One-year Observational Study Research Articles

Associations of hypoglycemia, glycemic variability and risk of cardiac arrhythmias in insulin-treated patients with type 2 diabetes: a prospective, observational study

BackgroundInsulin-treated patients with type 2 diabetes (T2D) are at risk of hypoglycemia, which is associated with an increased risk of cardiovascular disease and mortality. Using a long-term monitoring approach, we investigated the association between episodes of hypoglycemia, glycemic variability and cardiac arrhythmias in a real-life setting.MethodsInsulin-treated patients with T2D (N = 21, [mean ± SD] age 66.8 ± 9.6 years, BMI 30.1 ± 4.5 kg/m2, HbA1c 6.8 ± 0.4% [51.0 ± 4.8 mmol/mol]) were included for a one-year observational study. Patients were monitored with continuous glucose monitoring ([mean ± SD] 118 ± 6 days) and an implantable cardiac monitor (ICM) during the study period.ResultsTime spend in hypoglycemia was higher during nighttime than during daytime ([median and interquartile range] 0.7% [0.7–2.7] vs. 0.4% [0.2–0.8]). The ICMs detected 724 episodes of potentially clinically significant arrhythmias in 12 (57%) participants, with atrial fibrillation and pauses accounting for 99% of the episodes. No association between hypoglycemia and cardiac arrhythmia was found during daytime. During nighttime, subject-specific hourly incidence of cardiac arrhythmias tended to increase with the occurrence of hypoglycemia (incident rate ratio [IRR] 1.70 [95% CI 0.36–8.01]) but only slightly with increasing time in hypoglycemia (IRR 1.04 [95% CI 0.89–1.22] per 5 min). Subject-specific incidence of cardiac arrhythmias during nighttime increased with increasing glycemic variability as estimated by coefficient of variation whereas it decreased during daytime (IRR 1.33 [95% CI 1.05–1.67] and IRR 0.77 [95% CI 0.59–0.99] per 5% absolute increase, respectively).ConclusionsCardiac arrhythmias were common in insulin-treated patients with T2D and were associated with glycemic variability, whereas arrhythmias were not strongly associated with hypoglycemia.Trial registration: NCT03150030, ClinicalTrials.gov, registered May 11, 2017. https://clinicaltrials.gov/ct2/show/NCT03150030

Selective serotonin reuptake inhibitors and fractures in older nursing home residents: Data from the INCUR study

Depression and selective serotonin reuptake inhibitors (SSRI) reduce bone mass and increase fracture risk. We analyzed the association between SSRI use and fractures development in nursing homes residents during a one-year prospective observational study. Sixty-four of the 800 participants developed a fracture during the one-year follow-up. Individuals who developed fractures used SSRIs more often than residents who did not (40.6% vs 28.7%, p =0.045). SSRIs were associated with fractures (adjusted OR 1.76, 95% CI 1.04 – 2.98, p = 0.036). A regular medication review should be performed to reduce inappropriate prescriptions and related adverse consequences.

Exposure to PM2.5 and PM10 and COVID-19 infection rates and mortality: A one-year observational study in Poland

BackgroundAtmospheric contamination, especially particulate matter (PM), can be associated viral infections connected with respiratory failure. Literature data indicates that intensity of SARS-CoV-2 infections worldwide can be associated with PM pollution levels. ObjectivesThe aim of the study was to examine the relationship between atmospheric contamination, measured as PM2.5 and PM10 levels, and the number of COVID-19 cases and related deaths in Poland in a one-year observation study. MethodsNumber and geographical distribution of COVID-19 incidents and related deaths, as well as PM2.5 and PM10 exposure levels in Poland were obtained from publicly accessible databases. Average monthly values of these parameters for individual provinces were calculated. Multiple regression analysis was performed for the period between March 2020 and February 2021, taking into account average monthly exposure to PM2.5 and PM10, monthly COVID-19 incidence and mortality rates per 100,000 inhabitants and the population density across Polish provinces. ResultsOnly December 2020 the number of new infections was significantly related to the three analyzed factors: PM2.5, population density and the number of laboratory COVID-19 tests (R2 = 0.882). For COVID-19 mortality, a model with all three significant factors: PM10, population density and number of tests was obtained as significant only in November 2020 (R2 = 0.468). ConclusionThe distribution of COVID-19 incidents across Poland was independent from annual levels of particulate matter concentration in provinces. Exposure to PM2.5 and PM10 was associated with COVID-19 incidence and mortality in different provinces only in certain months. Other cofactors such as population density and the number of performed COVID-19 tests also corresponded with both COVID-19-related infections and deaths only in certain months. Particulate matter should not be treated as the sole determinant of the spread and severity of the COVID-19 pandemic but its importance in the incidence of infectious diseases should not be forgotten.

ENT manifestations in HIV infected patients in PIMS Islamabad.

INTRODUCTION
 HIV is a global pandemic with estimation of 38 million active cases around the world according to WHO HIV data and statistics 2019. Despite of advancement in medical field the disease has not been tamed uptil now. In this modern era HIV is still considered a taboo in Pakistan, people are reluctant about disclosure of disease, screening of their partners and its treatment which is due to lack of awareness and socio-economic constraints.
 OBJECTIVE
 The aim of this study is to see the incidence of Ear, Nose and Throat (ENT) manifestations in HIV infected people presented in tertiary care hospital of Islamabad.
 MATERIAL AND METHOD
 A one-year observational cross-sectional study conducted in Pakistan Institute of Medical Sciences (PIMS) Islamabad between January 2019 to December 2019. All the HIV infected patients who presented with ear, nose and throat manifestations were recruited in the study. Detailed history and examination were conducted after taking written consent. Analysis included calculations of mean values of quantitative association between ENT symptoms and demographic characteristics. Statistical analysis was estimated using either Chi-square test or t-test. 
 RESULTS 
 Majority of the patients presented with Otological manifestation of which the most common was chronic suppurative otitis media (14.28%). Most common Rhinological/Oropharyngeal manifestation included epistaxis (12.24%) and oral candidiasis (8.16%) respectively. Among neck manifestations cervical lymph adenopathy (18.16%) showed the highest percentage.
 CONCLUSION
 The study shows a local trend of ENT manifestation in which the patient presented in later stage (WHO III) which resembled to the studies carried out in other developing countries showing ineffectiveness of current national HIV/AIDS programme.

Telemedicine Versus In-Person Visits in Postoperative Care in Orthopedic Patients: Follow-Up Study From North India.

Background: Telemedicine is improving healthcare delivery in orthopedic patients but the data regarding this are scarce from India, especially North India.Methodology: During this one-year prospective observational study, all patients with fractures of the upper end of tibia requiring surgical intervention and who consented to avail teleconsultation services were included. All these patients were assessed by patient satisfaction score pre-operatively. Patients were randomly assigned for post-operative care schedules of 5 and 14 days in telemedicine and inpatient visits during their follow-up period.Results: A total of 50 patients were included and the satisfaction rating among the two groups was identical. The average patient satisfaction score (on a 10-point scale) was found to be 9.77 in the inpatient visits based on the one-on-one follow-up group and 9.79 in the telemedicine consultation group.Conclusion: In orthopedics, the implementation of telemedicine can minimize the need for the patient to physically visit the outpatient department. The rates of response and overall patient satisfaction were high in the telemedicine group. However, more efforts should be made to address the limitations and problems of using telemedicine.

Influence of SARS-CoV-2 Virus Infection on the Course of Psoriasis during Treatment with Biological Drugs.

Background and objectives: Biological treatment is an important and effective therapy for psoriasis. During the COVID-19 pandemic, it remains unclear whether this type of therapy affects the course of SARS-CoV-2 infection. The aim of the study was to observe patients with psoriasis undergoing biological or other systemic treatment in relation to the impact of SARS-CoV-2 infection on the course of psoriasis and the COVID-19 disease itself. Materials and methods: A one-year observational study included 57 patients with diagnosed psoriasis who qualified for biological treatment and a group of 68 similar patients who were administered a different systemic treatment. Patients were analyzed monthly for psoriasis (including Psoriasis Area Severity Index (PASI) assessment) and constantly for SARS-CoV-2 infection (telephone contact). Cases of COVID-19 were confirmed by Polymerase Chain Reaction (PCR) at the study center. Results: SARS-CoV-2 infection was confirmed by a positive Real Time Polymerase Chain Reaction (RT-PCR) test in eight patients (14.0%) with psoriasis on biological therapy. None of the cases in this group required hospitalization for COVID-19. Similar data were obtained in the control group. Specifically, 11 (16%) patients were confirmed to be infected with SARS-CoV-2. These results were statistically comparable (p > 0.05). In the group of patients undergoing biological treatment, six (75%) of eight patients developed an exacerbation of psoriasis during SARS-CoV-2 infection, and similar results were noted in the control group, with eight (72%) patients experiencing an exacerbation of psoriasis. Conclusions: Patients with psoriasis who were administered biological treatment or other systemic therapy may experience a mild course of SARS-CoV-2 infection but might also experience a temporary exacerbation of skin lesions.

Incidence and Risk Factors of Thrombocytopenia in Neonates Admitted with Surgical Disorders to Neonatal Intensive Care Unit of Tikur Anbessa Specialized Hospital: A One-Year Observational Prospective Cohort Study from a Low-Income Country.

BackgroundThrombocytopenia is one of the most common hematologic disorders affecting neonates admitted to the neonatal intensive care unit. The aim of this study was to determine the incidence and associated risk factors of neonatal thrombocytopenia in neonates admitted with surgical disorders.MethodsAn observational prospective cohort study was conducted and all neonates admitted to neonatal intensive care unit of Tikur Anbessa Specialized Hospital with surgical disorders were included. Data were collected using a checklist and analyzed by SPSS version 23. Chi square test and independent sample t- test were used to assess the association among different variables.ResultsA total of 210 neonates were included in the study, out of which 56.2% were males. The incidence of thrombocytopenia was 55.8%. Among neonates with thrombocytopenia, 90.9% had late onset thrombocytopenia and half were in the severe range (<50,000/µL). The presence of sepsis (P = 0.000) and atresia (P = 0.000) were found to be significantly associated with the development of thrombocytopenia. The mean non feeding hours were found to be significantly longer for patients with thrombocytopenia (t [199], 5.81, P = 0.000).ConclusionThe incidence of thrombocytopenia is high in our institution. Prevention methods towards neonatal sepsis should be given due emphasis.

Electroconvulsive Therapy (ECT) in Bipolar Disorder Patients with Ultra-Rapid Cycling and Unstable Mixed States.

Background and Objectives: Unstable mixed episodes or rapid switching between opposite affective poles within the scope of short cycles was first characterized in 1967 by S. Mentzos as complex polymorphous states with chaotic overlap of manic and depressive symptoms. Well-known examples include antidepressant-induced mania/hypomania and rapid/ultra-rapid/ultradian cycling, when clinicians observe an almost continuous mixed state with a constant change of preponderance of manic or depressive symptoms. Achieving stable remission in these cases is challenging with almost no data on evidence-based treatment. When mood stabilizers are ineffective, electroconvulsive therapy (ECT) has been suggested. Objectives: After reviewing the evidence from available literature, this article presents our own clinical experience of ECT efficacy and tolerability in patients with ultra-rapid cycling bipolar disorder (BD) and unstable mixed states. Materials and Methods: We conducted an open, one-year observational prospective study with a “mirror image” design, including 30 patients with rapid and ultra-rapid cycling BD on long-term mood stabilizer treatment (18 received lithium carbonate, 6 on valproate and 6 on carbamazepine) with limited effectiveness. A bilateral ECT course (5–10 sessions) was prescribed for regaining mood stability. Results: ECT was very effective in 12 patients (40%) with a history of ineffective mood stabilizer treatment who achieved and maintained remission; all of them received lithium except for 1 patient who received carbamazepine and 2 with valproate. Nine patients (30%) showed partial response (one on carbamazepine and two on valproate) and nine patients (30%) had no improvement at all (four on carbamazepine and two on valproate). For the whole sample, the duration of affective episodes was significantly reduced from 36.05 ± 4.32 weeks in the year prior to ECT to 21.74 ± 12.14 weeks in the year post-ECT (p < 0.001). Depressive episodes with mixed and/or catatonic features according to DSM-5 specifiers were associated with a better acute ECT response and/or long-term mood stabilizer treatment outcome after ECT. Conclusions: ECT could be considered as a useful option for getting mood instability under control in rapid and ultra-rapid cycling bipolar patients. Further randomized trials are needed to confirm these results.

Change in BMI affects the risk of falling in postmenopausal osteopenic and osteoporotic women.

Objectives:To investigate the impact of the body mass index (BMI) change on risk of falling in postmenopausal women with osteopenia or osteoporosis. Also, we aimed to evaluate and associate the individuals’ functionality, mobility and balance with the risk of falling.Methods:This one-year prospective observational study assessed 498 postmenopausal Greek women over the 50th year of age suffering from either osteoporosis or osteopenia. Parameters such as the height, weight and BMI were documented. Furthermore, the subjects were asked whether they experienced a fall the preceding year. Balance was evaluated using the Berg Balance Scale, the Timed-Up-And-Go test, and the 30 Seconds Sit-to-Stand test. Hand-grip strength was assessed with the Jamar Hydraulic Hand Dynamometer.Results:The observed one-year BMI change was associated with falls in postmenopausal osteopenic and osteoporotic women over the age of 70. Additionally, there were statistically significant changes in the BBS, TUG, 30CST and the hand-grip strength on both hands at the one-year follow-up but there were not associated with an increased fall risk.Conclusion:The one-year change in BMI was associated with the risk of falling in postmenopausal osteopenic and osteoporotic women over the 70th year of age. Whereas, the one-year change in balance, mobility and grip strength were not linked to an increased risk of falling.

Longer-term effects of supervised physical activity on obstructive sleep apnea and subsequent health consequences.

Although recent trials have shown promising benefits of exercise on obstructive sleep apnea (OSA) severity, the long-term effect of these interventions remains unknown. The aim of this study was to assess the effect of a 9-month community physical activity program on OSA severity one year later in free-living conditions. OSA patients, previously included in a 9-month randomized controlled trial (EXESAS study) evaluating the effects of supervised community physical activity on OSA severity, were invited to participate in an extra one-year observational study. Twenty-eight patients completed the study. Although OSA severity did not significantly worsen over the real-life period (9 to 21months of follow-up), reductions in apnea-hypopnea index (AHI) and oxygen desaturation index were no longer significant after 21months of follow-up compared to baseline (baseline AHI: 22.2±6.3 /h; 9months: 16.3±6.4 /h; 21months: 18.7±8.9 /h). Benefits observed at 9months on daytime sleepiness and mental health were preserved at 21months, whereas cardiorespiratory fitness slightly decreased. Per-protocol analysis revealed that patients who stopped exercise at 9months had worsened OSA severity compared to those who continued exercise during the real-life period (AHI: +9.0±8.8 vs. -1.3±5.3 /h; p<.01). In conclusion, our study suggested that improvements in OSA severity remain transient and is dependent on long-term adherence to regular physical activity practice.

A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA)

BackgroundWe aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA).MethodsA list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman’s history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as “not important”. In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as “not important” or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study.ResultsFifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women.ConclusionWe established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery.Trial registrationThe INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 (NCT04446780).

Incidence and Risk Factors of Thrombocytopenia in Neonates Admitted With Surgical Disorders to Neonatal Intensive Care Unit of Tikur Anbessa Specialized Hospital; A One-Year Observational Prospective Cohort Study From a Low-Income Country

Background: Thrombocytopenia is one of the most common hematologic disorders affecting neonates who are admitted to the neonatal intensive care unit with a reported incidence of 18-35%. Several maternal, neonatal and perinatal factors contribute to the development of thrombocytopenia. This study is aimed to determine the incidence and associated risk factors of neonatal thrombocytopenia. Methods: An observational prospective cohort study was conducted and all neonates admitted to the neonatal intensive care unit of Tikur Anbessa Specialized Hospital with surgical disorders in the study period were included. Data was collected using a checklist and analysed by SPSS version 23. Chi square test and independent sample T- test were used to asses the association among different variables. Findings: A total of 210 neonates were included in the study out of which 56.2% were males. The incidence of thrombocytopenia in the study period was 55.8%. Among neonates with thrombocytopenia, 90.9% had a late onset thrombocytopenia and half of them were in the severe range (<50,000/µl). The presence of sepsis(P=0.000) and atresia (P=0.000) were found to be significantly associated with the development of thrombocytopenia. The mean non feeding hours were found to be significantly longer for patients with thrombocytopenia (t (199), 5.81, P= 0.000). Interpretation: The incidence of thrombocytopenia in neonates admitted with surgical disorders was high in our institution. Preventive methods towards neonatal sepsis including antenatal and postnatal measures should be given due emphasis. Initiation of oral feedings in neonates as early as feasible is recommended. Funding Statement: Addis Ababa University has granted the fund for this study. Declaration of Interests: None. Ethics Approval Statement: Written informed consent was taken from parents of enrolled neonates and each neonate’s clinical data was kept in confidential manner using a coding system. Ethical clearance for this study was obtained from ethical board of the medical college.

Treatment of idiopathic nephrotic syndrome with two steroid dosing regimens - one-year observational study.

IntroductionThe aim of the study was to compare the first year of disease in children with idiopathic nephrotic syndrome (INS) treated according to two prednisone dosing regimens: a weight-based schedule (2 mg/kg/24 h in the 1st month, 2 mg/kg/48 h in the 2nd month, with dose tapering during the following 4 months), and a body surface area (BSA)-based schedule (60 mg/m2/24 h in the 1st month, 40 mg/m2/48 h in the 2nd month, with dose tapering during the following 4 months).Material and methodsIn 2 groups of children treated with weight- and BSA-based regimens (20 patients, 3.13 ±1.01 years, treated in 2010-2013 and 20 patients, 5.13 ±2.86 years, treated in 2014-2016) clinical and anthropometrical parameters, number of INS relapses, total prednisone dose (mg/kg/year), and steroid adverse effects were compared during the first year of disease.ResultsChildren treated with the weight-based steroid regimen received a higher total annual prednisone dose (259.06 ±79.54 vs. 185.83 ±72.67 mg/kg/24 h, p = 0.004) and had a shorter (though not significantly) period without prednisone (38.25 ±55.83 vs. 75.90 ±73.06 days, p = 0.062) compared to patients treated with the BSA-based regimen. There was no difference in number of relapses between groups (2.20 ±1.64 vs. 1.60 ±1.67, p = 0.190) but more patients relapsed in the weight-based group (19/20 vs. 13/20, p = 0.044). No differences in Z-score values of height, weight, and body mass index (BMI) were observed. No steroid-related adverse events were noted except for arterial hypertension (4/20 vs. 5/20 patients, p = 1.000).ConclusionsThe BSA-based regimen of prednisone dosing in children with INS reduces exposure to steroids and risk of relapse, as well as increases days off steroids in the first year compared to the weight-based regimen with a high second-month dose.

Pemafibrate improves hepatic inflammation, function and fibrosis in patients with non-alcoholic fatty liver disease: a one-year observational study.

Aim of the studyTo optimize the long-term outcomes of patients with non-alcoholic fatty liver disease (NAFLD), long-term therapy is important to prevent cirrhosis and hepatocellular carcinoma. Pemafibrate, a novel selective peroxisome proliferator-activated receptor-α modulator, is a promising therapeutic agent for patients with NAFLD. However, only short-term clinical studies are currently available. The aim of this study is to evaluate the long-term outcomes of patients with NAFLD treated with pemafibrate.Material and methodsThis is a retrospective observational study. Patients with NAFLD treated with pemafibrate 0.1 mg twice daily for one year were retrospectively reviewed.ResultsTwenty-two patients without diabetes mellitus were included and analyzed. Regarding hepatic inflammation markers, alanine aminotransferase (ALT) significantly decreased during the first three months and was maintained. Low-density lipoprotein and triglycerides significantly decreased at three months and were maintained. Regarding markers of hepatic function, the albumin-bilirubin score decreased significantly during one year of therapy due to significantly elevated serum albumin and decreased total bilirubin levels. Regarding markers of fibrosis, Mac-2 binding protein glucosylation isomer (M2BPGi) significantly decreased, and platelet count increased significantly. Next, we performed correlation analysis between changes in M2BPGi and other parameters. Changes in aspartate aminotransferase, ALT and triglycerides positively correlated with the change in M2BPGi.ConclusionsOne-year pemafibrate therapy improves markers of hepatic inflammation, function and fibrosis in non-diabetic patients with NAFLD. Improvement of hepatic fibrosis markers significantly correlates with improvement of hepatic inflammation markers and triglyceride levels.

Long-Term Adherence to Positive Airway Pressure Therapy in Saudi Ambulatory Patients with Obesity Hypoventilation Syndrome and Severe Obstructive Sleep Apnea: A One-Year Follow-Up Prospective Observational Study.

PurposeLong-term studies assessing positive airway pressure (PAP) therapy adherence in patients with obesity hypoventilation (OHS) are limited. The aim of this study was to assess PAP therapy adherence in Arab (Saudi) patients with OHS and an apnea-hypopnea index (AHI) >30/h.MethodsA prospective cohort study of consecutive adult patients diagnosed with OHS between March 2010 and September 2019 was conducted. During the therapeutic sleep study, all OHS patients were started on continuous PAP (CPAP). Patients who failed to maintain oxygen saturation ≥88% despite the elimination of obstructive respiratory events were shifted to bi-level PAP (BPAP). Objective assessment of adherence was performed at 1, 6, and 12 months after initiating PAP therapy. We adopted the American-Thoracic-Society criteria for PAP adherence.ResultsThe study included 101 patients (women = 65 patients) with OHS, an AHI ≥30/h, and a mean age of 54.9 ± 12.7 years. Successful titration on CPAP was achieved in 64.4% of the patients and BPAP was required for 35.6% of the patients who failed CPAP titration. At the end of the study, 43.6% of the patients used PAP therapy in an acceptable manner. Adherence after 1 and 6 months was the only independent predictors of adherence at 12 months.ConclusionPAP adherence among Saudi patients with OHS and severe obstructive sleep apnea was relatively low. Almost two-thirds of patients tolerated CPAP titration with the elimination of respiratory events and desaturation. Early adherence to PAP therapy was the only predictor of PAP therapy adherence at the end of the study.

Predicting Cognitive Decline in Parkinson's Disease with Mild Cognitive Impairment: A One-Year Observational Study.

We conducted an observational study to investigate clinical predictors of cognitive decline in patients with mild cognitive impairment (MCI), with a focus on patients with Parkinson's disease (PD) and Alzheimer's disease (AD). The study was performed with detailed neuropsychological testing, a portable device for gait analysis, and a comprehensive geriatric assessment for patients with MCI. Cognitive decline was defined as subjective cognitive impairment with an objective decline in the Mini-Mental State Examination (MMSE) ≥2 points at the one-year follow-up. Participants (n = 74) had a median age of 70 (interquartile range 60–79) years, and 45.9% of them were women. At the end of the study, 17.6% of the patients with MCI had a cognitive decline. Although no differences were observed between groups at the baseline cognitive study, patients with PD-MCI demonstrated more cognitive decline than patients with AD-MCI (28.6% vs. 7.7% p = 0.03). Patients with PD-MCI had more physical disabilities, including scores of instrumental activities of daily living (IADL), Tinetti balance, and gait scores, and some Timed Up and Go components. Initial Clinical Dementia Rating—Sum of Boxes score was a better predictor of future cognitive decline than MMSE in PD-MCI. For predicting the occurrence of cognitive decline in PD-MCI, the prediction accuracy increased from the reduced model (AUC = 0.822, p < 0.001) to the full model (a total of five independent variables, AUC = 0.974, p < 0.001). Given the potentially modifiable predictor, our findings also highlight the importance of identifying sleep quality and the ability to perform IADL.

Epidemiology of out-of-Hospital Cardiac Arrests, knowledge of cardiovascular disease and risk factors in a regional setting in India: The Warangal Area out-of-hospital Cardiac Arrest Registry (WACAR)

ObjectiveOut-of-Hospital Cardiac Arrest (OHCA) is a global public health problem. There is inadequate data on OHCA in India. The Warangal Area out-of-hospital Cardiac Arrest Registry (WACAR) was planned to understand OHCA in a regional setting in India. MethodsWACAR is a prospective one-year observational cohort study of OHCA in the Warangal area, Telangana, India. The study included 814 subjects of OHCA of presumed cardiac etiology brought to the Mahatma Gandhi Memorial Hospital during January 1, 2018, and December 31, 2018. The data collected included; standard Utstein variables with additional data on clinical characteristics (modified Utstein template). ResultsThe majority of OHCA subjects were male with a median age of 60 years, and mostly occurring in residential locations within 1 h of onset of symptoms. Individuals with knowledge of CVD risk factors were more likely to report symptoms before OHCA. Data on resuscitation characteristics were inadequate. ConclusionsThe WACAR study provides baseline data regarding OHCA in a regional setting in India. The study demonstrated barriers involving data collection, patient knowledge of CVD risk factors and disease, and access to healthcare, which; impacted the data registry.

Efficacy and tolerability of perampanel as a first add-on therapy with different anti-seizure drugs

PurposeTo investigate the efficacy and tolerability of perampanel (PER) when administered as a first add-on therapy to patients with focal epilepsy or idiopathic generalized epilepsy (IGE) taking one other antiseizure drug (ASD). MethodsThis multicentre, retrospective, one-year observational study collected data from patients (≥12 years) who initiated treatment with PER as first add-on therapy. Patients had to be experiencing inadequate seizure control on ASD monotherapy and tried ≤3 ASD monotherapies before initiating PER. Multivariate logistic regression analyses were performed, adjusted for the number and type of previous seizures, duration and aetiology of epilepsy. ResultsOf the 149 patients included in the study (mean age 41 years; 54.4 % male), 118 (79.2 %) were still receiving PER as first add-on treatment after 12 months. Mean PER dose was 6.2 mg/day. At 12 months, 45.6 % were seizure-free and 84.6 % responders. A significant difference in seizure freedom rate was found between patients with IGE and patients with focal epilepsy, but not in responders. Reduced seizure control was observed when PER was administered with strong enzyme-inducing ASDs; conversely, increased seizure control was seen when the same dose of PER was combined with enzyme-inhibiting ASDs. The most frequent adverse events were dizziness (15.4 %), irritability (14.1 %) and drowsiness (14.1 %); no differences in tolerance were observed among different combinations. ConclusionPER demonstrated a good efficacy and safety profile when used as a first add-on therapy in patients who did not respond to monotherapy. PER dose adjustments may optimize seizure control when combined with strong enzyme-inducing or enzyme-inhibiting ASDs.

The analysis of the lipid levels in patients with coronary artery disease after percutaneous coronary intervention: a one-year follow-up observational study

BackgroundCoronary heart disease (CHD) is one of the leading causes of death worldwide. Percutaneous coronary intervention (PCI) has been an important technology for the treatment of CHD. Blood lipid management is critical for PCI patients because not only should local vascular pathological changes be considered but the whole atherosclerotic process should be considered as well.MethodsA total of 522 patients diagnosed with CHD (including acute myocardial infarction and unstable angina) successfully underwent stent implantation in acute or elective PCI in the cardiology department of one general hospital in Guangzhou from June 2015 to December 2017. The 2016 Chinese Guideline for the Management of dyslipidaemia in Adults and the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report (NCEP-ATP III) were used to classify total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels.ResultsA total of 522 patients were recruited for the study. The mean values of TC, TG, LDL-C, and HDL-C at baseline were 4.76, 1.80, 2.93 and 1.03 mmol/L, respectively. After 1 year of follow-up, the mean values of TC, TG, LDL-C, and HDL-C were 3.94, 1.62, 2.26 and 1.01 mmol/L, respectively. The prevalence of high TC, high TG, high LDL-C and low HDL-C at baseline was 12.05, 21.80, 10.90 and 56.79%, respectively, and the prevalence at follow-up was 4.59, 15.68, 3.25 and 59.85%, respectively. Logistic regression revealed that gender was risk factor for high TC (≥ 6.22 mmol/L), low HDL-C (< 1.04 mmol/L) and high LDL-C (≥ 4.14 mmol/L) at follow-up. Age was the factor associated with high TG (≥ 2.26 mmol/L) and low HDL-C (< 1.04 mmol/L) at follow-up. Besides, smoking and diet control were risk factors for low HDL-C (< 1.04 mmol/L) and high LDL-C (≥ 4.14 mmol/L) at follow-up, respectively.ConclusionThe patients with PCI at follow-up experienced lower mean values of lipids and prevalence of dyslipidaemia than those at baseline. Gender, age, smoking and diet control were the risk factors associated with elevated lipids. Improvement in lipid management at follow up demonstrated that such intervention can be effective.

976-P: Evaluation of Hybrid Closed-Loop Insulin Delivery System for Patients with Type 1 Diabetes in Real-World Clinical Practice: A One-Year Qualitative Observational Study

The MiniMed™ 670G (670G) is the first FDA approved hybrid closed-loop insulin delivery system for patients with type 1 diabetes (T1D). In Auto Mode, the integrated continuous glucose monitor (CGM) captures glucose values every five minutes and, via a built-in algorithm, the 670G system automatically adjusts basal insulin delivery targeting a glucose value of 120 mg/dL. Impact of the use of 670G system on patient reported outcomes in people with T1D are limited. Data over one year of use in real world-clinical practice were collected. We evaluated 53 patients with T1D (mean age 46.8±11.8 years, 62% females, body weight 82.5±17.6 kg, BMI 28.7±5.5, HbA1c 7.6±0.8%) who started 670G at the Joslin Clinic between December 2017 and December 2019. Data were collected at baseline and after 12 months. We assessed SROs by administering surveys: 36 Item Short-Form Health Survey (SF 36), Pittsburgh Sleep Quality Index (PSQI), and hypoglycemia fear survey/worry scale (HFS_W). We also measured HbA1c, % time-in-range at baseline and 12 months, and % time in auto mode (TiAM) for the two weeks preceding the final study visit. At 12 months, A1C decreased by 0.3±0.1% from baseline (p&amp;lt;0.01) and % time-in-range increased by 7.9±3.1% from baseline (p=0.015) with no correlation between either of them and %TiAM (p=0.3, p=0.2 respectively). Physical functioning increased by 47.5% from baseline (p&amp;lt;0.001), and HFS_W improved significantly by -16.0% from baseline (p=0.017). At 12 months, average %TiAM was 60.4±33.7% and was not associated with clinical outcomes or SROs. We conclude that use of 670G for a year in real-world clinical practice was associated with significant improvement in A1C, % time-in-range, physical functioning and hypoglycemia fear. Neither of these improvements at 12 months was related to %TiAM. Disclosure A.H. Eldib: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. S.E. Dhaver: None. H. Gardner: None. M. Tasabehji: None. M. Albadri: None. A. Atakov-Castillo: None. E. Toschi: None. O. Hamdy: Consultant; Self; Abbott, AstraZeneca, Merck &amp; Co., Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.