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Introduction: Intrathoracic lymph node metastasis from extrathoracic neoplasms are rare. Primary malignancies that metastasize to mediastinal-hilar lymph nodes are head and neck , carcinoma breast ,and genitourinary. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)/endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently the preferred modality for mediastinal lymph node sampling. Methods: Fifty seven patients with extrathoracic malignancies with maximum standardized uptake value (SUVmax) of mediastinal-hilar lymph nodes greater than or equal to 2.5 were taken up for EBUS-TBNA. The histo-cytopathological results obtained from EBUS-TBNA were compared with SUVmax value and short-axis diameter of a lymph node as noted on EBUS. Results: Out of 74 sampled nodes, 49 (66.2%) were benign and 25 (33.8%) were malignant. The SUVmax range of benign nodes was 2.8� as compared to 3� of malignant nodes. The size range of malignant and benign nodes were 8� mm and 8� mm, respectively. The mean size of abnormal nodes (metastatic + granulomatous) was 17.5 (8� mm) and the mean SUVmax was 9.1 (3.4�), and it was a statistically significant difference when compared to reactive (normal) nodes. At SUVmax cut-off 7.5, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) were 78.5%, 81.2%, 84.6%, and 74.2%, respectively for detecting abnormal nodes. At 13 mm size cut-off, sensitivity, specificity, PPV, NPV were 75.5%, 65%, 75%, and 72%, respectively, for detecting abnormal nodes. Conclusion: The majority of mediastinal-hilar nodes with increased metabolic activity are benign in nature. Size and SUVmax are poor predictors of metastasis in tuberculosis endemic region. There should be a restrictive attitude toward invasive diagnostic testing for mediastinal-hilar nodes in extrathoracic malignancies.
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Background: There is an increasing prevalence of coronary artery disease (CAD) in younger individuals. Lipid biomarkers such as lipoprotein-a (Lp-a), Apo A1, Apo B and Paraoxonase-1 (PON1) serve as important risk predictors for development of CAD. There is little evidence regarding the role of lipid biomarkers and their genetic polymorphisms in young (<50 years) ST-segment elevation myocardial infarction (STEMI) patients. Methods: This study included 110 young (18e50 years) STEMI patients and 110 healthy controls. Serum levels of Apo A1, Apo B, Paraoxonase-1 (PON-1) and Lipoprotein-associated phospholipase A2 (Lp-PLA2) were estimated for both patients as well as controls. Additionally, genetic polymorphisms in the Apo A1 (75G/A) and the PON1 (Q192R) genes were evaluated. Results: Serum levels of apo B (101.31 ± 27.58 vs 75.31 ± 18.77 mg/dl; p < 0.0001), Lp(a) [87.56 ± 74.28 vs 25.81 ± 24.66 mg/dl, p < 0.0001] and Lp-PLA2 [5.97 ± 1.39 vs 3.49 ± 1.27 ng/mL, p < 0.0001] were significantly higher in patients as compared to controls. Serum levels of Apo A1 [44.76 ± 35.65 vs 95.97 ± 29.89; p < 0.0001] and PON1 [2.63 ± 1.5 vs 3.87 ± 1.47 ng/mL, p < 0.0001] were significantly lower in cases as compared with controls. Additionally, patients with genetic polymorphisms in the Apo A1 (75G/A) and the PON1 (Q192R) gene had an increased risk of STEMI. Conclusion: Lipid biomarkers such as Apo A1, Apo B and PON1 and their genetic polymorphism are associated with the susceptibility for STEMI in young individuals.
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Objective: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). Methods: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. Results: We included nine studies with a total of 2865 patients (plug-based n ¼ 1631, suture-based n ¼ 1234). There was no significant difference in primary outcome of all bleeding when using plugbased as opposed to suture-based VCDs (RR 1.14 [0.62e2.06] I2 ¼ 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38e3.58] I2 ¼ 65%), major vascular complications (RR 0.84 [0.35e2.00] I2 ¼ 55%), minor vascular complications (RR 1.05 [0.56e1.95] I2 ¼ 42%), pseudo aneurysm (RR 1.84 [0.11e29.98] I 2 ¼ 44%), stenosis-dissection (RR 0.98 [0.66e1.47] I2 ¼ 0%), VCD failure (RR 1.71 [0.96e3.04] I2 ¼ 0%), and blood transfusion (RR 1.01 [0.38e2.71], I2 ¼ 61%). Conclusion: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.
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Objectives: In India, poverty, illiteracy, and difficult terrains make the tea garden elderly population more vulnerable to malnutrition. The food environment shows the interface through which consumers interact with their food system. Hence, the present study was done to assess the nutrition status and identify the sociodemographic and food environmental factors affecting the nutritional status of the elderly population residing in tea gardens of Naxalbari block, Darjeeling district, West Bengal, India. Materials and Methods: A community-based cross‑sectional study was conducted in all tea gardens of Naxalbari block, Darjeeling, from March 2022 to September 2022, among older people aged 60 years and above selected by simple random sampling. Using the predesigned, pretested questionnaire, the Mini Nutritional Assessment tool for nutritional assessment and the elderly population’s perceived food environment was determined based on five points Likert’s scale. Perceived food environment clusters were identified using a two‑stage cluster analysis. Binary logistic regression was used to determine predictors of nutritional status. Results: Out of the 294 study participants, the majority of 190 (64.6%) of the older people were at the risk of malnutrition, 18 (6.1%) malnourished, and 86 (29.3%) had normal nutritional status. Binary logistics regression showed older people who were illiterate (adjusted odds ratio [AOR] 14.864; 95% confidence interval [CI]; 4.311–51.457) and not working (AOR 3.775; 95% CI; 1.753–8.128) had significantly higher odds of being undernourished. Older people who perceived a favorable food environment (AOR 0.408; 95% CI; 0.214–0.775) had significantly lesser odds of being undernourished. Conclusion: Tea garden older population is at higher risk of malnutrition. Illiteracy, working status, and perceived favorable food environment plays important role in altering the nutritional status of the elderly. Prior interventions such as awareness regarding food nutrition and developing elderly friendly food environment are needed.
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Background@#No meta-analysis has analysed efficacy and safety of fast-acting aspart insulin (FIAsp) with insulin pump in type 1 diabetes mellitus (T1DM). @*Methods@#Electronic databases were searched for randomised controlled trials (RCTs) involving T1DM patients on insulin pump receiving FIAsp in intervention arm, and placebo/active comparator insulin in control arm. Primary outcome was to evaluate changes in 1- and 2-hour post-prandial glucose (1hPPG and 2hPPG). Secondary outcomes were to evaluate alterations in percentage time with blood glucose <3.9 mmol/L (hypoglycaemia), time in range (TIR) blood glucose 3.9 to 10 mmol/L, insulin requirements and adverse events. @*Results@#Data from four RCTs involving 640 patients was analysed. FIAsp use in insulin pump was associated with significantly greater lowering of 1hPPG (mean difference [MD], –1.35 mmol/L; 95% confidence interval [CI], –1.72 to –0.98; P<0.01; I2=63%) and 2hPPG (MD, –1.19 mmol/L; 95% CI, –1.38 to –1.00; P<0.01; I2=0%) as compared to controls. TIR was comparable among groups (MD, 1.06%; 95% CI, –3.84 to 5.96; P=0.67; I2=70%). Duration of blood glucose <3.9 mmol/L was lower in FIAsp group, approaching significance (MD, –0.91%; 95% CI, –1.84 to 0.03; P=0.06; I2=0%). Total hypoglycaemic episodes (risk ratio [RR], 1.35; 95% CI, 0.55 to 3.31; P=0.51; I2=0%), severe hypoglycaemia (RR, 2.26; 95% CI, 0.77 to 6.66; P=0.14), infusion site reactions (RR, 1.35; 95% CI, 0.63 to 2.93; P=0.77; I2=0%), and treatment-emergent adverse events (RR, 1.13; 95% CI, 0.80 to 1.60; P=0.50; I2=0%) were comparable. @*Conclusion@#FIAsp use in insulin pump is associated with better post-prandial glycaemic control with no increased hypoglycaemia or glycaemic variability.
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Methods@#Adult patients who underwent an ACDF procedure in 2007–2016 were included. Patient records were extracted from MarketScan, a national registry that captures person-specific clinical utilization, expenditures, and enrollments across millions of inpatient, outpatient, and prescription drug services. Propensity-score matching (PSM) was employed to match the patient cohorts across demographic characteristics, comorbidities, and treatments. @*Results@#Of 110,911 patients, 65,151 (58.7%) received BC implants while 45,760 (41.3%) received SA implants. Patients who underwent BC surgeries had slightly higher reoperation rates within 1 year after the index ACDF procedure (3.3% vs. 3.0%, p=0.004), higher postoperative complication rates (4.9% vs. 4.6%, p=0.022), and higher 90-day readmission rates (4.9% vs. 4.4%, p =0.001). After PSM, the postoperative complication rates did not vary between the two cohorts (4.8% vs. 4.6%, p=0.369), although dysphagia (2.2% vs. 1.8%, p<0.001) and infection (0.3% vs. 0.2%, p=0.007) rates remained higher for the BC group. Other outcome differences, including readmission and reoperation, decreased. Physician’s fees remained high for BC implantation procedures. @*Conclusions@#We found marginal differences in clinical outcomes between BC and SA ACDF interventions in the largest published database cohort of adult ACDF surgeries. After adjusting for group-level differences in comorbidity burden and demographic characteristics, BC and SA ACDF surgeries showed similar clinical outcomes. Physician’s fees, however, were higher for BC implantation procedures.
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Methods@#The MarketScan database was queried from 2007 to 2016 to identify adult patients who were ≤65 years old, and underwent ACDF using the international classification of diseases 9th version and current procedural terminology codes. Nearest neighbor propensity-score matching was employed to balance patient demographics and operative characteristics between myelopathic and nonmyelopathic cohorts. @*Results@#Of 107,480 patients who met the inclusion criteria, 29,152 (27.1%) were diagnosed with myelopathy. At baseline, the median age of patients with myelopathy was higher (52 years vs. 50 years, p <0.001), and they had a higher comorbidity burden (mean Charlson comorbidity index, 1.92 vs. 1.58; p <0.001) than patients without myelopathy. Patients with myelopathy were more likely to undergo surgical revision at 2 years (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.54–1.73) or are readmitted within 90 days (OR, 1.27; 95% CI, 1.20–1.34). After patient cohorts were matched, patients with myelopathy remained at elevated risk for reoperation at 2 years (OR, 1.55; 95% CI, 1.44–1.67) and postoperative dysphagia (2.78% vs. 1.68%, p <0.001) compared to patients without myelopathy. @*Conclusions@#We found inferior postoperative outcomes at baseline for patients with myelopathy undergoing ACDF compared to patients without myelopathy. Patients with myelopathy remained at significantly greater risk for reoperation and readmission after balancing potential confounding variables across cohorts, and these differences in outcomes were largely driven by patients with myelopathy undergoing 1–2 level fusions.
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Intravascular lithotripsy (IVL) is associated with excellent angiographic and short-term results in patients with calcified lesions requiring percutaneous coronary intervention. We conducted a 1-year follow up of a retrospective cohort of 47 patients (61 lesions) who underwent IVL. The primary outcome was target vessel revascularization (TVR) at 1-year from index procedure. Four percent of patients required TVR within 1 year; 96% who underwent IVL remained free from repeat intervention on the same vessel. One patient suffered a myocardial infarction; the culprit vessel had not been previously treated with IVL. IVL is an effective and durable modality for treatment of highly calcified coronary lesions in high-risk patients
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Background: Genetic polymorphism in MMPs are associated with multiple adverse CV events. There is little evidence regarding role of MMPs and their genetic polymorphisms in young (<50 years) STsegment elevation myocardial infarction (STEMI) patients. Methods: This study included 100 young (18e50 years) STEMI patients and 100 healthy controls. Serum levels of MMP-3, MMP-9 and TIMP were estimated for both patients as well as controls. Additionally, genetic polymorphisms in the MMP-9 gene (_x0001_1562 C/T and R279Q) & MMP-3 gene (5A/6A-1612) was evaluated. All these patients were followed up for one year and major adverse cardiac events (MACE) were determined. Results: Serum levels of MMP-3 (128.16 ± 115.81 vs 102.3 ± 57.28 ng/mL; P ¼ 0.04), MMP-9 (469.63 ± 238.4 vs 188.88 ± 94.08 pg/mL; P < 0.0001) and TIMP (5.84 ± 1.93 vs 2.28 ± 1.42 ng/mL; P < 0.0001) were significantly higher in patients as compared to controls. Additionally, patients with genetic polymorphisms in the MMP genes (5A/5A, 6A/6A and the AG genotypes) had an increased risk of STEMI. Patients with MACE had significantly higher levels of MMP-9 (581.73 ± 260.93 vs 438.01 ± 223.38 pg/mL; P ¼ 0.012). A cutoff value of 375.5 pg/mL of MMP-9 was best able to discriminate patients with STEMI and MACE with sensitivity of 77.3% and specificity of 57%. Conclusion: Novel biomarkers such as MMP-3, MMP-9 and TIMP and their genetic polymorphism are associated with the susceptibility for STEMI in young individuals. Higher MMP-9 levels in STEMI patients with MACE suggests its potential role in predicting cardiac remodeling and left ventricular dysfunction
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Introduction :Coronavirus disease 2019(COVID-19) saw an overhaul in the biomedical waste management (BMWM) practices. Waste handlers were at the brunt of these changes. If the challenges pertaining to BMWM at the ground level are better understood, more effective measures to overcome them can be formulated. 1. To identify myths and concerns regarding BMWM in the context of COVID-Objectives: 19 pandemic. 2. To explore the challenges faced in BMWM amidst the COVID-19 pandemic. 3.To explore opportunities and future perspectives of BMWM. In-depth interviews were conducted among 17Method: purposively selected Class IV health care workers during August to November 2021 in a tertiary care institute in Mumbai. Data was reported using thematic analysis. Three major themes - challengesResults: and concerns faced by BMW handlers, enablers/ motivators, opportunities and future practices were generated from the transcripts. Various challenges faced by waste handlers were- difficulties in segregation and transport of BMW, exhaustion from PPE usage and fear of acquiring and spreading COVID-19 from work, stigma faced from public, and handling COVID-19 deaths. Support from family and colleagues, incentives and a positive change in public perception enabled them to work. Forming redressal committees, addressing job security concerns and timely provision of good quality equipment can improve hospital waste management measures in the future. It is of utmost importance to address challenges faced byConclusion: waste handlers in BMWM. Onus should also be on periodic training in BMWM
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Background:There is a need to identify novel markers for CAD, independent of traditional CV risk factors. One of these is gamma?glutamyl transferase (GGT), a marker of increased oxidative stress. Given the high prevalence of CAD in Asian Indians, the link of GGT and CAD in them needs to be studied. Aim: To assess GGT in patients with angiographically documented CAD. Methods and Results: Two hundred patients aged 58.1 ± 9.95 years, 73% males, hypertension 56%, diabetes 40% were included. Mean GGT was 63.6 ± 44.33 (10–269 U/L). The levels of GGT progressively increased in those with single/double or triple?vessel CAD (36.5, 61.5, and 87 U/L, respectively, P < 0.001). Using objective criteria of CAD burden (SYNTAX and Gensini scores), we reaffirmed these findings. GGT in patients with SYNTAX tertiles 0–22, 23–32, and 33 was 33, 62, and 97 U/L, respectively and in Gensini tertiles 0–17.65, 17.66–56.65, ?56.66 was 32, 52, and 88 U/L, respectively, all P < 0.001. SYNTAX score 23 was present in only 23% patients in GGT tertile 1 (<41 U/L), whereas60% and 94% in GGT tertiles 2 and 3 had SYNTAX 23. Significant positive correlation was seen between GGT and SYNTAX (r = 0.634) and Gensini score (r = 0.772). Conclusions: In this study, GGT had an independent correlation with angiographic severity of CAD and SYNTAX and Gensini scores. Although the existing evidence seems biologically plausible, more studies are needed to explore the potential role of this inexpensive marker for predicting disease burden in patients with CAD.
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Purpose: To study the demographic profile, contributing and precipitating factors, the severity of striate keratopathy and its relation with endothelial cell count, and evaluate the final treatment outcome of striate keratopathy. Methods: This observational analytical cohort study was conducted on 75 patients developing striate keratopathy after MSICS in the immediate postoperative period. Demographic profile, preoperative risk factors, and intraoperative complications were evaluated retrospectively. Postoperatively, slit-lamp grading of striate keratopathy was done, and specular microscopy of both eyes was taken. Treatment of striate keratopathy was initiated, and patients were followed up for 6 to 10 weeks for improvement. Results: Striate keratopathy was most commonly associated with surgeries performed by resident surgeons (92%), longer duration of surgery, associated predisposing factors, and intraoperative or postoperative complications. On postoperative day 1, the majority of patients had moderate and severe striate keratopathy (66% and 32%, respectively). It was associated with significant endothelial cell loss (ECL) at the final follow-up (P = 0.0016). Striate keratopathy resolved in 97.3% of patients, irrespective of the treatment with hypertonic saline. At 6 to 10 weeks, 92% of patients achieved a BCVA of ?6/9. Conclusion: A careful preoperative evaluation, adequate training of resident surgeons, meticulous surgical technique, and prompt management of postoperative complications can lead to a decrease in the incidence of striate keratopathy in the majority of cases. The use of hypertonic saline eye drops does not change the final outcome, and most cases resolve spontaneously during follow-up
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Introduction: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) programme states that COPD is a common, treatable, and preventable disease that is characterized by a persistent airflow restriction that usually progresses and is connected to an exaggerated chronic inflammatory response in the airways and the lung to harmful particles or gases. The combined severity of a patient's co-morbid illnesses and exacerbations increases. The purpose of the study was to assess the vitamin D status of COPD patients and healthy participants. Methodology: This case-control study was conducted among 75 cases and 75 control at the Surat Municipal Institute of Medical Education and Research General Medicine department. Result: The mean vitamin D of subjects in cases was 32.21 � 12.68 and it was 52.05 � 1.99 in controls. The difference in vitamin D between the two groups was statistically significant (P Value<0.001). Conclusion: COPD patients had lower amounts of vitamin D. As COPD severity increases, vitamin D levels decrease. Along with a rise in COPD exacerbations, vitamin D levels are also decreasing
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Lipid-lowering therapy plays a crucial role in reducing adverse cardiovascular (CV) events in patients with established atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia. Lifestyle interventions along with high-intensity statin therapy are the first-line management strategy followed by ezetimibe. Only about 20–30% of patients who are on maximally tolerated statins reach recommended low-density lipoprotein cholesterol (LDL-C) goals. Several factors contribute to the problem, including adherence issues, prescription of less than high-intensity statin therapy, and de-escalation of statin dosages, but in patients with very high baseline LDL-C levels, including those with familial hypercholesterolemia and those who are intolerant to statins, it is critical to expand our arsenal of LDL-C-lowering medications. Moreover, in the extreme risk group of patients with an LDL-C goal of ?30 mg/dL according to the Lipid Association of India (LAI) risk stratification algorithm, there is a significant residual risk requiring the addition of non-statin drugs to achieve LAI recommended targets. This makes bempedoic acid a welcome addition to the existing non-statin therapies such as ezetimibe, bile acid sequestrants, and PCSK9 inhibitors. A low frequency of muscle-related side effects, minimal drug interactions, a significant reduction in high-sensitivity C-reactive protein (hsCRP), and a lower incidence of new-onset or worsening diabetes make it a useful adjunct for LDL-C lowering. However, the CV outcomes trial results are still pending. In this LAI consensus document, we discuss the pharmacology, indications, contraindications, advantages, and evidence-based recommendations for the use of bempedoic acid in clinical practice.
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The American Academy of Neurology (AAN) has recently updated its practise advisory on antiseizure medication withdrawal. The recommendations have been formulated for pediatric as well as adult epilepsy, with emphasis on the risk factors for seizure relapse, occurrence of status epilepticus or death on drug withdrawal, and effect on quality of life in both age groups. We herein list the important aspects of the updated recommendations in pediatric epilepsy for the benefit of the general pediatricians. The full update is available at the AAN website.
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Brittle cornea syndrome (BCS) is a genetic connective tissue disorder with discernible ocular features such as blue scleral and thin cornea that predominantly presents in younger children. We herein describe cases of three siblings with BCS, two of whom presented to us with open globe injuries following trivial trauma. Clinical examination of the other eye in both showed diffusely thin corneas and blue sclera. A systemic evaluation revealed sensorineural hearing loss and hyperextensible joints. The third sibling was screened and found to have features concurrent with BCS. This report highlights the challenges faced in the management of ocular injuries and consecutive complications in these patient
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To study and compare the cases of ‘T’-tube drainage and Choledochoduodenostomy done for Common Bile Duct stones. Methods : A prospective study was conducted from October 2019 – September 2021 (24 months including followup period) in patients diagnosed to have Choledocholithiasis in MGM Medical College and Hospital, Kishanganj, Total 50 patients were Included in this study. Those patients in whom CBD stones detected incidentally on investigation like Ultrasonography upper abdomen done for chronic calculus cholecystitis or detected during surgery for cholecystectomy ie, asymptomatic stones were also included in this study. Results : In the cases of our study, most of the patients (62%) didn’t has sludge. Choledochoduodenostomy was more frequently performed when sludge was present (P=0.043), whereas ‘T’-tube drainage was performed when sludge was absent. only 19 cases (38%) had sludge. And also it was present more commonly with larger diameter CBD (P value =0.016). Conclusion : In this study, both the surgical procedures did not produce any mortality. Some patients developed complications. This could be because much of the study population was elderly and most of the complications were noted in patient with acute cholangitis. In both the group, wound infection was noted to be most common complication. All of the patients treated conservatively successfully.
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Background: Overt left ventricular (LV) dysfunction and congestive heart failure are known entities in Takayasu arteritis (TA). Subclinical LV dysfunction may develop in these patients despite normal LV ejection fraction (LVEF). Moreover, effect of treatment of aortic or renal artery narrowing in such patients is unknown. Methods: This study included 15 angiographically confirmed TA patients undergoing aortic and/or renal intervention. A comprehensive clinical, biochemical and echocardiographic (2-dimensional, speckle tracking and tissue doppler imaging) evaluation were done at baseline, 72 h, and six months post intervention. Results: Six patients (40%) had reduced LVEF (<50%) at baseline while rest 9 (60%) patients had reduced global longitudinal strain (GLS) but normal EF. Diastolic filling pattern was abnormal in all the patients. In patients with baseline reduced EF, mean EF improved from 24.62 ± 12.14% to 45.6 ± 9.45% (p ¼ 0.001), E/ e’ ratio decreased from 15.15 ± 3.19 to 10.8 ± 2.56 (p ¼ 0.005) and median NT pro BNP decreased from 1673 pg/ml (970e2401 pg/ml) to 80 pg/ml (40e354 pg/ml) (p ¼ 0.001) at 6 months after interventional procedure. In patients with baseline normal EF, median NT pro BNP decreased from 512 pg/ml (80 e898.5 pg/ml) to 34 pg/ml (29e70.8 pg/ml) (p < 0.01), mean GLS improved from 8.80 ± 0.77% to 16.3 ± 0.78% (p < 0.001) and mean E/e’ decreased from 12.93 ± 2.63 to 7.8 ± 2.73 (p ¼ 0.005) at 6 months follow up. Conclusion: LV dysfunction is common in patients with TA and obstructive lesions in aorta or renal arteries. GLS can be used to assess subclinical systolic dysfunction in these patients. Timely intervention can improve LV dysfunction and can even reverse the subclinical changes