Background: High-risk neonate defines as one who requires more than the standard monitoring and care offered to a healthy term newborn infant; therefore, early detection of neonatal illness is an important step toward improving newborn survival. Objectives: The objective of this study is to assess the knowledge and health-seeking practices of mothers attending primary health-care centers about WHO recognized danger signs in newborns. Subjects and Methods: A cross-sectional study was carried out in primary health-care centers selected conveniently in Baghdad-Alkarkh district. Participants were 275 mothers of child-bearing age group selected conveniently; the data were collected during the period from March 1 to June 30, 2017. A general questionnaire used for the data collection. Results: About 81% of mothers in study sample listed three or more of the who recognized danger signs. About 71.7% of mothers tend to seek advice or treatment for the illness outside the home. The proportion of good knowledge and health-seeking practices was higher in (Educated, employee, mothers who had a history of antenatal care attendance with higher number of visits). There was no relationship between number of children and family support with seeking care outside the home. Mothers who had good knowledge of danger signs of their babies tend to seek care from health facilities more frequently 75%, and this relation was statistically significant, 61.2% of mothers who perceive illness in newborns delayed seeking advice or treatment outside the home, 66% not taking newborn to the health facilities because they expect self-resolution of the illness. There is good knowledge and perception of mothers toward some danger signs such as fever, poor feeding, and jaundice while fair toward others such as cold body, chest indrawing, and signs of local infections. Conclusion: There are good knowledge and perception of mothers about the WHO recognized danger signs in newborns; however, there is a gap between mothers' knowledge and their health-seeking behavior for sick newborn and explored their deep perceptions, constraints, and various treatments.

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Background: Countries that are facing war disasters are prone to develop outbreak emergencies especially when this is associated with massive displacement of populations or refugees to overcrowded settings, and when the provision of safe water supply and sanitation is a challenge. Objective: To portray the trend of cholera in Iraq for the last 18 years. Methods: Records of cholera cases registered for the last 18 years were reviewed from the Department of Health Statistics of the Iraqi Ministry of Health and categorized according to the 18 Iraqi governorates; the total of each governorate was computed for the whole studied years and then summed to get the total for Iraq. Data were categorized by gender and age. Rates of occurrence were plotted against time (for the period from 2000 to 2017) to define the trend of the disease. Results: The trend of cholera in Iraq showed four peaks, in 2003, 2007, 2012, and 2015, females showed slightly more cases than males, with a higher incidence among adult age group, and more in the southern provinces. Conclusion: The epidemics of cholera in Iraq are getting progressively more frequent, with higher number of cases forming a real burden on the health system and a serious threat to the community. Efficient preventive health plans are needed to overcome this growing problem that may compromise the life of people.

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Background: Bile reflux occurs when the bile flows upward from the duodenum to the stomach and esophagus. It occurs when the pyloric sphincter is damaged or fails to work correctly; bile can enter the stomach and then be transported into the esophagus as in gastric reflux. Objective: This study aims to evaluate clinical findings and the endoscopic and histological changes caused by bile reflux disease on gastric mucosa. Patients and Methods: This is a cross-sectional study carried out at Gastrointestinal Endoscopy Unit in Al-Yarmouk Teaching Hospital in Baghdad during the period from January 2016 to October 2016, upper endoscopy done to 50 patients in the Gastrointestinal Tract Center of Al-Yarmouk Teaching Hospital, in whom there is endoscopic evidence of bile reflux disease and biopsies from gastric mucosa were taken and send for histopathology and Helicobacter pylori examination. Results: Bile reflux was noted in 19 males (38%) and 31 females (62%). Bile reflux disease was more in age below 50 years (29 patients), more in the female, while after the age of 65 years, the male/female ratio was 1.5/1. The most common symptoms were epigastric pain. The most common endoscopic findings were gastric erythema. The major risk factors were cholecystectomy (8%). Pylori were present in about 24% of the patients. Conclusion: Bile reflux disease was more common in young female and cholecystectomy was common risk factor.

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Background: Gastroesophageal reflux disease (GERD) is one of the most common conditions encountered in the in- and outpatient clinic, may present with heartburn and acid regurgitation, and it can be asymptomatic too. Furthermore, chronic recurrent cases lead to potentially preventable complications such as esophageal erosion, stricture, and even ulcers. Objective: The aim of the study is to evaluate the accuracy of history taking from patients with GERD and compare it with endoscopic findings. Patients and Methods: This study was conducted in GIT center, Department of Medicine at Al-Yarmouk Teaching Hospital from November 2017 to March 2018. One hundred patients (65 males and 35 females) referred for oesophagogastroduodenoscopy (OGD) for symptoms suggesting of GERD; the assumed indication of their referral, severity of their condition evaluated using GERD Questionnaire (GERDQ score), and their endoscopic finding were assessed depending on Los Angeles classification of erosive esophagitis. Results: A total of 100 patients were enrolled in this study, including 42 patients had erosive esophagitis and 58 had not. There was statistical significance in the GERDQ score of erosive esophagitis group (9.5 ± 1.2) and nonerosive esophagitis group (8.6 ± 1.98); P < 0.05 showing that significant correlation between the score and the occurrence of erosive esophagitis. GERDQ score and the severity of reflux esophagitis were positively correlated. Conclusion: There was correlation between GERDQ score and the severity of esophageal erosion by endoscope in patients with GERD, GERDQ a valid scoring system that scientifically correlates between clinical symptoms and history findings with the endoscopic result.

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Background: Primary hypothyroidism can be defined as an increase in serum thyroid-stimulating hormone (TSH) level, and the concentration of free T3, free T4, T3, and T4 is low. Hypothyroidism is a prevalent disease mostly affecting middle-aged women. One of the most important determinants of glucose homeostasis is thyroid hormones. Hypothyroid patients have a higher prevalence of insulin resistance and tendency to Type 2 diabetes mellitus than the normal individual. Objective: To investigate the correlation between TSH and hemoglobin A1c (HbA1C) in patients with primary hypothyroidism; so, to study the effects of hypothyroidism on glucose metabolism. Subjects and Methods: Ninety-five Iraqi primary hypothyroidism patients and 40 healthy persons taken as control were selected from Specialized Centre for Endocrinology and Diabetes during the period from June 2017 to January 2018. The patients were diagnosed previously as cases of primary hypothyroidism, and they were on treatment and still on treatment. All patients were sent to investigate TSH, T4, T3, and HbA1c. The patients were subdivided into three main groups: first is uncontrolled nondiabetic primary hypothyroid group (36 patients), second is controlled nondiabetic primary hypothyroid group (43) and third is the diabetic primary hypothyroid group (16 patients). Results: A significant difference (P < 0.05) between HbA1C% in both controlled and uncontrolled hypothyroid groups against the control group, but there is no significant difference (P = 0.08) between the controlled and uncontrolled hypothyroid groups. The TSH relation with HbA1c was found to be significantly positive in the uncontrolled hypothyroid and diabetic, hypothyroid groups (r = 0.401 and 0.58, respectively). Conclusions: Significant increment was found in the level of HbA1c in hypothyroid patients, whether it is controlled or uncontrolled and a positive relationship was observed between TSH and HbA1c% in the uncontrolled and diabetic hypothyroid groups. Diabetes augments the effects of hypothyroidism on HbA1c.

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Context: Under-five mortality rate (U5MR) is the number of deaths since birth up to 5 years of age in a specific year divided by the number of live birth (LB) of the same year × 1000. It is a key indicator of child well-being including health and nutrition status, coverage of child survival interventions, and more broadly of social and economic development. Aim: The aim is to study U5MR and their cause trends in Nineveh Governorate for 10 years (2004–2013). Methodology: Design of the Study: This was a biometric (descriptive) study design. Sample of the Study: Under-five deaths plus LBs for the years 2004–2013 were taken. Research Settings: This study was carried out in Nineveh Governorate/Northwest of Iraq. Data Sources: The data were taken from vital registration system and death certificates. Outcome Measures: Various rates and proportions in addition to Chi-squared test for trend. Results: <5 MR varied from 17.83 in 2004 to 20.28/1000 LB in 2013 being worst in 2007 (26.28/1000LB) most of these deaths were among males. The main causes were respiratory distress syndrome, sepsis, congenital anomalies, infections, pneumonia, and accidents. Conclusions: About 20 children died every year for each of 1000 LBs before reaching their 5^th birthday.

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Background: Diabetes mellitus, particularly type 2, and thyroid dysfunction are the most common endocrine disorders. In addition, thyroid dysfunction is associated with poor glycemic control, and there is increased incidence of thyroid dysfunction in type 2 diabetics. Objectives: This study had been designed to find the frequency of thyroid dysfunction in patients with uncontrolled type 2 diabetes mellitus, the frequency of different types of thyroid dysfunction in this group of patients, the effect of having thyroid dysfunction on the glycemic control, and the glycemic control in patients with well-treated thyroid dysfunction. Patients and Methods: This study is a cross-sectional study which included 500 patients with type 2 diabetes mellitus who had been randomly selected from the patients attending the National Center for Diabetes/Al-Mustansiriya University and the outpatient clinic of Al-Yarmouk Teaching Hospital during the period between August 1, 2016, and July 31, 2017. All of the patients underwent a full history and physical examination, in addition, all of them were sent for random plasma glucose, glycated hemoglobin, and “thyroid-stimulating hormone.” Results: This study showed that 364 patients (72.8% of the sample) had poor glycemic control. Thyroid dysfunction was diagnosed in 67 patients (18.4% of those with poor glycemic control), 43.28% of them were known to have thyroid dysfunction, and the rest of them were discovered to have thyroid dysfunction during the study. Hypothyroidism, including both subclinical and primary types, was diagnosed in 26 patients. Statistical analysis showed that significant association between poor glycemic control and thyroid dysfunction calculated Chi-square was 10.67 and P = 0.001086. Conclusions: This study showed that thyroid disorders are not uncommon in patients with uncontrolled type 2 diabetes mellitus. Hypothyroidism is the most common type of thyroid dysfunction and having thyroid dysfunction whether in the form of hypo or hyperfunction is associated with poor glycemic control and controlling thyroid state result in better glycemic control.

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Background: The introduction of pharmacovigilance (PV) program helps in very early detection of adverse drug reactions (ADRs) and identification of risk factors and various measures to be taken once it happened. This study was aimed at investigating the knowledge and attitude of doctors in a research institute about ADR reporting and suggesting possible ways of improving ADR reporting. Materials and Methods: This study was a cross-sectional, questionnaire-based survey conducted at a tertiary care leprosy hospital which is a research institute. The respondents were doctors and students visiting this institute. The study instrument was a self-developed, prevalidated, semi-structured questionnaire of 25 questions. Results: A total of 55 questionnaires were considered for analysis, giving a response rate of 100%. In all, 87.93% of the respondents were aware about pharmacovigilance, 68.96% were aware of ADR reporting system in India, 91.37% opined that only serious ADR with any medicine should be reported, and 4.3% believed that ADR should be reported only for newly marketed agents. Although 88.79% of the respondents observed an ADR, only 31.03% reported it; 60% were aware about the complete step to be taken after ADR. The general attitude of the respondents about ADR reporting was as follows: ADR reporting should be mandatory (60.34%), voluntary (29.31%), and need base (10.34%) and the preferred mode to report should be phone (34.48%), dropbox (22.41%), E-mail (25.86%), and personal visit (8.6%). Nearly 77.58% of the respondents needed a complete feedback after the ADR reporting. Almost 51.72% of the respondents opted increasing awareness about PV through training/projects/continuing medical education, as the factor encouraging for ADR reporting, and 51.72% opted lack of knowledge about the process of reporting, as the factor discouraging ADR reporting. Conclusion: From the study, it was found that most of the doctors and students were unaware of the ADR reporting forms and their availability which should be sorted out in the institutional setting for better results.

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Hypoxia is defined as decreased levels of oxygen in the cells, which are caused by vascular and pulmonary diseases. The catalysts of hypoxia in the physiological role are important in all living cells, whereas its metabolic dysfunction is related to many diseases. Hypoxia-inducible factors (HIFs) activity should be controlled by providing HIF modules. Forkhead box protein M1 (FOXM1) plays a crucial role in the maintenance and differentiation of airways epithelial cell lining, especially during embryonic life, where it is essential in the formation and proliferation of pulmonary vessels. FOXM1 is overexpressed in the pulmonary artery smooth muscle in response to hypoxia through the elements that are present in the promoters of FOXM1; therefore, it was used to diagnose patients with pulmonary artery hypertension.

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The most serious dural sinus accident following traumatic brain injury is superior sagittal sinus (SSS) injury. It is usually resulted from depressed skull fracture extends to the midline. We present a traumatic superior sagittal sinus injury triggered by the metal ceiling fan blade with its surgical management. Injuries of the SSS have an increased mortality rate in head injured patients. Metallic ceiling-fan head injury differs from the classic traumatic brain injury concerning the presentation, radiology, management, and outcomes.

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Background: Quercetin is one of the dietary flavonoids found in citrus fruits and leafy vegetables as well as seeds and green tea. Its name comes from Quercetum and belongs to flavonol class which is not synthesized in the human body. Many studies revealed a significant effect of quercetin in advancing psychomotor/cognitive performances and reversing the neurotoxin-induced neuronal damage. Therefore, the present study aimed to illustrate the central effect of quercetin on human vigilance and in normal healthy volunteers. Subjects and Methods: A total of fifty healthy volunteers with a mean age of 23 years were enrolled in this experimental study; they were divided into two groups: Group I: twenty healthy volunteers treated with placebo (500 mg/day starch capsule) for 2 weeks and Group II: thirty healthy volunteers treated with quercetin 500 mg/day for 2 weeks. Each volunteer in each group was subjected to vigilance-psychomotor testing by Leeds psychomotor performance tester which measures Psychomotor-vigilance test (PVT) and Cortical arousal activity (CAA). Results: Quercetin produced a more significant effect on total reaction time, recognition reaction time, movement reaction time, fusion index, % fusion (P < 0.01), and flicker percentage (P < 0.05) compared to control, but quercetin produced an insignificant effect on CFF^d, critical flicker-fusion frequency, and flicker index. Conclusion: Quercetin improves psychomotor performance and CAA in normal healthy volunteers.

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Objective: The study was aimed to identify the risk factors for obstetrical brachial plexus palsy (OBPP). Patients and Methods: A retrospective case–control study was designed. A comparison was performed between cases of brachial plexus paralysis (n = 32), with controls without brachial plexus paralysis (n = 30) randomly selected from physical rehabilitation medicine examination. Statistical analysis was performed using the SPSS Package. Results: Independent risk factors for brachial plexus paralysis were macrosomia (birth weight 4000 g; odds ratio [OR] = 12.353; 95% confidence interval [CI] 2.510–60.802, P < 10⁻³), labor dystocia and instrumental vaginal delivery (forceps delivery and vacuum extraction; OR = 8.8; 95% CI 2.743–28.234, P < 10⁻³), and prolonged pregnancy (OR = 1.28; 95% CI 1.066–1.538, P = 0.011); however, vaginal breech delivery (breech presentation or extraction; OR = 3.231; 95% CI 0.598–17.456, P = 0.258), parity (OR = 2.545; 95% CI 0.677–9.565, P = 0.206), shoulder dystocia (OR = 1.957; 95% CI 0.571–6.702, P = 0.367), and after cesarean section (OR = 1.103; 95% CI 0.987–1.234, P = 0.238) do not represent any risk factor. Conclusions: In our population (n = 62), macrosomia, labor dystocia, instrumental vaginal delivery, and prolonged pregnancy were the significant risk factors for neonatal brachial plexus paralysis, while shoulder dystocia, breech deliveries, parity, and cesarean section were not. Despite our small sample, we found three significant risk factors associated with OBPP.

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Context: Renal transplantation is the best treatment for end-stage renal disease, although some complication may arise after transplantation including transplant rejection and infection, each of the two can occur oppositely to the other since the insufficiently suppressed immune system can still attack the graft while excessively suppressed immune system may allow latent virus to reactivate. The best way to diagnose both of the conditions is by immunohistochemical staining using monoclonal antibodies specific for BK virus and C4d. Aims: This study aims to investigate the frequency of antibody-mediated rejection (AMR) and BK virus nephropathy (BKVN) in renal allograft biopsies in Iraq. Settings and Design: The study encompassed 53 renal transplant recipients who developed signs of renal dysfunction. Subjects and Methods: Renal allograft biopsies were collected from centre of nephrology and kidney transplantation and AL-Yarmouk teaching hospital in Baghdad from January to September 2017, biopsies were embedded, sectioned, fixed on slides and stained with hematoxylin and eosin and monoclonal antibodies specific for C4d and BK virus. Statistical Analysis Used: Data were tested using Chi-square test; the analysis was conducted using the available SPSS-24 Package. Results: Samples were obtained from 38 males and 15 females in whom their mean age was 36.0 ± 13.8 years, the average time between transplantation and biopsy was 33.5 ± 22.5 months, and there was 31 donation from related donor and 22 from unrelated donor. The frequency of BKVN was 1.8% and the frequency of AMR was 52%. Conclusions: Using immunostaining of renal allograft biopsies using anti-BKV antibodies and anti-C4d help in identifying the causes of renal impairment after transplantation that otherwise remain hidden.

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Background: Retinoic acid (RA) is one of the most critical molecules in the organic development of human being; it has been implicated in controlling of hundreds of genes which control several processes in human development. Furthermore, RA has negative insult on pregnancy outcome since it has teratogenic potential when used in high doses. Materials and Methods: Human neural stem cells are used in this study to test the effect RA in different doses on cell viability, cellular protein amount, neurite length, neurosphere sizes, reactive oxygen species (ROS) production, and migration distance. Results and Conclusions: Our results show that RA at low doses (2, 5 μM) preserve cell stemness and increase the sizes of neurospheres significantly, but at high doses, it appears that RA has a neurotoxic effect on these stem cells through significant increase in ROS which has negative effects on neurite length and cellular migration.

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Background: Diabetes in pregnancy with macrosomia is an important risk factor for neonatal morbidity and mortality. Prediction of macrosomia is significantly improved by adding ultrasound to clinical findings. Objective: For earlier detection of macrosomia in prepregnancy diabetic mothers using fetal growth profile including biparietal diameter, femoral length, and also abdominal circumference (AC). Patients and Methods: A historical prospective cohort study was performed at National Endocrine and Diabetic Center in addition to the Obstetrics and Gynecology Department at Al-Yarmouk Hospital for 2 years, from September 2014 to 2016. A hundred and sixty pregnant women were enrolled in this study, 80 of them with a history of prepregnancy diabetes mellitus were taken as a patient group and the other 80 pregnant women with a compatible gestational age and without a history of diabetes mellitus were taken as a comparison group. Abdominal ultrasound was done for patients in both groups at 20, 28, and 36 weeks of gestation and then birth weight was measured for each. Results were compared between two groups. Results: The incident of macrosomia was 30% in patient group and 10% in comparison group. Regarding early prediction of macrosomia by ultrasound using biparietal diameter, femoral length, and AC, the results of the current study revealed that those macrosomic babies have higher femoral length, AC but not biparietal diameter in comparison with babies of average weight using ultrasound performed at 20-week gestation and repeated at 28 and 36 weeks. Conclusion: In diabetic mother, fetal macrosomia can be predicted by ultrasound during pregnancy as early as 20-week gestation.

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Background: Early prediction of preeclampsia represents a big dilemma for obstetricians, but the discovery of a novel biomarker highlights the way for its prediction during the early stage of the pregnancy. Objective: The objective of this study was to evaluate serum irisin levels in preeclamptic and healthy pregnant women in the third trimester of pregnancy. Materials and Methods: This study was a prospective case–control study conducted at Al-Yarmouk Teaching Hospital during the period from October 1, 2017, to May 1, 2018. Totally 80 pregnant women were enrolled in the study; 40 of them were preeclamptic patients and the other 40 were healthy pregnant women assigned as a control group. Serum irisin levels were measured to all participants by enzyme-linked immunosorbent assay method. The results were compared for both groups. Results: Serum irisin was lower in preeclamptic patients compared to controls (280.7 vs. 311.3 μg/L, respectively), but the difference was not statistically significant as the P value was 0.189. Conclusion: Irisin might be involved as a biomarker for pregnancy-associated problems such as preeclampsia.

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Background: The prevalence of diabetes mellitus has a major impact on national and global health. Diabetes, a noncommunicable disease, was considered one of the top ten causes of death. Diabetic patients with chronic hyperglycemia have increased risk of macrovascular and microvascular complications in the long term. Diabetes is associated with an increased risk for morbidity from anemia which leads to dysfunction and structural change in all formed elements. Objective: This study focused on the alteration of blood parameters in diabetic patients compared with healthy controls. Materials and Methods: This is a comparative study including 230 patients treated at a specialized center for endocrinology and diabetes from December 2017 to January 2018. Of the total 230 diabetic patients enrolled in this study, 46 were male and 184 were female, their age range was 20–70 years, and they were compared with 100 healthy individuals that served as control group. A questionnaire was administered as data collection form. Body mass index was estimated. Fasting blood glucose, HbA1c, and formed element indices were laboratory investigated and analyzed by using autohematology analyzer (Huroba ABX). Data were statistically analyzed using SPSS software version 17. Results: The results of the current study revealed that there were statistically significant differences in blood parameters such as red blood cell (RBC) and white blood cell (WBC) count, mean cell volume (MCV) level, and red cell distribution width (RDW) level (P ≤ 0.05), whereas no significant differences were recorded in RBC (hemoglobin, hematocrit, mean cell hemoglobin [MHC], and MCH concentration) and platelet (platelet count, MPV, and PDW) parameters (P ≥ 0.05) when compared with the control group. Conclusions: The present study concluded that blood parameters such as RBCs, MCV, RDW, and WBCs are significantly higher among diabetic patients.

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Background: Reactive oxygen species are usually produced by the living cell and have different functions in its normal activity and considered as one of the factors that involved in heart disease. Malondialdehyde (MDA) considered as one of the most indictors of oxidative stress and damage produced as a result of lipid peroxidation. Objectives: The main objective is to evaluate serum oxidative stress by measuring the changes in the level of MDA as a marker of oxidative stress and demonstrate the correlation of MDA with lipid profile in patients subjected to open-heart surgery. Methods: A case–control study was carried out in the Department of Chemistry and Biochemistry, College of medicine, Tikrit University, Tikrit, Iraq. The study was carried out for 50 patients subjected to open-heart surgery recruited from the Medical City/Iraqi Center for Heart Disease and Ibn Al-Bitar Cardiac Surgery Center, Department of Cardiac Surgery, Baghdad, Iraq between October 1, 2017 and March 1, 2018. The levels of MDA and lipid profile were measured in the serum of 50 patients, in three different interval preoperative, early postoperative, and late postoperative and compared with 30 age- and gender-matched controls. Results: The results revealed a statistically significant difference in the serum MDA level between patient during preoperative, early postoperative, and late postoperative stage against control group and significant differences in their MDA levels among all patients' stages. Furthermore, there was a significant positive correlation between serum MDA level and total cholesterol in the early postoperative stage. Conclusions: There was an increase in the level of MDA in the early postoperative stage as an indicator of reperfusion damage that occurs immediately after open-heart surgery which then decreases dramatically with decrease in total cholesterol, triglyceride, low-density lipoprotein-cholesterol (LDL-C), and very-LDL-C.

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Background: Bloodstream infection (BSI) is a life-threatening condition caused by the presence of microorganisms, generally caused by a range of bacteria in the blood. Objectives: The aim of this study was to evaluate the possible role of procalcitonin (PCT) and C-reactive protein (CRP) as biomarkers of pediatric BSI. Methodology: The study was conducted on 150 blood samples collected from the patient who admitted to Children Welfare Teaching Hospital, Medical City, Baghdad. During the period from November 2020 to March 2021, ninety blood samples from them were positive culture and 60 blood samples were negative culture (control group). The isolates were identified depending on the morphological, microscopic examination, and biochemical tests. Moreover, serum was obtained from all participants for the determination of the screening level of human PCT measured by enzyme-linked immunosorbent assay and CRP by slide agglutination test. Results: The results in this study revealed that the mean levels of serum PCT and CRP in Gram-negative group and Gram-positive group were significantly difference from the control group. Conclusions: The adoption of these biomarkers as routine diagnostic tests for sepsis may help in the early diagnosis of pediatric sepsis.

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The much-awaited dream of many educationalists across India has finally turned into reality and we have shifted to the competency-based curriculum for the undergraduates from the 2019 academic year. With close to 4 months into this transition and implementation, we have realized a wide range of strengths-weaknesses-opportunities-challenges (SWOC) and it is the need of the hour to learn from the same and plan our curriculum in such a manner that the execution of the same can be significantly improved in the coming years. Even though, challenges are there, but it is important to understand and have a belief that all this has been done to improve the health care services offered to the general population. In conclusion, the competency-based curriculum for undergraduate students has to be looked upon as an opportunity to produce competent and globally acceptable doctors and thus it is high time that all the stakeholders accept this as a challenge and work in a concerted manner to accomplish the intended goals.

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Background: Over the past years, some immune checkpoint inhibitors (ICPIs) have been approved for clinical use in several malignancies. Examining the effects of ICPIs on the patients' health-related quality of life (HRQoL) may help clinicians in their decision-making process. Aim: The aim of this review is to summarize the current evidence about the effects of ICPIs on the patients' HRQoL. Methods: PubMed, Embase (via OvidSP), Web of Science, Scopus, and EBSCOhost were searched from their dates of inception to January 2018. Studies reporting the effects of ICPIs on the HRQoL using a valid questionnaire are included in the review. A narrative summary of the included studies was presented. Results: Sixteen studies met the specific inclusion criteria, which are as follows: seven about melanoma, three about renal cell carcinoma (RCC), one about metastatic Merkel-cell carcinoma (mMCC), two about squamous cell carcinoma of the head and neck, two about non-small-cell lung cancer (NSCLC), and one about colorectal cancer (CRC). In melanoma, more improvements in the global health status (GHS) were observed with pembrolizumab, ipilimumab 3 mg/kg, and pembrolizumab every 2 weeks than with ipilimumab, ipilimumab 10 mg/kg, and pembrolizumab every 3 weeks, respectively. However, no clinically significant differences were found when adding gp100 vaccine, using different doses of pembrolizumab or combining ICPIs. In RCC, the EQ-5D utility index and the time to deterioration were improved in the nivolumab groups than in everolimus groups. In squamous cell carcinoma of the head and neck, the GHS remained stable or improved with nivolumab. However, there was no significant difference in the time to deterioration between nivolumab and investigator's choice. In mMCC, a slight gain in the GHS was observed with avelumab. In NSCLC, improvements were observed in the symptoms scales and some of the functioning scales with pembrolizumab than chemotherapy. However, no difference was observed between them on emotional functioning. In CRC, some clinically meaningful improvements were observed in nivolumab plus ipilimumab. Conclusion: Due to the complexities in the longitudinal analysis of HRQoL data and some other concerns in the included studies designs, these results should be interpreted carefully. PROSPERO registration number: CRD42018089311

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