of this study with other available evidence to address any potential limitations and to gain a more comprehensive understanding of the policymaking process related to DM.

Complete Versus Incomplete Surgical Resection in Intramedullary Astrocytoma: Systematic Review with Individual Patient Data Meta-Analysis.

STUDY DESIGN: Systematic reviewBackground: Considering the infiltrative nature of intramedullary astrocytoma, the goal of surgery is to have a better patient related outcome. OBJECTIVE: To compare the overall survival (OS) and neurologic outcomes of complete vs incomplete surgical resection for patients with intramedullary astrocytoma. METHODS: A comprehensive search of MEDLINE, CENTRAL and EMBASE was conducted by two independent reviewers. Individual patient data (IPD) analysis and multivariate Cox Proportional Hazard Model was developed to measure the effect of surgical strategies on OS, post-operative neurological improvement (PNI), and neurological improvement in the last follow up (FNI). RESULTS: We included 1079 patients from 35 studies. Individual patient data of 228 patients (13 articles) was incorporated into the integrative IPD analysis. Kaplan-Meier survival analysis showed complete resection (CR) significantly improved OS in comparison with the incomplete resection (IR) (log-rank test, P = .004). In the multivariate IPD analysis, three prognostic factors had significant effect on the OS: (1) Extent of Resection, (2) pathology grade, and (3) adjuvant therapy. We observed an upward trend in the popularity of chemotherapy, but CR, IR, and radiotherapy had relatively stable trends during three decades. CONCLUSION: Our study shows that CR can improve OS when compared to IR. Patients with spinal cord astrocytoma undergoing CR had similar PNI and FNI compared to IR. Therefore, CR should be the primary goal of surgery, but intraoperative decisions on the extent of resection should be relied on to prevent neurologic adverse events. Due to significant effect of adjuvant therapy on OS, PNI and FNI, it could be considered as the routine treatment strategy for spinal cord astrocytoma.

Respecting patients' rights in hospitals: patients' and health-care workers' perspectives.

Considering the importance of respecting and observing patients' rights, this study aimed to assess the level of observance of hospitalized patients' rights from both patients' and health-care workers' (HCWs) perspectives. This cross-sectional descriptive-analytic study reports the responses of 486 patients and 887 HCWs in a public referral university hospital. The study illustrates that patients and HCWs think patients' rights are respected at a medium level; however, HCWs reported lower levels of respect for patients' rights than patients, and senior HCWs reported even lower levels than their younger colleagues. Older patients and those hospitalized in internal medicine wards reported lower respect for autonomy and responsiveness, and patients' companions reported lower levels of respect for patients' rights than the patients themselves.

Development and validation of an online tool for assessment of health care providers' management of suspected malaria in an area, where transmission has been interrupted.

BACKGROUND: The alertness and practice of health care providers (HCPs) in the correct management of suspected malaria (CMSM) (vigilance) is a central component of malaria surveillance following elimination, and it must be established before malaria elimination certification can be granted. This study was designed to develop and validate a rapid tool, Simulated Malaria Online Tool (SMOT), to evaluate HCPs' practice in relation to the CMSM. METHODS: The study was conducted in East Azerbaijan Province, Islamic Republic of Iran, where no malaria transmission has been reported since 2005. An online tool presenting a suspected malaria case for detection of HCPs' failures in recognition, diagnosis, treatment and reporting was developed based on literature review and expert opinion. A total of 360 HCPs were allocated to two groups. In one group their performance was tested by simulated patient (SP) methodology as gold standard, and one month later by the online tool to allow assessment of its sensitivity. In the other group, they were tested only by the online tool to allow assessment of any possible bias incurred by the exposure to SPs before the tool. RESULTS: The sensitivity of the tool was (98.7%; CI 93.6-99.3). The overall agreement and kappa statistics were 96.6% and 85.6%, respectively. In the group tested by both methods, the failure proportion by SP was 86.1% (CI 80.1-90.8) and by tool 87.2% (CI 81.4-91.7). In the other group, the tool found 85.6% (CI 79.5-90.3) failures. There were no significant differences in detecting failures within or between the groups. CONCLUSION: The SMOT tool not only showed high validity for detecting HCPs' failures in relation to CMSM, but it had high rates of agreement with the real-world situation, where malaria transmission has been interrupted. The tool can be used by program managers to evaluate HCPs' performance and identify sub-groups, whose malaria vigilance should be strengthened. It could also contribute to the evidence base for certification of malaria elimination, and to strengthening prevention of re-establishment of malaria transmission.

Incidence of symptomatic COVID-19 in close contacts of patients after discharge from hospital.

BACKGROUND: There is a little evidence about the infectiousness of recovered COVID-19 patients. Considering that the circumstance of the isolation of the COVID-19 patients after-discharge is not always optimal, it is not very unlikely that viral transmission still occurs after hospital discharge. This study aims to investigate the incidence of symptomatic COVID-19 in close contacts of recovered patients after discharge from hospital. METHODS: Four hundred fifty discharged COVID-19 patients discharged from the largest public treatment center in Tehran, capital city of Iran, were followed up. Demographic and clinical data of participants were collected from medical records. Follow-up data were acquired via telephone call interviews with patients or their main caregivers at home. RESULTS: The study's response rate was 93.77% (422 participated in the study). 60.90% patients were male and 39.10% were female (sex ratio = 1.55 male). The most prevalent comorbidities in these patients were hypertension (29.68%) and diabetes (24.80%). The mean of home isolation after discharge was 25.85. Forty-one (9.71%) patients had at least one new case in their close contacts, up to 3 weeks after they were discharged. There was a significant association between having at least a comorbidity with the odds of getting infected in close contacts [OR (CI) 2.22 (1.05-4.68)]. Density of inhabitant per room in a house' and the quality of isolation had significant associations with observing new cases in the patients' close contacts [high to moderate; OR (CI) 2.44 (1.06-5.61], [bad to good; OR (CI) 2.31 (1.17-4.59)], respectively. CONCLUSION: After hospital discharge, COVID-19 transmission can still occur, when a large number of people lives together in a single house. Another explanation can be that the less precaution measures are taken by recovered patients' cohabitants. Such conditions are also likely to happen when the recovered patient has other chronic diseases and requires additional care.

PROTOCOL: Systematic review of methods to reduce risk of bias in knowledge translation interventional studies in health-related issues.

Background: Review studies have reported on the low quality of study methodologies and poor reporting of knowledge translation (KT) interventional studies. This flaw cause the result of such studies to become misleading. Objectives: The present review is designed to evaluate the effect of methodological factors on the results of interventional studies that aimed to evaluate KT strategies at the policy level. Search Methods: Bibliographic databases and grey literature databases will be searched. The retrieved studies will be recorded in Covidence. After screening titles and abstracts, the full texts of selected studies will be assessed against the inclusion criteria. Disagreements will be resolved through discussion or by consultation with a third author. Selection Criteria: Primary studies are studies that aimed to estimate the efficacy of KT strategies to improve evidence-informed policymaking. Study participants include policymakers and the intervention is a KT strategy. The main outcome is the desired changes in policy-makers towards evidence-informed decision-making. Data Collection and Analysis: The main effect sizes will be expressed as standard mean difference and its variance for the main efficacy outcome of KT strategies in primary studies. Forest plot meta-analysis will be used to synthesize the effect of each group of KT strategies. The contribution of ROB to the efficacy of KT interventions will be assessed via Meta-epidemiology analysis. The overall estimate will be calculated using inverse-variance random-effects meta-analysis with a 95% confidence interval for the estimate.

The Effects of Helicobacter Pylori Eradication on Liver Function and Metabolic Profile in Non-diabetic Non-alcoholic Steatohepatitis: A 5-year Randomized Clinical Trial.

BACKGROUND: To evaluate the effects of Helicobacter pylori (HP) eradication on liver function tests (LFT) and fat content (LFC) in non-diabetic non-alcoholic steatohepatitis (NASH). METHODS: This randomized clinical trial included dyspeptic HP infected non-diabetic NASH participants. The intervention arm received HP eradication treatment, while the control arm did not get any HP treatment. In the meantime, the standard management of NASH was performed in both trial arms. Mean alterations in LFT were the primary outcome and the secondary outcomes included the mean changes in LFC and serum metabolic profile. The trial follow-up period was 5 years. RESULTS: 40 participants (female: 20), with a mean age of 41.58 (±12.31) years, were enrolled in the study. The HP eradication arm included 20 participants (female: 11) with a mean age of 40.25 (±10.59) years, and the control arm consisted of 20 individuals (female: 9) with a mean age of 42.90 (±13.97) years. The tests of within-subjects effects showed a significant decrease in mean serum alanine aminotransferase (ALT; P=0.007), triglyceride (TG; P=0.04), cholesterol (P=0.004), and fasting blood sugar (FBS; P<0.001), and an increase in high-density lipoprotein (HDL; P=0.04) in both research groups during the study period. The tests of between-subjects effects demonstrated a more significant decrement of FBS in HP eradicated patients than the controls (P=0.02). The reduction in waist circumference, aspartate aminotransferase (AST), ALT, alkaline phosphatase, triglyceride, cholesterol, low-density lipoprotein, insulin, and LFC were more prominent in the intervention group than the controls; however, these differences were not statistically significant. CONCLUSION: Adding HP eradication treatment to standard NASH treatment showed more therapeutic effect thanthe standard NASH treatment protocol alone regarding the decrement of FBS in participants with dyspeptic non-diabetic NASH. Considering the non-statistically significant improvement in other metabolic indices and LFT in this trial, further studies are recommended.

Comparison of Intraoperative Infusion of Remifentanil Versus Fentanyl on Pain Management in Patients Undergoing Spine Surgery: A Double Blinded Randomized Clinical Trial.

BACKGROUND: Remifentanil is an ultra-short-acting opioid which facilitates hemodynamic management. However, there are concerns about postoperative Remifentanil hyperalgesia because of its potent fast onset and offset. OBJECTIVES: The aim of this study was to determine visual analog scale (VAS), postoperative pain, and morphine used in two groups after spine surgery. METHODS: In this randomized clinical trial study, 60 patients aged 18 - 60 years old, according to the American Society of Anesthesiology (ASA) I - II, who underwent spinal canal stenosis or scoliosis surgery, were divided into two groups. In the control group, patients received 0.07 - 0.1 µg/kg/h intraoperative Fentanyl infusion, and in the intervention group 0.1 - 0.2 µg/kg/min remifentanil was infused during the surgery. Both groups received 15 mg/kg intravenous Acetaminophen 20 minutes before the end of the surgery. Postoperative pain score and morphine consumption were measured 6, 12, 24, and 48 hours after discharge from the post-anesthesia care unit (PACU). RESULTS: During the first 12 hours, VAS and morphine consumption were significantly higher in remifentanil group (P < 0.001). However, no significant difference was found between the two groups in morphine consumption 12 - 48 hours after surgery. CONCLUSIONS: These findings suggest that Remifentanil infusion during surgery may increase postoperative pain. Also, VAS and morphine consumption were higher during the first 12 hours.

Health workers readiness and practice in malaria case detection and appropriate treatment: a meta-analysis and meta-regression.

BACKGROUND: Health workers (HWs) appropriate malaria case management includes early detection and prompt treatment with appropriate anti-malarial drugs. Subsequently, HWs readiness and practice are considered authentic evidence to measure the health system performance regarding malaria control programme milestones and to issue malaria elimination certification. There is no comprehensive evidence based on meta-analysis, to measure the performance of HWs in case management of malaria. This study aimed to evaluate HWs performance in early malaria case detection (testing) and the appropriate treatment. METHODS: The published literature in English was systematically searched from Medline, Scopus, Embase, and Malaria Journal up to 30th December 2020. The inclusion criteria were any studies that assessed HWs practice in early case detection by malaria testing and appropriate treatment. Eligibility assessment of records was performed independently in a blinded, standardized way by two reviewers. Pooled prevalence estimates were stratified by HWs cadre type. Meta-regression analysis was performed to explore the impact of the appropriateness of the method and risk of bias as potential sources of the heterogeneity in the presence of effective factors. RESULTS: The study pooled data of 9245 HWs obtained from 15 included studies. No study has been found in eliminating settings. The pooled estimate for appropriate malaria treatment and malaria testing were 60%; 95% CI: 53-67% and 57%; 95% CI: 49-65%, respectively. In the final multivariable meta-regression, HWs cadre and numbers, appropriateness of study methods, malaria morbidity and mortality, total admissions of malaria suspected cases, gross domestic product, availability of anti-malarial drugs, and year of the publication were explained 85 and 83% of the total variance between studies and potential sources of the heterogeneity for malaria testing and treating, respectively. CONCLUSION: HWs adherence to appropriate malaria case management guidelines were generally low while no study has been found in eliminating countries. Studies with the inappropriateness methods and risk of bias could be overestimating the actual proportion of malaria appropriate testing and treating. Strategies that focus on improving readiness and early identification of acute febrile diseases especially in the countries that progress to malaria elimination should be highly promoted.

Preventing and controlling water pipe smoking: a systematic review of management interventions.

BACKGROUND: Water pipe smoking (WPS) is re-gaining widespread use and popularity among various groups of people, especially adolescents. Despite different adverse health effects of WPS, many of the WPS interventions have failed to control this type of tobacco smoking. This study was conducted to identify experienced management interventions in preventing and controlling WPS worldwide. METHODS: A systematic literature review was conducted. Electronic databases were searched for recordes which were published from beginning 1990 to August 2018. Studies aiming at evaluating, at least, one intervention in preventing and controlling WPS were included in this review, followed by performing the quality assessment and data extraction of eligible studies by two independent investigators. Finally, interventions that were identified from the content analysis process were discussed and classified into relevant categories. RESULTS: After deleting duplications, 2228 out of 4343 retrieved records remained and 38 studies were selected as the main corpus of the present study. Then, the identified 27 interventions were grouped into four main categories including preventive (5, 18.51%) and control (8, 29.62%) interventions, as well as the enactment and implementation of legislations and policies for controlling WPS at national (7, 25.92%) and international (7, 25.92%) levels. CONCLUSION: The current enforced legislations for preventing and controlling WPS are not supported by rigorous evidence. Informed school-based interventions, especially among adolescents can lead to promising results in preventing and controlling WPS and decreasing the effects of this important social and health crisis in the global arena.

Living versus deceased kidney transplantation: Comparison of complications.

INTRODUCTION: It is assumed that the outcome of kidney transplantation from living donors is more favorable than deceased donors. However, over the years there has been an overall improvement in transplant survival from both living and deceased donors. In this article we have evaluated and compared the most recent results in living and deceased donor kidney transplantations. PATIENTS AND METHODS: Four hundred and forty six patients underwent kidney transplantation in our center from September 2009 to March 2014. The patients divided in two groups living (group A) and deceased (group B) donor transplantation groups. The patients were followed until September 2016. Acute rejection, graft survival, delayed graft function, renal artery thrombosis, graft nephrectomy, ureterocutaneous fistula, postoperative hypertension, mortality, hospital stay, hyperlipidemia, post transplantation diabetes and lymphocele rate measured and compared in two groups. RESULTS: Most variables were not different between the two groups except lymphocele and delayed graft function. Lymphocele was more prevalent in group A (13.8% vs 3.1%, p-value = 0.02) and delayed graft function results were more desirable in living donor transplantation group (group B). CONCLUSION: Although, delayed graft function was less common in transplantation from living donors, short, and long term graft survival was not significantly different in this study.

Evaluation of the Preventive Effects of Carvedilol on Trastuzumab-Induced Cardiotoxicity in Early-Stage and Locally Advanced HER2-Positive Breast Cancer Patients.

Background: Trastuzumab is an efficient monoclonal antibody used in the treatment of Her2-positive breast cancer. Despite its prominent effect on Her2-positive patients' disease-free Survival. Trastuzumab-induced cardiotoxicity is still one of the main challenges. Angiotensin-converting enzyme inhibitors (ACE inhibitors) are one of the most potent agents used in heart failure, which also showed confirmed cardioprotective effects against anthracycline and doxorubicin. We aimed to assess the cardioprotective effects of Carvedilol in a randomized clinical trial study. Materials and Methods: sixty non-metastatic Her-2 positive patients (30 cases; 30 controls) were entered into the study via a simple randomization method.Carvedilol was administered for the patients with the starting dose of 3.125 mg twice a day and started 7 days before trastuzumab administration. The dose has been increased in a three-week period to reach 12.5 mg twice a day and continued until the end of therapy. All the patients underwent an echocardiography after receiving Adriamycin and Cyclophosphamide in order to measure basal Ejection Fraction (EF) and Pulmonary Artery Pressure (PAP). Each patient underwent a follow-up echocardiography in 3,6,9 and 12 months after initiation of the treatment. Finally, all the patients went through the last episode of echocardiography 1 month after the end of treatment. All the Measured PAP and EF has been recorded and analyzed Results: EF and PAP changes for both groups had no significant changes during the course of treatment with Trastuzmab (p-value = 0.628 and p-value = 0.723, respectively). Seven patients in the intervention group and 2 patients in the control group presented with EF decrease. Also, 8 patients in the intervention and 9 patients in the control groups showed PAP increase. Conclusion: According to our results, in patients with HER2-positive breast cancer treated with trastuzumab, Carvedilol showed no significant protective effect on trastuzumab-induced cardiotoxicity.

Complete Versus Incomplete Surgical Resection in Intramedullary Ependymomas: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review. OBJECTIVE: To compare outcomes of complete versus incomplete resection in primary intramedullary spinal cord ependymoma. METHODS: A comprehensive search of the MEDLINE, CENTRAL, and Embase databases was conducted by 2 independent investigators. Random-effect meta-analysis and meta-regression with seven covariates were performed to evaluate the reason for the heterogeneity among studies. We also used individual patient data in the integrative analysis to compare complete and incomplete resection based on 4 outcomes: progression-free survival (PFS), overall survival (OS), postoperative neurological improvement (PNI), and follow-up neurological improvement (FNI). RESULTS: A total of 23 studies were identified, including 407 cases. Significant heterogeneity among included studies was observed in risk estimates (I2 for PFS, FNI, and PNI were 49.5%, 78.3%, and 87.2%, respectively). The mean follow-up time across cases was 48.6 ± 2.35 months. Cox proportional multivariable analysis revealed that the complete resection can prolong PFS (model, hazard ratio = 0.18, CI 0.05-0.54, P = .004,) and improve the FNI (binary logistic regression, adjusted odds ratio = 16.5, CI 1.6-171, P = .019). However, PNI and OS were similar in patients with incomplete resected spinal cord ependymoma compared with complete resection (binary logistic regression respectively and Cox multivariable analysis, P > .5). CONCLUSION: The data presented in this study showed that OS was not significantly affected by the degree of surgery. However, complete resection of intramedullary ependymomas provides the optimal outcomes with longer PFS and better long-term neurological outcomes than incomplete resection.

Comparison of intravenous ketorolac at three doses for treating renal colic in the emergency department: A noninferiority randomized controlled trial.

BACKGROUND: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that is extensively used for the management of renal colic in the emergency department (ED). It has been proposed that ketorolac is used at doses above its analgesic ceiling with no more advantages and increased risk of adverse effects. In this study, we compared the analgesic effects of three doses of intravenous ketorolac in patients with renal colic. METHODS: This noninferiority, randomized, double-blind clinical trial evaluated the analgesic efficacy of three doses of intravenous ketorolac (10, 20, and 30 mg) in adult patients presenting to the ED with renal colic. Exclusion criteria consisted of age > 65 years, active peptic ulcer disease, acute gastrointestinal hemorrhage, renal or hepatic insufficiency, NSAID hypersensitivity, pregnancy or breastfeeding, unstable vital signs, and patients who had received analgesics in the past 24 hours. Pain was recorded every 15 minutes from baseline up to 60 minutes, and the primary outcome was pain reduction at 30 minutes. If patients still required additional pain medications at 30 minutes, they would receive 0.1 mg/kg intravenous morphine sulfate as a rescue analgesic. RESULTS: A total of 165 subjects enrolled in this study, 55 in each group. The median visual analog scale score in 30 minutes was improved from 90 at baseline to 40 among subjects who were randomized to 30-mg group. This improvement was 40 and 50 mm in 20- and 10-mg ketorolac treatment arms, respectively, with no significant difference between the three doses (p < 0.05). Secondary outcomes showed similar rescue analgesic administration and adverse effects. There was no serious adverse event. CONCLUSION: Ketorolac at 10-, 20-, and 30-mg doses can produce similar analgesic efficacy in renal colic.