Type 2 diabetes mellitus and In-hospital Major Adverse Cardiac and Cerebrovascular Events (MACCEs) and postoperative complications among patients undergoing on-pump isolated coronary artery bypass surgery in Northeastern Iran.

BACKGROUND: Diabetes Mellitus (DM) is a rapidly growing disorder worldwide, especially in the Middle East. A higher incidence of coronary artery diseases requiring coronary artery bypass graft (CABG) surgery has been reported in patients with diabetes. We assessed the association between type 2 diabetes mellitus (T2DM) and in-hospital major adverse cardiac and cerebrovascular events (MACCEs) and postoperative complications among patients who underwent on-pump isolated CABG. METHODS: In this retrospective cohort study, we used the data registered for CABG patients from two heart centers in the Golestan province (North of Iran) between 2007 and 2016. The study population included 1956 patients divided into two groups: 1062 non-diabetic patients and 894 patients with diabetes (fasting plasma glucose ≥126 mg/dl or using antidiabetic medications). The study outcome was in-hospital MACCEs, a composite outcome of myocardial infarction (MI), stroke and cardiovascular death, and postoperative complications, including postoperative arrhythmia, acute atrial fibrillation (AF), major bleeding (defined as reoperation due to bleeding), and acute kidney injury (AKI). RESULTS: During the 10-year study period, 1956 adult patients with a mean (SD) age of 59.0 (9.60) years were included. After adjustment for age, gender, ethnicity, obesity, opium consumption, and smoking, diabetes was a predictor of postoperative arrhythmia (AOR 1.30, 95% CI 1.08-1.57; P = 0.006). While it was not a predictor of in-hospital MACCEs (AOR 1.35, 95% CI 0.86, 2.11; P = 0.188), AF (AOR 0.85, 95% CI 0.60-1.19; P = 0.340), major bleeding (AOR 0.80, 95% CI 0.50, 1.30; P = 0.636) or AKI (AOR 1.29, 95% CI 0.42, 3.96; P 0.656) after CABG surgery. CONCLUSION: Findings indicated that diabetes increased the risk of postoperative arrhythmia by 30%. However, we found similar in-hospital MACCEs, acute AF, major bleeding, and AKI following CABG surgery in both diabetic and non-diabetic patients.

Physical Restraint and Associated Factors in Adult Patients in Intensive Care Units: A Cross-sectional Study in North of Iran.

Background/aim: Patients in the intensive care units (ICUs) are at high risk of developing delirium and agitation. Physical restraint (PR) has increased to control these patients which accompanies by adverse consequences. The aim was to determine the PR use and associated factors in patients hospitalized at the ICUs in the North of Iran. Materials and methods: In this cross-sectional study, a total of 272 patients in 3 ICUs of 5 Azar referral hospital affiliated to Golestan University of Medical Sciences (Gorgan, Iran) in 2018 were included. Confusion assessment method for the ICU (CAM-ICU), Richmond Agitation-Sedation Scale (RASS), acute physiology and chronic health evaluation II (APACHE II), and Glasgow Coma Scale (GCS) were used to evaluate delirium, sedation level, disease severity, and level of consciousness, respectively. Analysis was done by STATA version 14.2 (StataCorp LP, College Station, Texas), univariate and multiple analyses. Results: Data from 272 patients were analyzed (mean age of 45.8 ± 21.3 years). PR was used for 74.5% of patients. Restrained patients had more severe disease [mean of APACHE II score, 20.20 (7.5) vs 11.6 (7.1)], longer length of stay [mean of 10 (5.5) vs 5.5 (4.6) days], and lower level of consciousness [mean of GCS score, 8.7 (3.5) vs 13.5 (3.3)] than patients without it. CAM-ICU was positive in majority of patients (79.5 vs 10.4%) and agitation level of RASS score was higher in restrained patients (31.7 vs 3.0%). Associated factors in multiple analysis were use of sedative and psychoactive drugs [odds ratio (OR), 2.85; 95% confidence interval (CI): 1.04-7.82], presence of delirium (OR, 15.13; 95% CI: 4.61-49.65), deep sedation (OR, 0.04; 95% CI: 0.00-0.45), and GCS score (OR, 0.69; 95% CI: 0.53-0.9). Conclusion: This study revealed the high use of PR in the ICUs, and use of sedative and psychoactive drugs, presence of delirium, deep sedation, and GCS score were such associated factors. How to cite this article: Nomali M, Ayati A, Yadegari M, Nomali M, Modanloo M. Physical Restraint and Associated Factors in Adult Patients in Intensive Care Units: A Cross-sectional Study in North of Iran. Indian J Crit Care Med 2022;26(2):192-198.

Osteoporosis e-learning courses: A systematic review to develop a comprehensive virtual course for General Practitioners.

Purpose: One of the key strategies for effective management of osteoporosis is training health care professionals on early diagnosis and treatment of osteoporosis according to a structured course. The aim was to investigate the e-learning courses on osteoporosis around the world in order to develop an online course on osteoporosis management for general practitioners (GPs). Methods: In this review, the Web of Science, Scopus, PubMed, Embase, and ERIC databases and the Google search engine were searched until March, 2021.Then, the contents of the eligible courses were extracted by two researchers independently and verified. After that, the content for an online course for GPs was developed and approved by a panel of experts constituted of endocrinologists, orthopedists, and other specialties involved in the management of osteoporosis to develop the final online course for GPs. Results: In this review, 22 e-learning courses provided through 3 studies, and 19 websites were included. The content of the osteoporosis e-learning course was categorized into ten thematic categories including bone health, osteoporosis definitions and pathophysiology, prevention of osteoporosis, diagnosis of osteoporosis, fractures, non-pharmacological treatments, pharmacological treatments, treatment follow-up, postmenopausal considerations and hands-on work. The final modules for the osteoporosis e-learning contained five main categories, including bone measurement and fracture risk assessment, diagnosis of osteoporosis, clinical management, monitoring and follow-up, and sarcopenia. Conclusion: Through a systematic approach, we developed modules for e-learning of osteoporosis management, which can be used to improve knowledge and skills of GPs in their practice in our setting. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01361-8.

Efficacy of a self-monitoring traffic light diary on outcomes of patients with heart failure: A randomized controlled trial.

BACKGROUND AND OBJECTIVE: Patients with heart failure experience high hospitalization. However, patients cannot recognize symptoms according to current approaches, which needs to be improved by new self-monitoring instruments and strategies. Thus, we aimed to assess a self-monitoring traffic light diary on outcomes of patients with heart failure. METHODS: This was a single-blind, two-arm parallel group randomized controlled trial at the heart failure clinic of Tehran Heart Center (Tehran, Iran). Adult patients with a definitive diagnosis of heart failure with reduced ejection fraction (i.e., ejection fraction of less than 40 %), and New York Heart Association functional classes II-IV were included. A block-balanced randomization method was used to assign eligible subjects to the intervention or control group. Baseline data were collected before random allocation. Participants in the intervention group received a comprehensive intervention consisting of (1) self-care education by an Australian Heart Foundation booklet on heart failure, (2) regular self-monitoring of weight and shortness of breath at home, and (3) scheduled call follow-ups for three months. Patients in the control group received usual care. The primary outcome was heart failure self-care; the secondary outcomes were heart failure quality of life, knowledge, and all-cause hospitalization. RESULTS: From June to August 2017, 68 patients were included in the study. The overall age of participants was 55 (13.6) years old, and 71 % of patients were male. A significant association between the intervention and self-care maintenance (ß 5.1; 95 % CI 2.50 to 7.70, P < 0.001), self-care management (ß 10.6; 95 % CI 6.50 to 14.8, P < 0.001), self-care confidence (ß 8.0; 95 % CI 5.0 to 11.0, P < 0.001) and heart failure knowledge (ß 1.7; 95 % CI 1.30, 2.04; P < 0.001) was found. However, there was no association between the intervention and quality of life (ß 2.5; 95 % CI -0.79, 5.88, P 0.135) and hospitalization-free survival of the two groups (Log-Rank P 0.540). CONCLUSION: A self-monitoring traffic light diary can improve self-care behaviors and heart failure knowledge in patients with heart failure with reduced ejection fraction. RCT APPROVAL ID: Iranian Registry of Clinical Trials IRCT2017021032476N1. STUDY PROTOCOL: PMCID: PMC6262204.

Omega-3 supplementation and outcomes of heart failure: A systematic review of clinical trials.

BACKGROUNDS: Omega-3 supplements are endorsed for heart failure (HF) patients to reduce hospitalizations and mortality, offering anti-inflammatory and cardioprotective benefits. METHODS: A comprehensive search was conducted in various databases until November 2022. Eligible studies included clinical trials on patients with HF. Data extraction covered study details, omega-3 specifics, outcomes, and limitations. The JADAD scale was used to assess the risk of bias in randomized controlled trials. RESULTS: The review process involved 572 records from database searches, resulting in 19 studies after eliminating duplicates and screening. These studies assessed the impact of omega-3 on various clinical outcomes, such as mortality, hospitalization, cardiac function, and quality of life. Studied duration varied from weeks to years. Omega-3 supplementation demonstrated potential benefits such as improved heart function, reduced inflammation, and decreased risk of cardiovascular events. CONCLUSION: Omega-3 supplementation could benefit heart disease treatment, potentially reducing therapy duration and improving outcomes. Starting omega-3 supplementation for HF patients seems favorable.

Validity of the models predicting 10-year risk of cardiovascular diseases in Asia: A systematic review and prediction model meta-analysis.

We aimed to review the validity of existing prediction models for cardiovascular diseases (CVDs) in Asia. In this systematic review and meta-analysis, we included studies that validated prediction models for CVD risk in the general population in Asia. Various databases, including PubMed, Web of Science conference proceedings citation index, Scopus, Global Index Medicus of the World Health Organization (WHO), and Open Access Thesis and Dissertations (OATD), were searched up to November 2022. Additional studies were identified through reference lists and related reviews. The risk of bias was assessed using the PROBAST prediction model risk of bias assessment tool. Meta-analyses were performed using the random effects model, focusing on the C-statistic as a discrimination index and the observed-to-expected ratio (OE) as a calibration index. Out of 1315 initial records, 16 studies were included, with 21 external validations of six models in Asia. The validated models consisted of Framingham models, pooled cohort equations (PCEs), SCORE, Globorisk, and WHO models, combined with the results of the first four models. The pooled C-statistic for men ranged from 0.72 (95% CI 0.70 to 0.75; PCEs) to 0.76 (95% CI 0.74 to 0.78; Framingham general CVD). In women, it varied from 0.74 (95% CI 0.22 to 0.97; SCORE) to 0.79 (95% CI 0.74 to 0.83; Framingham general CVD). The pooled OE ratio for men ranged from 0.21 (95% CI 0.018 to 2.49; Framingham CHD) to 1.11 (95%CI 0.65 to 1.89; PCEs). In women, it varied from 0.28 (95%CI 0.33 to 2.33; Framingham CHD) to 1.81 (95% CI 0.90 to 3.64; PCEs). The Framingham, PCEs, and SCORE models exhibited acceptable discrimination but poor calibration in predicting the 10-year risk of CVDs in Asia. Recalibration and updates are necessary before implementing these models in the region.

Ethnic Disparities in Major Adverse Cardiac and Cerebrovascular Events (MACCEs) and Postoperative Outcomes Following Coronary Artery Bypass in Northeastern Iran (2007-2016).

BACKGROUND: Turkmens are an ethnic group mainly living in northeastern Iran. Despite previous studies on coronary artery bypass surgery (CABG) outcomes among different ethnicities, the effect of Turkmen ethnicity on outcomes of CABG surgery is still unknown. We aimed to assess the association between Turkmen ethnicity and postoperative outcomes following CABG. METHODS: We used the CABG data from two heart centers in northeastern Iran between 2007 and 2016. We included adult patients undergoing CABG surgery. The study outcomes were in-hospital major adverse cardiac and cerebrovascular events (MACCEs), consisting of myocardial infarction (MI), stroke, and cardiovascular death, and postoperative outcomes, including postoperative arrhythmia, acute atrial fibrillation (AF), major bleeding, and acute renal failure (ARF). RESULTS: Over the course of one decade, 3632 patients, with an average age (standard deviation) of 59.0 (9.8) years, were studied. Of these, 3,331 patients were of non-Turkmen ethnicity, and 301 patients were Turkmens. According to adjusted analysis, ethnicity was not associated with MACCEs (OR: 1.15, 95 % CI: 0.61, 2.16; P=0.663), postoperative arrhythmia (OR: 1.10, 95% CI: 0.78, 1.54; P=0.588), acute AF (OR: 1.17, 95 % CI: 0.83, 1.66; P=0.359), major bleeding (OR: 1.21, 95 % CI: 0.55, 2.67; P=0.636), or ARF (OR: 2.60, 95 % CI: 0.60, 11.75, P=0.224). CONCLUSION: This study found that despite ethnic disparity and preoperative differences, Turkmen ethnicity was not associated with in-hospital MACCEs, AF, major bleeding, or ARF after coronary artery bypass.

Challenges and solutions in clinical research during the COVID-19 pandemic: A narrative review.

Background and Aims: The COVID-19 pandemic has presented significant challenges to clinical research, necessitating the adoption of innovative and remote methods to conduct studies. This study aimed to investigate these challenges and propose solutions for conducting clinical research during the pandemic. Methods: A narrative review was conducted (approval ID: IR.AMS.REC.1401.029), utilizing keyword searches in PubMed and Web of Science (WOS) citation index expanded (SCI-EXPANDED) from January 2020 to January 2023. Keywords included COVID-19, clinical research, barriers, obstacles, facilitators and enablers. Results: Out of 2508 records retrieved, 43 studies were reviewed, providing valuable insights into the challenges and corresponding solutions for conducting clinical research during the COVID-19 pandemic. The identified challenges were categorized into four main groups: issues related to researchers or investigators, issues related to participants and ethical concerns, administrative issues, and issues related to research implementation. To address these challenges, multiple strategies were proposed, including remote monitoring through phone or video visits, online data collection and interviews to minimize in-person contact, development of virtual platforms for participant interaction and questionnaire completion, consideration of financial incentives, adherence to essential criteria such as inclusion and exclusion parameters, participant compensation, and risk assessment for vulnerable patients. Conclusion: The COVID-19 pandemic has significantly impacted clinical research, requiring the adaptation and enhancement of existing research structures. Although remote methods and electronic equipment have limitations, they hold promise as effective solutions during this challenging period.

Risk factors of in-hospital mortality for isolated on-pump coronary artery bypass graft surgery in the northeast of Iran from 2007 to 2016.

BACKGROUND AND OBJECTIVE: Coronary artery bypass graft (CABG) surgery is the most common cardiac surgery worldwide. The reported mortality rates for this operation vary greatly. We aimed to determine the risk factors of in-hospital mortality for isolated on-pump CABG surgery. METHODS: This was a large-scale retrospective cohort study of two heart centers in Golestan province. Patients over the age of 18 from both genders who underwent isolated on-pump CABG procedures from 2007 to 2016 were included. The study outcome was in-hospital mortality, which was determined according to the clinical records of study patients. RESULTS: A total of 3704 patients were included in the study, and 63% were men. In-hospital mortality occurred in 2.8% (n=103) of the patients. The median (IQR) age of survived and not-survived patients were 59 (53-65) and 62 (55-75) years, respectively. 44% of the mortalities occurred in patients older than 65, while 28% of the survivors were older than 65. Multivariable logistic regression indicated that emergency CABG (OR 4.52, 95% CI, 1.45, 14.02; P = 0.009) and cardiopulmonary bypass time (CPB) (OR 1.004, 95% CI 1.001, 1.008; P = 0.034) were the risk factors of in-hospital mortality. The area under the receiver operating characteristic (ROC) curve (AUC) of the model consisting of operative and preoperative variables was 0.70 (acceptable performance). CONCLUSION: Our study revealed an acceptable mortality proportion for CABG surgeries conducted in the region. Emergency CABG and CPB time were the main risk factors for in-hospital mortality after CABG.

Adoption of IWGDF guidance on prevention and management of foot problems in diabetes for local use in Iran by ADAPTE methodology: a step toward best practice.

Purpose: Adoption of international working group on the diabetic foot (IWGDF) guidance on prevention and management of foot problems in patients with diabetes was the study aim. Methods: The ADAPTE process consisted of three main phases of set-up, adoption, and finalization with overall 24 steps was used. In set- up phase, organizing committee by a multidisciplinary approach was established. In adoption phase, comprehensive search in databases and guideline resources was done. According to the inclusion criteria, the 2015IWGDF guidance was selected for adoption process. Quality, currency, content and consistency of the guidance were assessed. Also, consensus on different level of agreement for each recommendation were reported. On finalization phase, the adopted version was reviewed by the guidance developer and the final guidance for local use in Iran was disseminated. Results: The 2015 IWGDF guidance with 77 recommendations was adopted after screening of 1760 documents retrieved from Jan. 2006 to Nov. 2016. An organizing committee was established according to a multidisciplinary approach including 73 members with endocrinology, orthopedic & vascular surgery, dermatology, infectious diseases, physical medicine and rehabilitation specialties, general practitioners and nurses. This guidance obtained a good quality in all six domains of AGREE II instrument (Score ≥ 80%), good currency, content, and consistency. Also, during the third round of Delphi, the consensus on the agreement level of each recommendation were greater than 80% and 77 recommendations of the original guidance were kept in the adopted version. Conclusion: The 2015 IWGDF guidance with 77 recommendations adopted for local use in different health care settings of Iran. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-022-01121-0.

The risk of confusion between AstraZeneka COVID-19 vaccine side effects and signs of COVID-19 infection: a case report.

Post-vaccination side effects of AstraZeneca (AZ) coronavirus disease 2019 (COVID-19) vaccine are common. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection immediately after the first dose of AZ COVID-19 vaccine has not been reported. In this case, a 30-year-old female without a past medical history of SARS-CoV2 infection presented to an outpatient clinic with lightheadedness and weakness 2 hours after getting the first dose of the AZ COVID-19 vaccine. Blood pressure (BP) was 80/60 mm Hg, and oxygen saturation (SpO2) was 98%. After administering normal saline intravenous fluid, the BP was 110/80 mm Hg. On the first day, fever (oral temperature of 39℃), sweating, dry cough, sore throat, and injection-site pain were presented. On the second day, diarrhea, productive cough, and hypotension occurred in addition to fever (oral temperature of 39.9℃). The fever did not stop and productive cough, change in smell, and fatigue were reported. SpO2 was 96%. On the third day, no abnormality of the spiral lung computed tomography and the positive reverse transcriptase-polymerase chain reaction (RT-PCR) test were reported. Simultaneously, two out of three members of the family became symptomatic on the second day and their RT-PCR tests were positive. Dexamethasone ampule, Cefixime tablet, Acetaminophen tablet, and Diphenhydramine syrup were prescribed. After a week, fever subsided and SpO2 was 98%. After 3 weeks of self-quarantine at home, her general condition improved. Despite the similarity between SARS-CoV2 infection signs and symptoms and AZ COVID-19 vaccine side effects, none of the approved vaccines contain the live virus that causes disease. Therefore, any unusual post-vaccination signs and symptoms should not be attributed to the vaccine itself and need to be considered for further evaluations and early actions in order to prevent the spread of the disease in society.

Challenges of Type 2 Diabetes Mellitus Management From the Perspective of Patients: Conventional Content Analysis.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) face significant challenges in the treatment process, which can have a negative impact on disease management. Proper management of the disease can reduce symptoms and complications, improve glycemic indices, and reduce mortality and readmission. OBJECTIVE: Given the influential role of patients in prevention and self-care, this study was conducted to explore the challenges of diabetes management from the perspective of patients. METHODS: Two rounds of focus group discussions with T2DM patients were conducted. The principal investigator of the study and a research assistant compiled a list of volunteer patients with names and contact information and selected participants based on their medical information. Participants were chosen via a purposive sampling technique. The questions were designed to encourage patients to share their views on how the treatment team communicates and participates in treatment, how they are trained, and the health care system. The discussion continued until data saturation. During 2 rounds of focus group discussions, the voices of the participants were recorded by 2 voice recorders, and one of the team members was a transcriber. After discussion, participant views were transcribed, and common issues were identified, sorted, and reported as categories and subcategories. RESULTS: According to the conventional content analysis, 88 primary codes were extracted from the detailed and in-depth description of the participants. The codes were summarized after repeated readings and classified based on their similarities and semantic relevance. Through analysis and comparison, 4 categories and 7 subcategories were identified: communication challenges (poor medical staff communication, lack of psychological support), challenges to participation in treatment (lack of patient participation), educational challenges (training program bugs, inadequate training), and challenges of the health care system (inefficiency of the care system, caregiver inefficiency). CONCLUSIONS: This study showed that the treatment team members should pay more attention to the challenges of care and treatment from the perspective of patients with T2DM. Therefore, recommendations for future policies to overcome these obstacles include establishing a multidisciplinary health care team; using trained health care workers to provide organized treatment and care services; holding individual counseling sessions with patients in need of counseling; and providing counseling services, involving patients in the treatment and self-care process, and designing a comprehensive diabetes education program with an emphasis on education. Necessary information should be provided to the patients, and effective communicate should address patient concerns.

Time to Treatment and In-Hospital Major Adverse Cardiac Events Among Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (PCI) According to the 24/7 Primary PCI Service Registry in Iran: Cross-Sectional Study.

BACKGROUND: Performing primary percutaneous coronary intervention (PCI) as a preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI) may be associated with major adverse cardiocerebrovascular events (MACCEs). Thus, timely primary PCI has been emphasized in order to improve outcomes. Despite guideline recommendations on trying to reduce the door-to-balloon time to <90 minutes in order to reduce mortality, less attention has been paid to other components of time to treatment, such as the symptom-to-balloon time, as an indicator of the total ischemic time, which includes the symptom-to-door time and door-to-balloon time, in terms of clinical outcomes of patients with STEMI undergoing primary PCI. OBJECTIVE: We aimed to determine the association between each component of time to treatment (ie, symptom-to-door time, door-to-balloon time, and symptom-to-balloon time) and in-hospital MACCEs among patients with STEMI who underwent primary PCI. METHODS: In this observational study, according to a prospective primary PCI 24/7 service registry, adult patients with STEMI who underwent primary PCI in one of six catheterization laboratories of Tehran Heart Center from November 2015 to August 2019, were studied. The primary outcome was in-hospital MACCEs, which was a composite index consisting of cardiac death, revascularization (ie, target vessel revascularization/target lesion revascularization), myocardial infarction, and stroke. It was compared at different levels of time to treatment (ie, symptom-to-door and door-to-balloon time <90 and ≥90 minutes, and symptom-to-balloon time <180 and ≥180 minutes). Data were analyzed using SPSS software version 24 (IBM Corp), with descriptive statistics, such as frequency, percentage, mean, and standard deviation, and statistical tests, such as chi-square test, t test, and univariate and multivariate logistic regression analyses, and with a significance level of <.05 and 95% CIs for odds ratios (ORs). RESULTS: Data from 2823 out of 3204 patients were analyzed (mean age of 59.6 years, SD 11.6 years; 79.5% male [n=2243]; completion rate: 88.1%). Low proportions of symptom-to-door time ≤90 minutes and symptom-to-balloon time ≤180 minutes were observed among the study patients (579/2823, 20.5% and 691/2823, 24.5%, respectively). Overall, 2.4% (69/2823) of the patients experienced in-hospital MACCEs, and cardiac death (45/2823, 1.6%) was the most common cardiac outcome. In the univariate analysis, the symptom-to-balloon time predicted in-hospital MACCEs (OR 2.2, 95% CI 1.1-4.4; P=.03), while the symptom-to-door time (OR 1.4, 95% CI 0.7-2.6; P=.34) and door-to-balloon time (OR 1.1, 95% CI 0.6-1.8, P=.77) were not associated with in-hospital MACCEs. In the multivariate analysis, only symptom-to-balloon time ≥180 minutes was associated with in-hospital MACCEs and was a predictor of in-hospital MACCEs (OR 2.3, 95% CI 1.1-5.2; P=.04). CONCLUSIONS: A longer symptom-to-balloon time was the only component associated with higher in-hospital MACCEs in the present study. Efforts should be made to shorten the symptom-to-balloon time in order to improve in-hospital MACCEs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13161.

Effect of Self-Management Program on Self-efficacy and Medication Adherence in Patients with Mechanical Heart Valve: a Randomized Clinical Trial.

Introduction: Patients with mechanical heart valve need anticoagulant therapy to prevent thrombotic events. The treatment interacts with some foods and drugs. The aim was to evaluate the effect of self- management program on self-efficacy and medication adherence in patients with mechanical heart valve. Methods: This was a randomized controlled trial. eighty eligible patients, with the ability to read and speak in Farsi, aged between 15 to 60, were included in the study from the cardiac surgery clinic in Imam Khomeini hospital affiliated to Tehran University of Medical Sciences (Tehran, Iran) and randomly allocated to intervention and control groups. The participants had no history of psychiatric disorders, had undergone valve replacement surgery at least one year before the study, and were being treated with Warfarin. The intervention was a combination of 2 one- hour self-management education via small groups with 3 to 5 members, self-management educational booklets, and weekly call follow- ups for 8 weeks about 10- 15 minutes. The control group received no intervention. Self- efficacy was the primary outcome and medication adherence, Prothrombin Time (PT), and International Normalized Ratio (INR) were secondary outcomes. Data were analyzed using spss13. Results: Although the mean of self-efficacy and medication adherence, PT, and INR values were not different between the two groups at baseline, they improved significantly following the program. Conclusion: Self-management program had a positive effect on self-efficacy and medication adherence of patients with mechanical heart valve.

Effect of Illness Perception Correction - Based Educational Program on Quality Of Life and Self- Care in Patients with Heart Failure: a Randomized Controlled Trial.

Introduction: Because of the chronic nature of Heart Failure (HF), low Quality of Life (QoL) and poor self-care are prevalent among patients with HF. Thus, the aim of this study was to evaluate the effect of illness perception correction- based educational program on QoL,and self- care in patients with HF. Methods: In this randomized controlled trial, 78 eligible patients were included in the study from Rajaei Heart Center (Tehran, Iran) and randomly assigned into intervention and control group with 1:1 allocation ratio. The intervention was a combination of illness perception correction- based education program (30- minute sessions over 3 consecutive days) and 10-minute phone calls made once a week in the course of 8 weeks. The control group received usual care. The primary outcome was quality of life and secondary outcomes were self- care and illness- perception which were measured at baseline and at the end of the study. SPSS version 13 was used for the analysis. Results: Out of 76 eligible patients, 70 patients with HF finished the study. Although the mean of quality of life, self-care, and illness perception were not different at baseline, QoL (45.2 (8.3) VS 66.8 (15.4); P<0.001), self-care (18.5 (4.5) VS 37.1 (7.2); P<0.001), and illness- perception (183.6 (8.4) VS 151.2 (24.5); P<0.001) improved following the program in the intervention group in comparison to the control group. Conclusion: According to the study findings, this program can be applied by nurses for patients with HF as a discharge plan in order to improve their QoL, self-care, and their illness perception.

Prevalence of Malnutrition Among Elderly People in Iran: Protocol for a Systematic Review and Meta-Analysis.

BACKGROUND: Malnutrition occurs following a decrease or an imbalance in the absorption of energy, protein, vitamins, and minerals because of numerous factors. Thus, it has serious and life-threatening consequences. To plan for this issue, we need information on the burden of this problem. OBJECTIVE: The aim of this study is to determine the prevalence of malnutrition among elderly people in Iran. METHODS: For the purpose of this study, papers, including original articles, theses, and conference proceedings on the prevalence of malnutrition among people aged 60 years and above, and have been published in national and international journals until September 2018 will be included without any language limitation. The following keywords along with their synonyms in Persian will be used in the literature search: malnutrition, elderly, and Iran. At first, the screening process will be conducted based on our inclusion and exclusion criteria. Then, the full text of the remaining articles will be read carefully, and eligible articles will be selected according to the objectives of the study. Next, the methodological quality of the selected papers will be reviewed, and the required information will be extracted from those with acceptable quality. Finally, a meta-analysis will be performed using the Stata software (version 14) when optimum criteria are met. It should be noted that all stages of screening, selection, quality assessment of primary studies, and data extraction will be performed by two reviewers independently. RESULTS: This review is ongoing and will be completed at the end of 2019. CONCLUSIONS: This review aims to provide comprehensive evidence about the prevalence of malnutrition among elderly people in Iran. This can help Iranian health managers and policy makers make informed decisions for preventing malnutrition and promoting the health status of elderly people. TRIAL REGISTRATION: PROSPERO CRD42018115358; https://tinyurl.com/y28su47m. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15334.

Time to Treatment and In-Hospital Major Adverse Cardiac Events Among Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (PCI) According to the 24/7 Primary PCI Service Registry in Iran: Protocol for a Cross-Sectional Study.

BACKGROUND: Patients with ST-segment elevation myocardial infarction (STEMI) experience major adverse cardiac events (MACEs) following primary percutaneous coronary intervention (PCI). Although the relationship between time to treatment (eg, door-to-balloon time, symptom onset-to-balloon time, and symptom onset-to-door time) and 1-month all-cause mortality was assessed previously, its relationship with in-hospital MACEs and the effect of some clinical characteristics on this relationship were not considered. Furthermore, previous studies that were conducted in developed countries with a different quality of care cannot be applied in Iran, as Iran is a developing country and the studies were not performed according to the 24/7 primary PCI service registry. OBJECTIVE: The objective of this study protocol is to determine the relationship between time to treatment and in-hospital MACEs. METHODS: This cross-sectional study will take place at the Tehran Heart Center (THC), which is affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. Data related to patients with STEMI, who underwent primary PCI between March 2015 and March 2019, that have been prospectively recorded in the THC's 24/7 primary PCI service registry will be analyzed. The study outcome is the occurrence of in-hospital MACEs. Data analysis will be conducted using SPSS for Windows, version 16.0 (SPSS Inc). We will perform chi-square tests, independent-samples t tests, or the Mann-Whitney U test, as well as univariate and multivariate binary logistic regression with a significance level of less than .05 and 95% CI for odds ratios. RESULTS: From March 2015 to September 2017, 1586 patients were included in the THC service registry, consecutively. We will conduct a retrospective analysis of this registry on patient entries between March 2015 and March 2019 and data will be analyzed and published by the end of 2019. CONCLUSIONS: To our knowledge, this is the first observational study based on the 24/7 primary PCI service registry in Iran. The findings of this study may reveal current problems regarding time to treatment in STEMI management in the THC. Results from this study may help determine appropriate preventive strategies that need to be applied in order to reduce time-to-treatment delays and improve patients' outcomes following primary PCI in the setting of STEMI at the THC and similar clinical centers. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13161.

Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial.

BACKGROUND: Patients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies. OBJECTIVE: This study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives. METHODS: A single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys. RESULTS: This study is ongoing and is expected to be completed by the end of 2018. CONCLUSIONS: This is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/9209.

Introducing a New Technique for Limb Prepping in Orthopedic Surgeries: Designing, Construction, and Evaluation of Limb-Lifting Assistive Device.

Lifting and holding patients' limbs while preparing the skin for orthopedic surgeries may be a lengthy process causing work-related musculoskeletal disorders (MSDs) for preoperative team members. Studies reported weight limits for lifting and holding limbs; whenever this weight is greater than a specific amount, additional staff or assistive devices are needed because nurses and support staff working in orthopedic operating rooms (ORs) are at high risk of MSDs. The aim of this study was to demonstrate the design, construction, and effectiveness of a limb-lifting assistive device installed in the OR of 5 Azar Hospital affiliated with Golestan University of Medical Sciences and used during the surgical preparation process.

Relationship between Serum Level of Interleukin-2 in Patients with Systemic Lupus Erythematosus and Disease Activity in Comparison with Control Group.

BACKGROUND: Despite the large number of surveys, there are not any validated biomarkers for SLE disease activity till now. This study aimed to evaluate the relationship between serum level of IL-2 in patients with SLE and disease activity in comparison with control group. MATERIALS AND METHODS: In this case-control study, 73 patients with lupus and 73 healthy subjects referred to the rheumatology clinic of 5 Azar Hospital in Gorgan (North of Iran).They were studied via convenience sampling during 2011-2012. Blood samples were taken from both groups and serum levels of interleukin -2 measured by Avi Bion Human IL-2 ELISA kit. Serum Level of IL-2 greater than 15 pg/ml defined positive and lesser than this amount defined negative. Disease activity evaluated with SLE disease activity index. Score greater than or equal to three or four defined as active disease. Data analysis conducted by SPSS software (version 16) and by using descriptive statistics and statistical tests. RESULTS: Serum level of IL-2 was positive in 45.2% of sample studied and negative in 54.8% in case group, while in control group, serum level of IL-2 only in 11% of sample studied was positive and in 89% was negative. Statistical analysis indicated a significant relationship between serum level of IL-2 and the SLE disease activity index (p=0.025). CONCLUSION: This study showed the relationship between serum levels of IL-2 and disease activity, so this biomarker can be used as a clinical indicator for assessing disease activity in patients with SLE.