ABSTRACT
BACKGROUND: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD). METHODS: ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups. RESULTS: After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups. CONCLUSIONS: Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD.
Subject(s)
Cardiovascular Diseases , Myocardial Infarction , Renal Insufficiency, Chronic , Humans , Aged , Secondary Prevention , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/drug therapy , Myocardial Infarction/etiology , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Hemorrhage/complications , Aspirin/therapeutic use , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/complicationsABSTRACT
BACKGROUND: Intravenous edetate disodium-based infusions reduced cardiovascular events in a prior clinical trial. The Trial to Assess Chelation Therapy 2 (TACT2) will replicate the initial study design. METHODS: TACT2 is an NIH-sponsored, randomized, 2x2 factorial, double masked, placebo-controlled, multicenter clinical trial testing 40 weekly infusions of a multi-component edetate disodium (disodium ethylenediamine tetra-acetic acid, or Na2EDTA)-based chelation solution and twice daily oral, high-dose multivitamin and mineral supplements in patients with diabetes and a prior myocardial infarction (MI). TACT2 completed enrollment of 1000 subjects in December 2020, and infusions in December 2021. Subjects are followed for 2.5 to 5 years. The primary endpoint is time to first occurrence of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The trial has >;85% power to detect a 30% relative reduction in the primary endpoint. TACT2 also includes a Trace Metals and Biorepository Core Lab, to test whether benefits of treatment, if present, are due to chelation of lead and cadmium from patients. Design features of TACT2 were chosen to replicate selected features of the first TACT, which demonstrated a significant reduction in cardiovascular outcomes in the EDTA chelation arm compared with placebo among patients with a prior MI, with the largest effect in patients with diabetes. RESULTS: Results are expected in 2024. CONCLUSION: TACT2 may provide definitive evidence of the benefit of edetate disodiumbased chelation on cardiovascular outcomes, as well as the clinical importance of longitudinal changes in toxic metal levels of participants.
Subject(s)
Diabetes Mellitus , Myocardial Infarction , Chelating Agents/therapeutic use , Chelation Therapy/methods , Diabetes Mellitus/drug therapy , Double-Blind Method , Edetic Acid/therapeutic use , Humans , Myocardial Infarction/drug therapy , Myocardial Infarction/epidemiology , VitaminsABSTRACT
Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3â¯months prior. Patients will be randomized 1:1 to receiving apixaban 5â¯mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2â¯years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.
Subject(s)
Anticoagulants/therapeutic use , Aortic Valve/surgery , Factor Xa Inhibitors/therapeutic use , Heart Valve Prosthesis , Postoperative Complications/prevention & control , Pyrazoles/therapeutic use , Pyridones/therapeutic use , Randomized Controlled Trials as Topic/methods , Thromboembolism/prevention & control , Thrombosis/prevention & control , Warfarin/therapeutic use , Anticoagulants/adverse effects , Factor Xa Inhibitors/adverse effects , Humans , Multicenter Studies as Topic , Prosthesis Design , Pyrazoles/adverse effects , Pyridones/adverse effects , Treatment Outcome , Warfarin/adverse effectsABSTRACT
AIMS AND OBJECTIVES: To identify whether meaning in life has moderating and mediating effects on the relationship between depression and quality of life in patients with dysphagia. BACKGROUND: Dysphagic patients typically have multidimensional problems, such as depression, which can negatively influence their quality of life. Meaning in life, therefore, can be used as a psychological resource that may enhance quality of life for these patients. DESIGN: A descriptive cross-sectional research design was used. METHODS: Ninety patients with dysphagia were recruited for a survey from eight general and rehabilitation hospitals in Korea. The questionnaires, which included the Korean version of the Swallowing Quality of Life scale developed by Cha, the Center for Epidemiological Studies-Depression Scale developed by Radloff, and the Purpose in Life test developed by Crumbaugh and Maholick, were used for data collection. Descriptive statistics, Hayes' PROCESS macro and Cronbach's alpha were used for data analyses. RESULTS: Meaning in life was found to mediate the relationship between depression and quality of life in patients with dysphagia. However, the index of moderation was not statistically significant, which mean that meaning in life did not moderate the relationship between the patients' depression and quality of life. CONCLUSIONS: Meaning in life had a mediating effect on the relationship between depression and quality of life in patients with dysphagia. Thus, to improve the quality of life of patients with dysphagia, nurses should apply interventions to help them find meaning in life. RELEVANCE TO CLINICAL PRACTICE: Meaning in life can be used as a nursing intervention strategy to improve the quality of life for patients living with dysphagia and depression.
Subject(s)
Deglutition Disorders/psychology , Depression/psychology , Quality of Life , Cross-Sectional Studies , Deglutition Disorders/complications , Deglutition Disorders/nursing , Depression/complications , Depression/nursing , Female , Humans , Male , Middle Aged , Republic of Korea , Surveys and Questionnaires , TranslationsABSTRACT
OBJECTIVES: Although idiopathic pancreatitis is common, the natural history is not well studied, and the best diagnostic approach to both single and multiple attacks remains undefined. METHODS: We prospectively evaluated patients with idiopathic pancreatitis over a 10-year period, and clinical information for each episode was reviewed. Endoscopic ultrasound (EUS) was performed in all patients. Patients with microlithiasis or bile duct stones were referred for cholecystectomy and endoscopic retrograde cholangiopancreatography (ERCP), respectively. For those with a single attack, if EUS was normal or chronic pancreatitis or pancreas divisum was diagnosed, the patient was followed up for recurrence. For those with multiple attacks and a negative EUS, ERCP and sphincter of Oddi manometry with endoscopic therapy as appropriate were recommended. All patients were followed up in the long term to evaluate for recurrent pancreatitis, the primary study end point. RESULTS: Over the study period, 201 patients were identified (80 single attack, 121 multiple attacks; mean age 53 years, range 17-95 years, s.d. 16.3 years; and 53% female). After EUS, 54% of patients with a single attack were categorized as idiopathic, and for multiple attacks sphincter of Oddi dysfunction (SOD) was the most common diagnosis (41%). Long-term follow-up (median 37 months; interquartile range 19-70 months) documented recurrence of pancreatitis in 15 (24%; 95% confidence interval (CI), 15-38%) patients with a single attack and in 48 (49%; 95% CI, 38-62%) patients with multiple attacks. Despite endoscopic therapy, patients with pancreas divisum and SOD had relapse rates of 50% (95% CI, 35 to 68%) and 55% (95% CI, 31 to 82%), respectively. CONCLUSIONS: Following a single idiopathic attack of pancreatitis and a negative EUS examination, relapse was infrequent. Despite endoscopic therapy, patients with multiple attacks, especially those attributed to pancreas divisum and SOD, had high rates of recurrence. EUS may be a useful, minimally invasive tool for the diagnostic evaluation of idiopathic pancreatitis. The study was listed in Clinicaltrials.gov NCT00609726.
Subject(s)
Cholelithiasis/diagnostic imaging , Endosonography , Pancreatitis/diagnostic imaging , Sphincter of Oddi Dysfunction/diagnosis , Adolescent , Adult , Aged , Aged, 80 and over , Cholangiopancreatography, Endoscopic Retrograde , Cholecystectomy , Cholelithiasis/complications , Cholelithiasis/therapy , Cystic Fibrosis/complications , Cystic Fibrosis/diagnosis , Female , Humans , Male , Manometry , Middle Aged , Multivariate Analysis , Pancreatitis/etiology , Pancreatitis, Chronic/diagnostic imaging , Proportional Hazards Models , Prospective Studies , Recurrence , Referral and Consultation , Sphincter of Oddi Dysfunction/complications , Sphincter of Oddi Dysfunction/therapy , Young AdultABSTRACT
OBJECTIVES: Although abdominal pain is a cardinal feature of choledocholithiasis, there has been little formal study of the features of pain in this condition. The objective of this study was to prospectively evaluate the clinical, laboratory, and radiological features of common bile duct stones, focusing on the characteristics of abdominal pain. METHODS: All of the patients evaluated for choledocholithiasis at the time of endoscopic cholangiopancreatography during a 3.5-year period were prospectively interviewed and evaluated. Specific features of abdominal pain were recorded, including pertinent radiographic and laboratory data and endoscopic cholangiopancreatography findings. RESULTS: During the 42-month study period, 61 patients (mean age 55.3 years; 42.6% men) were identified; 31 patients (50.8%) had undergone cholecystectomy. Of the 52 patients who reported pain, abdominal pain was most commonly described as constant (100%), located in the epigastrium alone (65%) or both the epigastrium and the right upper quadrant (25%), occurring at night (44.3%), and radiating to the back (59.6%) with the number of distinct pain episodes before diagnosis ranging from 1 to 20. The median duration of pain was 3 hours and ranged from 20 minutes to 2 days. Associated symptoms of nausea (69.2%) and vomiting (30.7%) were common. No differences in pain characteristics were detected between those with or without a prior cholecystectomy. Liver tests were abnormal in all patients, with serum transaminase values being most elevated. CONCLUSIONS: In our study, choledocholithiasis had a characteristic pattern of constant epigastric pain radiating to the back that was associated with nausea. A prior episode was common. The most common laboratory abnormality was transaminase elevation, and the most common imaging finding was common bile duct dilatation.
Subject(s)
Abdominal Pain/etiology , Choledocholithiasis/diagnosis , Adolescent , Adult , Aged , Aged, 80 and over , Cholangiopancreatography, Endoscopic Retrograde , Common Bile Duct/diagnostic imaging , Dilatation, Pathologic/diagnostic imaging , Female , Humans , Jaundice/etiology , Male , Middle Aged , Nausea/etiology , Prospective Studies , Transaminases/blood , Young AdultABSTRACT
BACKGROUND: Despite proven clinical benefit, there are no studies that have examined the relationship between pancreatic stent caliber and its impact on PEP [post-endoscopic retrograde cholangiopancreatogram (ERCP) pancreatitis] in high-risk patients. AIM: To study the relationship between stent caliber and PEP rates in patients with confirmed sphincter of Oddi dysfunction (SOD). METHODS: A retrospective review was conducted of ERCP's in patients with SOD from 2002 to 2012 from a prospectively maintained, Institutional Review Board approved database. RESULTS: A total of 243/7659 (3.2%) patients underwent 3Fr or 5Fr pancreatic stent placement following sphincterotomy for manometry-proven SOD. Of these, 133 (54.7%) underwent 3Fr stent placement, while 110 (45.3%) underwent 5Fr stent placement. There was no significant difference between the two groups in terms of baseline characteristics, demographics, and previous cholecystectomy. Cannulation and stent placement success rates were 100% in both groups. There was no significant difference in rates of PEP and overall complications, 12% versus 12.7%; P = 0.89 and 13.5% versus 15.5%; P = 0.54, between the 3Fr and 5Fr cohorts, respectively. There were more mild PEP rates recorded in 5Fr group (93% vs 56% P = 0.0549) that was not statistically significant. CONCLUSIONS: There appears to be no relationship between stent characteristics and the risk or severity of PEP in patients with manometrically proven SOD.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Pancreatic Ducts , Pancreatitis/etiology , Sphincter of Oddi Dysfunction/surgery , Stents , Adult , Female , Humans , Male , Middle Aged , Pancreatitis/epidemiology , Pancreatitis/prevention & control , Retrospective Studies , Risk , Severity of Illness Index , Sphincter of Oddi/surgeryABSTRACT
BACKGROUND/AIMS: Abnormal liver chemistry tests are a hallmark of common bile duct (CBD) stones. There is little information, however, on the prevalence of and predictors for normal liver chemistry tests in such patients. METHODS: Over an 11-year period, all patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) at our Center were prospectively identified. Patients in this study were those with CBD stones found at ERCP and where the indication for ERCP was CBD stones seen on imaging studies or when CBD stones were highly suspected based upon clinical presentation and radiographic and laboratory findings. Liver chemistry tests were recorded from those taken at the time of initial presentation as well as the time closest to ERCP. RESULTS: Of a total of 5,133 patients undergoing ERCP during the study period, the indication was suspicion for CBD stones or for radiographically identified CBD stones in 476 and 593, respectively, with 115 patients having both indications. Of these 1184 patients, 765 had CBD stones of whom 541 had liver tests. Of these 541, 29 patients (5.4%) were found to consistently have normal liver chemistry tests. Multivariate analysis identified two factors predictive of normal liver tests including age >55 years and the presence of abdominal pain. CONCLUSIONS: Although rare, liver tests can be normal in patients with CBD stones. Patients most likely to have normal liver tests included older patients and those with abdominal pain.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Choledocholithiasis/diagnosis , Choledocholithiasis/physiopathology , Abdominal Pain/etiology , Choledocholithiasis/complications , Choledocholithiasis/diagnostic imaging , Humans , Liver Function Tests , Logistic Models , Multivariate Analysis , PrevalenceABSTRACT
BACKGROUND: The aim of the present study was to assess the success and outcome of bile duct stent placement without the use of endoscopic biliary sphincterotomy (EBS). PATIENTS AND METHODS: Over a period of 10 years and 9 months, all patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) were prospectively identified. Bile duct stent placement was routinely done without EBS unless additional therapy (stone removal, multiple stenting) was anticipated. RESULTS: Of 5020 patients who underwent ERCP, bile duct stents were placed in 1668 patients. After excluding those requiring additional endoscopic therapy, 1112 patients (89.5%) had ERCP and stent placement without a sphincterotomy and 130 patients (10.5%) had ERCP and stent placement with asphincterotomy. Deployed endoprostheses were self-expandable metallic stents in 15.7% and plastic in 77.5%. Caliber of plastic stents was 10 Fr in 78.9% and <10 Fr in 21.1%. All stents were successfully placed in these 1112 patients without the need for EBS. Comparing patients undergoing bile duct stenting with and without sphincterotomy, no difference was seen in rates of pancreatitis (1.54% vs 2.07%, P > 0.9999). CONCLUSION: Single bile duct stents, both plastic and metal, can be deployed without EBS.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Sphincterotomy, Endoscopic , Stents , Adolescent , Adult , Aged , Aged, 80 and over , Bile Ducts , Child , Cholangiopancreatography, Endoscopic Retrograde/methods , Female , Humans , Male , Middle Aged , Prosthesis Implantation , Young AdultABSTRACT
OBJECTIVE: Patients with diabetes mellitus (DM) and concomitant atherosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events. RESEARCH DESIGN AND METHODS: ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this prespecified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome. RESULTS: Of 15,076 patients, 5,676 (39%) had DM of whom 2,820 (49.7%) were assigned to 81 mg aspirin and 2,856 (50.3%) to 325 mg aspirin. Patients with versus without DM had higher rates of the composite cardiovascular outcome (9.6% vs. 5.9%; P < 0.001) and bleeding events (0.78% vs. 0.50%; P < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs. 10.0%; hazard ratio [HR] 0.98 [95% CI 0.83-1.16]; P = 0.265) or safety outcome (0.87% vs. 0.69%; subdistribution HR 1.25 [95% CI 0.72-2.16]; P = 0.772). CONCLUSIONS: This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population.
Subject(s)
Atherosclerosis , Cardiovascular Diseases , Diabetes Mellitus , Myocardial Infarction , Stroke , Humans , Aspirin/therapeutic use , Cardiovascular Diseases/drug therapy , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/chemically induced , Diabetes Mellitus/drug therapy , Diabetes Mellitus/chemically induced , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Myocardial Infarction/drug therapy , Myocardial Infarction/epidemiology , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Stroke/epidemiologyABSTRACT
PURPOSE: This study aimed to develop and test a structural equation model on social re-adjustment of individuals with stroke based on a literature review and Roy's adaptation model. METHODS: This study involved 321 participants who had a stroke and visited the outpatient department after discharge. The hypothetical model was developed based on Roy's adaptation model and a comprehensive review of previous literature on the topic. The model comprised four exogenous variables (neurological damage, gender [man], age, and social support) and five endogenous variables (activities of daily living, acceptance of disability, depression, rehabilitation motivation, and social re-adjustment). The data were analyzed using SPSS Windows software version 22.0 and AMOS 23.0. RESULTS: Out of 28 research hypotheses, 18 were supported, and they indicated approximately 64% probability of social re-adjustment. Social re-adjustment is directly and significantly affected by age, social support, activities of daily living, and depression. Social re-adjustment is indirectly affected by neurological impairment, gender (men), age, social support, and rehabilitation motivation. CONCLUSION: Continuous assistance and care should be provided for individuals with disabilities caused by sudden neurological damage to facilitate gradual improvement in their social re-adjustment. To enhance social re-adjustment, especially among older adults, newly developed interventions should focus on improving their activities of daily living, preventing depression, and enhancing support from family and healthcare personnel.
Subject(s)
Body Fluids , Stroke , Male , Humans , Aged , Activities of Daily Living , Health Personnel , MotivationABSTRACT
BACKGROUND: Test-to-stay (TTS) is a strategy to limit school exclusion following an exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the use of TTS within universally masked kindergarten through 12th grade (K-12) school settings following household SARS-CoV-2 exposure. METHODS: Three hundred twenty-two participants were enrolled. Serial rapid antigen testing was performed up to 15 days post-exposure. Analysis-eligible participants completed the 15-day testing protocol, tested positive any time during the testing window, or received a negative test on or after day 9. Primary outcomes included within-school tertiary attack rate (TAR) (test positivity among close contacts of positive TTS participants), and school days saved among TTS participants. RESULTS: Seventy-three of 265 analysis-eligible participants tested positive for SARS-CoV-2 (secondary attack rate of 28% [95% CI: 16-63%]). Among 77 within-school close contacts, 2 were positive (TAR = 3% [95% CI: 1-5%]). Participant absences were limited to 338 days, resulting in 82% of 1849 school days saved. IMPLICATIONS FOR SCHOOL HEALTH POLICY, PRACTICE, AND EQUITY: TTS facilitates continued in-person learning and can greatly reduce the number of missed school days. CONCLUSIONS: Within universally masked K-12 schools, TTS is a safe alternative to school exclusion following household SARS-CoV-2 exposure.
Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/diagnosis , Schools , Educational Status , Family CharacteristicsABSTRACT
AIMS AND OBJECTIVES: To investigate how many critically ill patients developed deep vein thrombosis (DVT) during their admission to intensive care units (ICU) and to compare the characteristics of patients with and without deep vein thrombosis. BACKGROUND: Critically ill patients are a high-risk group for deep vein thrombosis because they typically have multiple risk factors, such as prolonged immobility, mechanical ventilation and old age. DESIGN: A prospective observational study was employed. METHODS: The subjects were 90 patients who were older than 18 years of age, who were admitted to an intensive care unit for more than five days and were not provided any prophylactic measures. Data were collected at a university hospital for five months. A duplex scan was performed on day 2.4 on average and repeated between days 5-7 to diagnose deep vein thrombosis. The iliac, femoral, popliteal and tibial veins were examined by compression and colour Doppler methods of the duplex scan by one technician. RESULTS: Age, gender and body mass index were significant factors for deep vein thrombosis development (p < 0.05). Ten patients (11.1%) developed deep vein thrombosis during their stay in the intensive care units. CONCLUSIONS: The incidence was lower than in Western studies in which patients were not provided prophylaxis, but may increase with an extended observation period as in previous studies. RELEVANCE TO CLINICAL PRACTICE: The results of this study could allow ICU nurses to recognise the DVT incidence in critically ill patients. This result could lead to more active prevention and monitoring of DVT by ICU nurses, especially for high-risk patients, such as older or obese patients.
Subject(s)
Critical Illness , Leg/blood supply , Venous Thrombosis/epidemiology , Adult , Aged , Female , Humans , Incidence , Male , Middle Aged , Prospective Studies , Risk FactorsABSTRACT
Health-related quality of life (HRQOL) is a multifactorial concept in assessing physical and mental health. This study was performed to evaluate the HRQOL of patients undergoing coronary artery bypass graft (CABG) surgery and the predictors of HRQOL in patients until 1 year after surgery. This cross-sectional study included 110 consecutive patients who underwent elective CABG in a medical center in South Korea. The Short-Form Health Survey, cardiac symptom survey, cardiac self-efficacy, and the Interpersonal Support Evaluation List-12 were used to measure the HRQOL, symptom experience, self-efficacy, and social support, respectively. The regression model explained 42% of the variance in the participants' physical HRQOL. The predictors of the physical HRQOL include the presence of a spouse, post-CABG duration, symptom experience, and self-efficacy. The regression model explained 36% of the variance in the participants' mental HRQOL. The predictors of the mental HRQOL included perceived health status, self-efficacy, and social support. The predictive factors for HRQOL after CABG were the presence of a spouse, post-CABG duration, symptom experience, self-efficacy, and social support. Furthermore, a suitable program and nursing interventions could be implemented to improve the HRQOL of post-CABG patients.
Subject(s)
Coronary Artery Bypass , Quality of Life , Coronary Artery Bypass/psychology , Cross-Sectional Studies , Health Status , Humans , Quality of Life/psychology , Surveys and QuestionnairesABSTRACT
OBJECTIVES: We evaluated the safety and efficacy of a test-to-stay program for unvaccinated students and staff who experienced an unmasked, in-school exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Serial testing instead of quarantine was offered to asymptomatic contacts. We measured secondary and tertiary transmission rates within participating schools and in-school days preserved for participants. METHODS: Participating staff or students from universally masked districts in North Carolina underwent rapid antigen testing at set intervals up to 7 days after known exposure. Collected data included location or setting of exposure, participant symptoms, and school absences up to 14 days after enrollment. Outcomes included tertiary transmission, secondary transmission, and school days saved among test-to-stay participants. A prespecified interim safety analysis occurred after 1 month of enrollment. RESULTS: We enrolled 367 participants and completed 14-day follow-up on all participants for this analysis. Nearly all (215 of 238, 90%) exposure encounters involved an unmasked index case and an unmasked close contact, with most (353 of 366, 96%) occurring indoors, during lunch (137 of 357, 39%) or athletics (45 of 357, 13%). Secondary attack rate was 1.7% (95% confidence interval: 0.6%-4.7%) based on 883 SARS-CoV-2 serial rapid antigen tests with results from 357 participants; no tertiary cases were identified, and 1628 (92%) school days were saved through test-to-stay program implementation out of 1764 days potentially missed. CONCLUSION: After unmasked in-school exposure to SARS-CoV-2, even in a mostly unvaccinated population, a test-to-stay strategy is a safe alternative to quarantine.
Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , COVID-19 Testing , Humans , Quarantine , SchoolsABSTRACT
OBJECTIVES: We evaluated the impact of a test-to-stay (TTS) program on within-school transmission and missed school days in optionally masked kindergarten through 12th grade schools during a period of high community severe acute respiratory syndrome coronavirus 2 transmission. METHODS: Close contacts of those with confirmed severe acute respiratory syndrome coronavirus 2 infection were eligible for enrollment in the TTS program if exposure to a nonhousehold contact occurred between November 11, 2021 and January 28, 2022. Consented participants avoided school exclusion if they remained asymptomatic and rapid antigen testing at prespecified intervals remained negative. Primary outcomes included within-school tertiary attack rate (test positivity among close contacts of positive TTS participants) and school days saved among TTS participants. We estimated the number of additional school-acquired cases resulting from TTS and eliminating school exclusion. RESULTS: A total of 1675 participants tested positive or received at least 1 negative test between days 5 and 7 and completed follow-up; 92% were students and 91% were exposed to an unmasked primary case. We identified 201 positive cases. We observed a tertiary attack rate of 10% (95% confidence interval: 6%-19%), and 7272 (89%) of potentially missed days were saved through TTS implementation. We estimated 1 additional school-acquired case for every 21 TTS participants remaining in school buildings during the entire study period. CONCLUSIONS: Even in the setting of high community transmission, a TTS strategy resulted in substantial reduction in missed school days in optionally masked schools.
Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/prevention & control , Schools , IncidenceABSTRACT
OBJECTIVE: The aim of this study is (1) to describe the prevalence and correlates of unmet needs among esophageal cancer survivors (ECS) in Korea and (2) to identify the association between unmet needs and health-related quality of life (HRQOL). METHODS: We used a cross-sectional descriptive study design. Participants were 118 ECS from a hospital in Korea who received surgery at least 12 months before participating. We collected data including the Supportive Care Needs Survey-short form 34 and to measure HRQOL, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 with a self-report questionnaire. RESULTS: Participants' mean age was 65.2 years, and 92.4% were male. Among five domains of supportive care needs, unmet need prevalence ranged from 0.8% to 50%. The most commonly reported domains of unmet needs were Health System and Information and Physical and Daily Living. Participants with unmet needs in Psychological Needs, Physical and Daily Living Needs, and Patient Care and Support Needs demonstrated significantly poorer HRQOL in almost all measured domains. CONCLUSIONS: Our finding suggests that Korean ECS had substantial unmet needs, especially in the Health System and Information domain. Psychological, Patient Care and Support, and Physical and Daily Living Needs were related to HRQOL. The study can advance understanding of priority issues in ECS.
ABSTRACT
Hypertension, obesity, chronic kidney disease and type 2 diabetes are comorbidities that have very high prevalence among persons with hyperuricemia (serum urate > 6.8 mg/dL) and gout. Here we use multivariate genetic models to test the hypothesis that the co-association of traits representing hyperuricemia and its comorbidities is genetically based. Using Bayesian whole-genome regression models, we estimated the genetic marker-based variance and the covariance between serum urate, serum creatinine, systolic blood pressure (SBP), blood glucose and body mass index (BMI) from two independent family-based studies: The Framingham Heart Study-FHS and the Hypertension Genetic Epidemiology Network study-HyperGEN. The main genetic findings that replicated in both FHS and HyperGEN, were (1) creatinine was genetically correlated only with urate and (2) BMI was genetically correlated with urate, SBP, and glucose. The environmental covariance among the traits was generally highest for trait pairs involving BMI. The genetic overlap of traits representing the comorbidities of hyperuricemia and gout appears to cluster in two separate axes of genetic covariance. Because creatinine is genetically correlated with urate but not with metabolic traits, this suggests there is one genetic module of shared loci associated with hyperuricemia and chronic kidney disease. Another module of shared loci may account for the association of hyperuricemia and metabolic syndrome. This study provides a clear quantitative genetic basis for the clustering of comorbidities with hyperuricemia.
Subject(s)
Cardiometabolic Risk Factors , Gout/genetics , Hyperuricemia/genetics , Quantitative Trait Loci , Bayes Theorem , Blood Pressure , Comorbidity , Creatinine/blood , Genome-Wide Association Study , Gout/epidemiology , Humans , Hyperuricemia/epidemiology , Uric Acid/bloodABSTRACT
BACKGROUND: The NIH-funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stable patients age ≥50 who were ≥6â¯months post myocardial infarction to 40 infusions of an edetate disodium-based regimen or placebo. In 633 patients with diabetes, edetate disodium significantly reduced the primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.44-0.79, pâ¯<â¯0.001). The principal secondary endpoint of a composite of cardiovascular death, myocardial infarction, or stroke was also reduced (HR 0.60, 95% CI 0.39-0.91, pâ¯=â¯0.017). It is unknown if the treatment effect differs by diabetes therapy. METHODS: We grouped the subset of 633 patients with diabetes according to glucose-lowering therapy at time of randomization. The log-rank test was used to compare active therapy versus placebo. All treatment comparisons were performed using 2-sided significance tests at the significance level of 0.05 and were as randomized. Relative risks were expressed as HR with associated 95% CI, calculated using the Cox proportional hazards model. RESULTS: There were 162 (25.7%) patients treated with insulin; 301 (47.5%) with oral hypoglycemics only; and 170 (26.8%) receiving no pharmacologic treatment for diabetes. Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%) (HR 1.56, 95% CI 1.07-2.27, pâ¯=â¯0.022)] or oral hypoglycemics [61 (38%) vs 87 (29%) (HR 1.46, 1.05-2.03, pâ¯=â¯0.024)]. The primary endpoint occurred less frequently with edetate disodium based therapy versus placebo in patients on insulin [19 (26%) vs 42 (48%) (HR 0.42, 95% CI 0.25-0.74, log-rank pâ¯=â¯0.002)], marginally in patients on oral hypoglycemics [38 (25%) vs 49 (34%) (HR 0.66, 95% CI 0.43-1.01, log-rank pâ¯=â¯0.041)], and no significant difference in patients not treated with a pharmacologic therapy [23 (25%) vs 26 (34%) (HR 0.69, 95% CI 0.39-1.20, log-rank pâ¯=â¯0.225)]. The interaction between randomized intravenous treatment and type of diabetes therapy was not statistically significant (pâ¯=â¯0.203). CONCLUSIONS: Edetate disodium treatment in stable, post-myocardial infarction patients with diabetes suggests that patients on insulin therapy at baseline may accrue the greatest benefit. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov identifier: http://clinicaltrials.gov/ct2/show/NCT00044213?term=TACT&rank=7 identifier Trial to Assess Chelation Therapy (TACT), NCT00044213.