Assessment of confidence in medical writing: Development and validation of the first trustworthy measurement tool.

BACKGROUND: The popularity of medical writing workshops highlights the need for a standard measurement tool to assess the impact of such workshops on participants' confidence in: 1- writing a standard article and 2- using optimal English language. Because such an instrument is not yet available, we undertook this study to devise and evaluate the first measurement tool to assess such confidence. METHOD: We created an item pool of 50 items by searching Medline, Embase, and Clarivate Analytics to find related articles, using our prior experience, and approaching the key informants. We revised and edited the item pool, and redundant ones were excluded. Finally, the 36-item tool comprised two domains. We tested it in a group of workshop applicants for internal consistency and temporal reliability using Cronbach's α and Pearson correlations and for content and convergent validity using the content validity index and Pearson correlations. RESULTS: The participants had a mean age of 40.3 years, a female predominance (74.3%), and a majority of faculty members (51.4%). The internal consistency showed high reliability (> 0.95). Test-retest reliability showed very high correlations (r = 0.93). The CVI for domain 1 was 0.78, for domain 2 was 0.73, and for the entire instrument was 0.75. CONCLUSION: This unique, reliable, and valid measurement tool could accurately measure the level of confidence in writing a standard medical article and in using the appropriate English language for this purpose.

The effect of preoperative statins on postoperative mortality, renal, and neurological complications in patients undergoing cardiac surgeries: a retrospective cohort study.

BACKGROUND: Cardiac surgery is performed worldwide to treat severe cases of cardiovascular diseases. Statins have shown controversial effects on complications after cardiac surgeries. We aimed to investigate the effect of preoperative statin therapy on the frequency of postoperative mortality, renal, and neurological complications. METHODS: In a retrospective cohort study, the database of patients operated on in two hospitals in southern Iran during 2008-2019 was used to compare preoperative statin use with no use on the composite outcome of mortality, renal, and neurological complications as well as on each component of the composite, separately. Effects of low dose (<40 mg simvastatin equivalence) vs. high dose (≥40 mg) statins were also evaluated. Confounders that could affect the outcomes were considered in the logistic regression model, and multiple imputation techniques were used to categorize patients with unknown statin dose use as either high or low-dose users. RESULTS: Of total 7329 patients, 17.6% of statin users and 17% of non-statin users developed the composite outcome (P=0.51). Statin use had no statistically significant association with the composite outcome (aRR 1.01 [95% CI: 0.88-1.16]). There was no significant association with mortality [aRR: 0.75 (95% CI: 0.34-1.69)], neurological [aRR: 1.25 (95% CI: 0.77-2.12)], or renal complications [aRR: 1.03 (95% CI 0.90-1.19)] after surgery. Neither low nor high doses had any statistically significant effect on the composite or any of its components. CONCLUSIONS: In this large study, preoperative statin use, either high dose or low dose, did not affect short-term postoperative mortality, neurological, or renal complications.

The Effect of Mipomersen in the Management of Patients with Familial Hypercholesterolemia: A Systematic Review and Meta-Analysis of Clinical Trials.

Background: Familial hypercholesterolemia (FH) lead to significant adverse effects in coronary arteries. Mipomersen is a second-generation antisense oligonucleotide that inhibits the synthesis of apolipoprotein B-100, an essential component of low density lipoprotein (LDL), and thus decreases the production of LDL. We aimed to determine the effect of mipomersen in patients with FH. Methods: We searched Ovid Medline, Ovid EMBASE, WHO ICTRP search portal, ISI database, the reference lists of relevant articles, and also Google Scholar to retrieve articles. All randomized controlled trials (RCTs) comparing patients with FH receiving mipomersen as an add-on and a parallel group receiving a placebo or no intervention were selected. Results: Five studies with more than 500 patients were included. All had low risk of bias. Pooling data showed that mipomersen probably reduces LDL compared with placebo [mean difference: -24.79, 95% CI (-30.15, -19.43)] but with a moderate level of certainty. There was a high level of evidence for injection site reactions [RR = 2.56, CI (1.47-4.44)] and a low level for increased serum alanine transaminase (ALT) > 3 times upper limit of normal (ULN) [RR = 5.19, CI (1.01-26.69)]. Conclusion: A moderate level of evidence in decreasing serum LDL indicates that we are uncertain if this drug provides benefit in any outcome important to patients. Although a low level of evidence for an increase in serum ALT leaves uncertainty about this adverse effect, injection site reactions in 10% or more of patients can be an important concern.

A systematic review of the efficacy of surgical intervention in the management of symptomatic Tarlov cysts: a meta-analysis.

Introduction: Tarlov cysts (TC) are sacral perineural cysts that are often found incidentally during spinal imaging. In a small fraction, symptomatic TC can cause pain, bowel, bladder and/or sexual dysfunction, as well as motor and sensory deficits. While many surgeons regard TCs as a non-operative entity, there have been suggestions that operative intervention in carefully selected symptomatic patients may be beneficial. The aim of this meta-analysis is to identify whether surgical treatment for symptomatic TCs is beneficial with an acceptable complication profile.Materials and methods: The authors conducted a systematic outcome analysis of symptomatic TCs treated either with surgery or conservatively managed.Results: Sixteen studies (N = 238) met the inclusion criteria for final meta-analysis. The literature search was performed using PubMed, Ovid MEDLINE, CINAHL, and EMBASE databases up to September 2017 and with an updated search in April 2019. The post-operative complication rate in patients undergoing surgical intervention was 16.9 (11.8 to 22.7) and cyst recurrence was 8.5 (3.5 to 15.4). When a complication occurred, the most frequent complication of surgical intervention was the development of a surgical site infection and/or CSF leak. Of the 15 studies reporting long-term follow-up, 81.0 (74.0-88.0) of patients remained symptom-free for more than 1 year (Mean: 27.5 months, SD = 11.5).Conclusion: We rigorously analyse the efficacy of open surgical decompression and repair of symptomatic TCs and corroborate the findings of sustained long-term resolution of symptoms.

Adherence to the Strengthening the Reporting of Observational Studies in Epidemiology Statement in Observational Studies Published in Iranian Medical Journals.

BACKGROUND: Although much medical knowledge comes from observational research, such studies are more prone to confounding and bias than others. This study was conducted to evaluate the adherence of the observational studies published in Iranian medical journals to the STROBE (strengthening the reporting of observational studies in epidemiology) statement. METHODS: In this cross-sectional study, we selected 150 articles of Iranian medical journals, using multistage sampling from Aug 2016 to Jun 2017. The reported items of the STROBE statement in the articles was determined and considered as the adherence of the articles to the statement. The adherence of the articles with different characteristics was compared. RESULTS: The adherence of the articles to the statement varied from 24% to 68% with a mean score of 48%±9%. The lowest mean scores were found in the Result (36%) and Method (49%) sections. The adherence was significantly better in the articles published in the journals indexed in PubMed or Web of Knowledge (ISI) databases (P<0.001) and those written by cooperation of the authors from other countries (P=0.044). CONCLUSION: The evaluated articles in our study had not adequately reported the items recommended by the STROBE statement. This indicates deficiency in key elements for readers to assess the validity and applicability of a study.

The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.

Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation "ethics committee approval", patients' "informed consent", "financial support", "confidentiality", and "conflict of interest". Of 1460 evaluated articles, 443 (30.3%) reported "ethics committee approval", 686 (47.0%) reported "informed consent", 594 (40.7%) reported "financial support", and 341 (23.4%) reported "conflict of interest". 13% of the articles referred to patients' confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported "ethics committee approval", "financial support", and "conflict of interest" significantly more than Persian language journals, but the frequency of "informed consent" was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal's editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard.

From Paper to Practice; Indexing Systems and Ethical Standards.

Currently one of the main goals of editors is to attain a higher visibility for their journals. On the other hand, authors strive to publish their research in journals indexed in eminent databases such as Scopus, Thompson Reuters' Web of Science (ISI), Medline, etc. Therefore, clarifying the standards of indexing is of great importance. One of the most important issues in publication is the ethical considerations, which are mainly described by organizations, such as the International Committee of Medical Journal Editors and the Committee on Publication Ethics. In this study, we examined the ethical requirements of high impact databases for indexing journals to investigate whether they mention or mandate journals to adhere to publication ethics. We found that only Scopus mandated journals to state clear ethical policies on their website as a criterion for being indexed while Medline and Directory of Open Access Journals advised journals to adhere to ethics, not mandated, and Web of Science (ISI) and PubMed Central made no mention of ethics as a required criterion for indexing. Based on this short review, there seems to be a gap between the requirements of indexing systems and international guidelines for publication ethics. Currently, most indexing systems have only partially recommended journals to consider ethical issues. In such an atmosphere, we cannot expect journals or as a result, authors to professionally, completely, and whole heartedly implement ethical guidelines as a mandatory rule in their journals and research, when the indexing systems that most editors want to be indexed in and most authors want to be cited in do not mandate such guidelines.

Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals.

BACKGROUND: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs) form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess the quality of RCT reporting vis-à-vis adherence to CONSORT among articles published in Iranian medical journals (English, Persian, CONSORT-endorsing, and non-CONSORT-endorsing). METHODS: In this cross-sectional study, all RCTs published in all Iranian medical journals from September 2012 to September 2013 were retrieved to evaluate their adherence to CONSORT. The journals' instructions for authors were also reviewed to find out whether or not they endorsed CONSORT. The CONSORT 2010 Checklist was used. Microsoft Excel 2007 was applied to analyze the data, and MedCalc was employed to compare the groups. RESULTS: Totally, 492 pharmacological RCTs that met our inclusion criteria were identified. Twenty-five items were reported in fewer than 50% of the articles. The differences between the articles published in Persian and English language journals were statistically significant in 17 items. The differences between the articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals were significant in 8 items. CONCLUSION: Our findings showed very weak adherence to CONSORT. Authors, reviewers, and editors should be trained to use standards expressed by the CONSORT Group in reporting RCTs.

Amiodarone Versus Propafenone to Treat Atrial Fibrillation after Coronary Artery Bypass Grafting: A Randomized Double Blind Controlled Trial.

BACKGROUND: Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. Several therapeutic and preventive strategies have been introduced for postoperative AF, but the treatment and prophylaxis of AF remain controversial. We aimed to compare the efficacy of intravenous amiodarone and oral propafenone in the treatment of AF after coronary artery bypass grafting (CABG). METHODS: This was a randomized controlled trial performed in two hospitals in Shiraz, Iran from 2009 to 2012. We included all patients who underwent elective CABG and developed AF postoperatively. The patients were randomly assigned to receive propafenone or amiodarone. The duration of AF, the success rate of the treatment, the need for cardioversion, the frequency of repeated AF, and the need for repeating the treatment were compared. RESULTS: The duration of the first (p=0.361), second (p=0.832), and third (p=0.298) episodes of AF, the need for cardioversion (p=0.998), and the need to repeat the first and second doses of drugs (p=0.557, 0.699) were comparable between the study groups. Repeated AF was observed in 17 patients (30.9%) in the propafenone group and 23 patients (34.3%) in the amiodarone group (p=0.704). CONCLUSION: Oral propafenone and intravenous amiodarone are equally effective in the treatment and conversion of recent-onset AF after CABG.

The effects of preoperative statins on the incidence of postoperative acute kidney injury in patients undergoing cardiac surgeries.

OBJECTIVES: Recent evidence has emphasized multifunctional therapeutic effects of statins on renal protection after cardiac surgeries. We aimed to assess the effects of preoperative administration of statins on lowering the incidence of postoperative acute kidney injury in patients undergoing cardiac surgeries. METHODS: In a retrospective study, the preoperative, intraoperative and postoperative data of 1064 consecutive patients who underwent different forms of cardiovascular surgeries were reviewed. According to whether patients had received statins preoperatively, the patients were categorized into no statin (n = 620), low-dose statin (n = 262) or high-dose statin (n = 182) administration groups. RESULTS: No difference was seen in postoperative incidence of acute kidney injury between the three groups (11.1, 9.9 and 11.5%, respectively, P = 0.887). The multivariate logistic regression analysis showed that advanced age [odds ratio (OR) = 1.043, P < 0.001], recent myocardial infarction within 90 days of surgery (OR = 1.935, P = 0.002) and longer intubation time (OR = 1.001, P = 0.001) could predict occurrence of kidney injury after cardiac surgery. The preoperative use of angiotensin converting enzyme (ACE) inhibitor could effectively prevent occurrence of this postoperative event (OR = 0.552, P = 0.008). After adjusting for propensity score only, statin treatment, at low or high doses, was not associated with lower postoperative acute kidney injury (OR = 1.010, P = 0.971 for low dose and OR = 1.108, P = 0.745 for high dose versus no statin). After further adjustment for propensity score, statin treatment with the different dosages was not associated with acute kidney injury (OR = 0.869, P = 0.633 for low dose and OR = 1.051, P = 0.885 for high dose versus no statin). CONCLUSIONS: Preoperative statin use may not inhibit acute kidney injury after operation.

Outcome and graft patency in coronary artery bypass grafting with coronary endarterectomy.

BACKGROUND: Controversy persists regarding the use of coronary endarterectomy (CE) in patients with severe coronary artery disease. We compared the comorbidities and perioperative characteristics of patients undergoing coronary artery bypass grafting (CABG) with and without CE. METHODS: This study was performed in two private hospitals in Shiraz, Iran from May 2010 to December 2011 on 967 patients who underwent CABG without CE and 84 patients who underwent CABG with CE (the CE+ group). After follow-up at 9.66±3.65 months post-surgery, 28 patients from the CE+ group underwent angiography to evaluate the patency of grafts and native coronary vessels. RESULTS: Patients in the CE+ group had a more prevalent history of diabetes (48% vs. 36%) and number of diseased vessels (2.88±0.39 vs. 2.70±0.85). The overall hospital mortality was 1.8%, and no significant difference was observed between the two groups. In the 28 patients who underwent reangiography, 113 vessels were bypassed and 29 endarterectomies were performed, mostly on the left anterior descending artery (12 endarterectomies) and the right coronary artery (8 endarterectomies). In the endarterectomized vessels, a 66% patency rate was found in both the grafts and the native vessels. The native coronary vessels were more likely to be patent when the left internal mammary artery was used as a conduit than when a saphenous vein bypass graft was used. CONCLUSION: The lack of a significant difference in postoperative complications in patients who underwent CABG with or without CE may indicate that CE does not expose patients to a higher risk of complications. Since most of the endarterectomized vessels were shown to be patent during the follow-up period, we propose that endarterectomy is a viable option for patients with severely diseased vessels.

Evaluation of quality of life in children six months after liver transplantation.

BACKGROUND: Liver transplantation (LT) is now performed as a cure for numerous untreatable pediatric liver diseases. Quality of life (QoL) can be affected in pediatric patients with LT. Many factors are responsible for lower scores of QoL. This article aims to detail QoL in liver recipients six months following LT in children. METHODS: WE ASSESSED QOLWITH THE FOLLOWING QUESTIONNAIRES: Child Health Quality-Parent Form 50 (CHQ-PF 50)for parents and Child Health Quality-Child Form 87 (CHQ-CF 87) for children ≥10 years of age in 50 children with LT and their parents. RESULTS: According to the CHQ-PF 50 questionnaire, QoL was found to be significantly lower in LT children compared with healthy children. According to the CHQ-CF 87 questionnaire, QoL was similar in pediatric liver recipients and the normal population. CONCLUSION: According to parents' judgments, childhood liver recipients have impaired QoL. This may be due to multiple factors that include concern about the long term outcome of LT, comparing their child with other children, and complications of LT. On the other hand, older children and adolescents believe their QoL is similar to healthy children. It seems that by decreasing risk factors, we can reduce stress on families and improve QoL.

The impact of coronary artery bypass graft surgery on depression and anxiety.

AIMS: Psychiatric disorders, including depression and anxiety, after coronary artery bypass graft (CABG) surgery are rife. Such disorders can make important impacts on patients. We aimed to evaluate the value of the surgical approach, associated with other medical therapies in decreasing depression and anxiety in a group of patients scheduled for CABG in our center. METHODS: In a prospective study, all patients scheduled for CABG in a 6-month period were selected consecutively to enter a two-stage study. The patients were interviewed using Hamilton Depression and Anxiety Rating Scales before and 4 weeks after the operations. RESULTS: Mean age of men in the anxiety group (68 patients) was significantly lower than that of women. Mean anxiety scores before and after the operations were 8.9 ± 4.7 and 6.7 ± 4.4, respectively (P = 0.026). Mean age of women in the depression group (55 patients) was more than that of men (P = 0.04). Mean scores of depression before and after the operations were 13.30 ± 7.59 and 11.2 ± 7.19, respectively (P = 0.027). Men's scores of anxiety and depression were decreased significantly more than those in women after operations. CONCLUSION: CABG surgery can decrease the level of anxiety and depression in patients scheduled for surgery in a short-term follow-up. This effect is more prominent in men than women.

Optimal management of familial hypercholesterolemia: treatment and management strategies.

Familial hypercholesterolemia is an autosomally dominant disorder caused by various mutations in low-density lipoprotein receptor genes. This will lead to elevated levels of total and low-density lipoprotein cholesterol, which may in turn lead to premature coronary atherosclerosis and cardiac-related death. The symptoms are more severe in the homozygous type of the disease. Different options for the treatment of affected patients are now available. Diet therapy, pharmacologic therapy, lipid apheresis, and liver transplantation are among the various treatments. We clinically review the treatment and management strategies for the disease in order to shed light on the optimal management of familial hypercholesterolemia.

Effects of sex, body mass index, and body size on the outcome of coronary artery bypass surgery: Iranian experience.

OBJECTIVE: Sex, body mass index, and body surface area have been proposed as important determinants of outcome after coronary artery bypass graft surgery. METHODS: In a retrospective study, the archived files of the patients who had undergone isolated coronary artery bypass graft (CABG) in our center from January 2005 to September 2008 were evaluated. The data regarding the patients' body surface area (BSA), body mass index (BMI), and laboratory tests as well as their demographic data and the number of deaths, duration of intensive care unit (ICU) stay, and duration of hospital admissions were collected. Duration of ICU stay >4 days and death were considered for the final outcomes to present the morbidity and mortality, respectively. RESULTS: In total, the files of 1223 patients were reviewed. BSA was different between men and women, but the differences in mortality and morbidity were not statistically significant. The difference between the mean BMI in men and women was not significant (P = 0.72). In all, 11 patients (9 men, 2 women) died during the hospital stay, but no significant difference was observed between the men and the women (P = 0.59). Among the patients, 6.5% stayed >4 days in the ICU (50 men, 20 women) with no significant difference between the two (P = 0.482). No significant differences were found between the BSA and BMI of the patients who died and those who were discharged from the hospital (P = 0.088 and P = 0.321, respectively). There were no significant correlations between the duration of hospital stay and the BSA or BMI (P = 0.44 and P = 0.26, respectively). CONCLUSION: Sex, BMI, and BSA do not affect the outcome after CABG.

Effects of opium addiction on bleeding after coronary artery bypass graft surgery: report from Iran.

PURPOSE: Opium abuse is a major type of drug abuse in Iran. This study was designed to find the possible relation between opium addiction and excessive bleeding after coronary artery bypass graft (CABG) surgery. METHODS: In a historical cohort study during a 1.5-year period, consecutive patients scheduled for elective CABG surgery were assigned to two group on the basis of having or not having the criteria for inhalational opium addiction. Before and after operations, the complete blood count, bleeding time, prothrombin time, partial thromboplastin time, and platelet count were checked for all patients. The volumes of infused red blood cells during and after the operation were recorded. After operations, the volumes of bleeding through the patients' chest tubes were recorded. The recorded data were analyzed using SPSS software version 11.5. Independent t, chi-square and repeated measure tests were used; and P < 0.05 was considered statistically significant. RESULTS: In total, 84 nonaddicted patients were assigned in group 1, and 110 patients who fulfilled the addiction criteria were assigned in group 2. Total bleeding from the three chest tubes was significantly different between the two groups (P = 0.001). The mean hemoglobin level, prothrombin time, partial thromboplastin time, and platelet counts before and after the operations were similar in the two groups. Opium-addicted patients received more packed red blood cells during and after the operations. CONCLUSION: Inhalational opium addiction might lead to more hemorrhage after CABG surgery. It is recommended that cardiac surgeons consider these patients at high risk for major complications after surgery.

Cardiac hemangioma presenting with neurological manifestations.

Primary cardiac tumors are rare. Hemangiomas represent about 5%-10% of benign cardiac tumors. Hemangiomas can be found in any heart chamber, but atria have been more frequently involved. Ventricular involvement is uncommon. Hemangiomas may have various presentations, but there have been few reports about neurological manifestations of such tumors in the English-language literature. We present a patient with a left ventricular hemangioma who presented with leftsided weakness and sudden onset of slurred speech.

Triple coronary artery bypass graft in a 10-year-old child with familial hypercholesterolemia.

Familial hypercholesterolemia is a genetic disorder caused by a mutation in the low density lipoprotein (LDL) receptor gene. The homozygous type of the disease is rare and causes tendon xanthomas and coronary artery disease during the early years of life. Herein we present a 10-year-old child with familial hypercholesterolemia who had three-vessel disease and was a candidate for liver transplantation. To the best of our knowledge, he is one of the youngest such patients reported in the English-language literature who underwent coronary artery bypass surgery.