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Trauma Surgery & Acute Care Open 2024Venous thromboembolism (VTE) risk reduction strategies include early initiation of chemoprophylaxis, reducing missed doses, weight-based dosing and dose adjustment using...
OBJECTIVE
Venous thromboembolism (VTE) risk reduction strategies include early initiation of chemoprophylaxis, reducing missed doses, weight-based dosing and dose adjustment using anti-Xa levels. We hypothesized that time to initiation of chemoprophylaxis would be the strongest modifiable risk for VTE, even after adjusting for competing risk factors.
METHODS
A prospectively maintained trauma registry was queried for patients admitted July 2017-October 2021 who were 18 years and older and received emergency release blood products. Patients with deep vein thrombosis or pulmonary embolism (VTE) were compared to those without (no VTE). Door-to-prophylaxis was defined as time from hospital arrival to first dose of VTE chemoprophylaxis (hours). Univariate and multivariate analyses were then performed between the two groups.
RESULTS
2047 patients met inclusion (106 VTE, 1941 no VTE). There were no differences in baseline or demographic data. VTE patients had higher injury severity score (29 vs 24), more evidence of shock by arrival lactate (4.6 vs 3.9) and received more post-ED transfusions (8 vs 2 units); all p<0.05. While there was no difference in need for enoxaparin dose adjustment or missed doses, door-to-prophylaxis time was longer in the VTE group (35 vs 25 hours; p=0.009). On multivariate logistic regression analysis, every hour delay from time of arrival increased likelihood of VTE by 1.5% (OR 1.015, 95% CI 1.004 to 1.023, p=0.004).
CONCLUSION
The current retrospective study of severely injured patients with trauma who required emergency release blood products found that increased door-to-prophylaxis time was significantly associated with an increased likelihood for VTE. Chemoprophylaxis initiation is one of the few modifiable risk factors available to combat VTE, therefore early initiation is paramount. Similar to door-to-balloon time in treating myocardial infarction and door-to-tPA time in stroke, "door-to-prophylaxis time" should be considered as a hospital metric for prevention of VTE in trauma.
LEVEL OF EVIDENCE
Level III, retrospective study with up to two negative criteria.
PubMed: 38666014
DOI: 10.1136/tsaco-2023-001297 -
JMIR Formative Research Apr 2024In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse...
BACKGROUND
In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice.
OBJECTIVE
This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement.
METHODS
A process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians.
RESULTS
Of the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient's health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment.
CONCLUSIONS
This study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their "clinical glance," posing a potential risk of overlooking crucial patients' symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766.
PubMed: 38656781
DOI: 10.2196/48173 -
BMC Primary Care Apr 2024The purpose of this study was to understand the healthcare provider (HCP) perspective on the extent of suboptimal insulin dosing in people with diabetes (PwD), as well...
BACKGROUND
The purpose of this study was to understand the healthcare provider (HCP) perspective on the extent of suboptimal insulin dosing in people with diabetes (PwD), as well as specific challenges and solutions to insulin management.
METHODS
An online survey of general practitioners and specialists (N = 640) who treat PwD in Germany, Spain, the United Kingdom, and the United States was conducted. Responses regarding HCP background and their patients, HCP perceptions of suboptimal insulin use, and challenges associated with optimal insulin use were collected. Categorical summary statistics were presented.
RESULTS
Overall, for type 1 diabetes (T1D) and type 2 diabetes (T2D), most physicians indicated < 30% of PwD missed or skipped a bolus insulin dose in the last 30 days (T1D: 83.0%; T2D: 74.1%). The top 3 reasons (other than skipping a meal) HCPs believed caused the PwD to miss or skip insulin doses included they "forgot," (bolus: 75.0%; basal: 67.5%) "were too busy/distracted," (bolus: 58.8%; basal: 48.3%), and "were out of their normal routine" (bolus: 57.8%; basal: 48.6%). HCPs reported similar reasons that they believed caused PwD to mistime insulin doses. Digital technology and improved HCP-PwD communication were potential solutions identified by HCPs to optimize insulin dosing in PwD.
CONCLUSIONS
Other studies have shown that PwD frequently experience suboptimal insulin dosing. Conversely, results from this study showed that HCPs believe suboptimal insulin dosing among PwD is limited in frequency. While no direct comparisons were made in this study, this apparent discrepancy could lead to difficulties in HCPs giving PwD the best advice on optimal insulin management. Approaches such as improving the objectivity of dose measurements for both PwD and HCPs may improve associated communications and help reduce suboptimal insulin dosing, thus enhancing treatment outcomes.
Topics: Humans; Diabetes Mellitus, Type 1; Insulin; Diabetes Mellitus, Type 2; Cross-Sectional Studies; Hypoglycemic Agents; Male; Female; Middle Aged; Adult; Practice Patterns, Physicians'; Surveys and Questionnaires; Health Personnel; Attitude of Health Personnel
PubMed: 38649812
DOI: 10.1186/s12875-024-02390-9 -
Trials Apr 2024The World Health Organization recommends universal iron supplementation for children aged 6-23 months in countries where anaemia is seen in over 40% of the population....
BACKGROUND
The World Health Organization recommends universal iron supplementation for children aged 6-23 months in countries where anaemia is seen in over 40% of the population. Conventional ferrous salts have low efficacy due to low oral absorption in children with inflammation. Haem iron is more bioavailable, and its absorption may not be decreased by inflammation. This study aims to compare daily supplementation with haem iron versus ferrous sulphate on haemoglobin concentration and serum ferritin concentration after 12 weeks of supplementation.
METHODS
This will be a two-arm, randomised controlled trial. Gambian children aged 6-12 months with anaemia will be recruited within a predefined geographical area and recruited by trained field workers. Eligible participants will be individually randomised using a 1:1 ratio within permuted blocks to daily supplementation for 12 weeks with either 10.0 mg of elemental iron as haem or ferrous sulphate. Safety outcomes such as diarrhoea and infection-related adverse events will be assessed daily by the clinical team (see Bah et al. Additional file 4_Adverse event eCRF). Linear regression will be used to analyse continuous outcomes, with log transformation to normalise residuals as needed. Binary outcomes will be analysed by binomial regression or logistic regression, Primary analysis will be by modified intention-to-treat (i.e., those randomised and who ingested at least one supplement dose of iron), with multiple imputations to replace missing data. Effect estimates will be adjusted for baseline covariates (C-reactive protein, alpha-1-acid glycoprotein, haemoglobin, ferritin, soluble transferrin receptor).
DISCUSSION
This study will determine if therapeutic supplementation with haem iron is more efficacious than with conventional ferrous sulphate in enhancing haemoglobin and ferritin concentrations in anaemic children aged 6-12 months.
TRIAL REGISTRATION
Pan African Clinical Trial Registry PACTR202210523178727.
Topics: Child; Humans; Iron; Anemia, Iron-Deficiency; Salts; Gambia; Ferrous Compounds; Ferritins; Anemia; Hemoglobins; Dietary Supplements; Inflammation; Heme; Randomized Controlled Trials as Topic
PubMed: 38641845
DOI: 10.1186/s13063-024-08101-0 -
Health Science Reports Apr 2024Due to the concern about the side effects of chemical drugs and their ineffectiveness, the use of natural compounds as alternatives or complementary therapies has...
BACKGROUND AND AIM
Due to the concern about the side effects of chemical drugs and their ineffectiveness, the use of natural compounds as alternatives or complementary therapies has received increasing attention. The purpose of this study was to investigate the effect of oil on the outcome of missed abortion.
METHODS
In this double-blind clinical trial, 70 nulliparous pregnant women referred to Hajar Hospital and Imam Ali clinics of Shahrekord and had missed abortion before the 12-week gestational age were selected and randomly divided into two interventions and control groups. The intervention group received 5 g of oil alone daily for up to 3 days and the control group received a placebo. In case of nonresponse, 3 days after the last dose of medication or placebo, 800 μg of misoprostol (vaginal) were used. Data were analyzed by SPSS software. The chi-square test, Fisher's exact test, independent -test and paired -test were used for analytical statistics.
RESULTS
According to the results, 18 cases (51.4%) in the intervention group and seven cases (20%) in the control group showed complete evacuation of uterine contents which had a significant difference ( < 0.05). The frequency of vagina physical examination and type of hemorrhage did not show any significant difference between the two groups before and after the intervention. After the intervention, human chorionic gonadotropin (HCG) was significantly decreased in the intervention group but did not change in the control group ( < 0.05). The frequency of adverse events in the intervention group was three (8.6%) and in the control group was one (2.9%) which had no significant difference.
CONCLUSION
improves the outcome of missed abortion by reducing HCG and facilitating cervix dilatation and delivery of uterine contents.
PubMed: 38633734
DOI: 10.1002/hsr2.2029 -
Journal of Clinical Medicine Mar 2024Acute coronary syndromes (ACS), encompassing conditions like ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndromes (NSTE-ACS),... (Review)
Review
The Evolving Field of Acute Coronary Syndrome Management: A Critical Appraisal of the 2023 European Society of Cardiology Guidelines for the Management of Acute Coronary Syndrome.
Acute coronary syndromes (ACS), encompassing conditions like ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndromes (NSTE-ACS), represent a significant challenge in cardiovascular care due to their complex pathophysiology and substantial impact on morbidity and mortality. The 2023 European Society of Cardiology (ESC) guidelines for ACS management introduce several updates in key areas such as invasive treatment timing in NSTE-ACS, pre-treatment strategies, approaches to multivessel disease, and the use of imaging modalities including computed tomography (CT) coronary angiography, magnetic resonance imaging (MRI), and intracoronary imaging techniques, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS). They also address a modulation of antiplatelet therapy, taking into consideration different patient risk profiles, and introduce new recommendations for low-dose colchicine. These guidelines provide important evidence-based updates in practice, reflecting an evolution in the understanding and management of ACS, yet some potentially missed opportunities for more personalized care and technology adoption are discussed.
PubMed: 38610650
DOI: 10.3390/jcm13071885 -
Clinical Medicine & Research Mar 2024The anti-inflammatory and immunosuppressive properties of steroids allow their use in a wide variety of rheumatological diseases, asthma, inflammatory bowel disease,...
The anti-inflammatory and immunosuppressive properties of steroids allow their use in a wide variety of rheumatological diseases, asthma, inflammatory bowel disease, cancer therapy, and severe viral infections. Though life-saving or organ-saving, long-term clinical use leads to a vast array of complications. Osteoporosis is the most common orthopedic side effect of steroid abuse, while osteonecrosis is a rare occurrence. The risk of osteonecrosis appears to be dose and duration dependent, but several patient factors also play a major role and usually affect the femoral head followed by the knee joint. The long-term effects of steroids must be explained to all patients on therapy, but this risk is missed in individuals who abuse steroids for recreational or performance-enhancing purposes. We describe a male, aged 29 years, who presented with dull aching bilateral knee pain of 2-years' duration after a long-term steroid abuse for weight and muscle mass gain. Radiological and magnetic resonance imaging studies confirmed osteonecrosis of femoral and tibial condyles and secondary degenerative arthritis of the knee joint. Prompt suspicion, early diagnosis, and intervention in osteonecrosis of knee joints, and termination of steroids may reverse the pathology and prevent progression of disease.
Topics: Humans; Male; Knee Joint; Tibia; Femur; Osteonecrosis; Pain; Steroids
PubMed: 38609146
DOI: 10.3121/cmr.2024.1855 -
Cureus Mar 2024Although acute pancreatitis has been reported as an adverse event in patients treated with glucagon-like peptide-1 (GLP-1) analogues, to date we have not identified a...
Although acute pancreatitis has been reported as an adverse event in patients treated with glucagon-like peptide-1 (GLP-1) analogues, to date we have not identified a case describing exocrine pancreatic insufficiency related to this drug. Here we present a case of a patient with no history of acute pancreatitis, who was diagnosed with exocrine pancreatic insufficiency during the third year of weekly subcutaneous semaglutide for obesity control. A 68-year-old man with previous unsuccessful therapeutic approaches for weight loss used subcutaneous semaglutide, once a week, for 181 weeks. The pharmacological treatment, combined with instructions on lifestyle changes, resulted in a weight loss of 11.6% of initial body weight, with a reduction in body mass index from 35.7 to 31.9 kg/m. The patient received a regular dose of 0.5mg/week in the first 14 weeks in a private physician's office. During this period, an asymptomatic elevation of serum lipase was identified and attributed to alcohol consumption. Because the patient complained of less satiety and weight loss stabilization, the dose of semaglutide was increased to 1.0mg/week. Serum lipase levels increased to up to eight times the upper normal limit and the use of semaglutide was discontinued for 10 weeks. Due to progressive weight regain and serum lipase levels being near normal, semaglutide was reintroduced at 0.25mg/week with progressive increments until 1.0mg/week. The patient missed the follow-up appointments, continued the same dose of semaglutide for another 16 weeks, and discontinued treatment after another asymptomatic elevation in serum lipase levels. Four weeks later, the patient reported steatorrhea and was seen by a gastroenterologist, who diagnosed exocrine pancreatic insufficiency. The course of our case suggests a potential association between semaglutide and chronic alcohol consumption in the development of exogenous pancreatic insufficiency. We call attention to the importance of regular monitoring of serum lipase levels in patients taking GLP-1 analogues and suggest that the consumption of any amount of alcohol should be discouraged in patients in long-term treatment with glucagon-like peptide-1 receptor agonists.
PubMed: 38576650
DOI: 10.7759/cureus.55549 -
Diabetes Care Jun 2024To evaluate the association of insulin injection adherence, smart insulin pen engagement, and glycemic control using real-world data from 16 countries from adults...
OBJECTIVE
To evaluate the association of insulin injection adherence, smart insulin pen engagement, and glycemic control using real-world data from 16 countries from adults self-administering basal insulin degludec and bolus insulin with a smart insulin pen (NovoPen 6 or NovoPen Echo Plus) alongside continuous glucose monitoring (CGM).
RESEARCH DESIGN AND METHODS
Data were aggregated over 14-day periods. Treatment adherence was defined according to the number of missed basal and missed bolus insulin doses and smart pen engagement according to the number of days with data uploads.
RESULTS
Data from 3,945 adults, including 25,157 14-day periods with ≥70% CGM coverage, were analyzed. On average, 0.2 basal and 6.0 bolus insulin doses were missed over 14 days. The estimated probability of missing at least one basal insulin dose over a 14-day period was 17.6% (95% CI 16.5, 18.7). Missing one basal or bolus insulin dose per 14 days was associated with a significant decrease in percentage of time with glucose levels in range (TIR) (3.9-10.0 mmol/L), of -2.8% (95% CI -3.7, -1.8) and -1.7% (-1.8, -1.6), respectively; therefore, missing two basal or four bolus doses would decrease TIR by >5%. Smart pen engagement was associated positively with glycemic outcomes.
CONCLUSIONS
This combined analysis of real-world smart pen and CGM data showed that missing two basal or four bolus insulin doses over a 14-day period would be associated with a clinically relevant decrease in TIR. Smart insulin pens provide valuable insights into treatment injection behaviors.
Topics: Humans; Male; Female; Middle Aged; Insulin; Blood Glucose Self-Monitoring; Blood Glucose; Hypoglycemic Agents; Adult; Aged; Treatment Adherence and Compliance; Insulin, Long-Acting; Diabetes Mellitus; Diabetes Mellitus, Type 1; Continuous Glucose Monitoring
PubMed: 38569055
DOI: 10.2337/dc23-2176 -
Vaccines Feb 2024: The risk of COVID-19 increases in any occupation entailing intense social interactions. This study aimed to investigate the impact of COVID-19 among civil servants of...
COVID-19 in City Council Civil Servants, 1 March 2020-31 January 2023: Risk of Infection, Reinfection, Vaccine Effectiveness and the Impact of Heterologous Triple Vaccination.
: The risk of COVID-19 increases in any occupation entailing intense social interactions. This study aimed to investigate the impact of COVID-19 among civil servants of Trieste city council (northeastern Italy) over the entire pandemic. : The crude incidence rate of COVID-19 was estimated from 1 March 2020 to 31 January 2023 by explanatory factors, expressing the estimate as COVID-19 events x 10,000 person-days (P-d) at risk. A multivariable Cox proportional hazard regression model was fitted to examine the risk of primary COVID-19 infection and reinfections, reporting adjusted hazard ratios (aHR) with 95% confidence interval (95% CI). : The cohort of Trieste city council was mainly composed of administrative clerks (48.5%), nursery teachers (33%), technicians (9.9%) and local police officers (8.5%). Between 1 March 2020 and 31 January 2023, 1444 (62.4%) employees tested positive for SARS-CoV-2 at least once and 18.1% (=262/1444) at least twice. By the end of this study, 55% (N = 1272) of employees had received at least three doses of COVID-19 vaccine, whereas 19.7% (N = 457) remained unvaccinated. At multiple Cox regression analysis, the adjusted risk of primary COVID-19 events during the entire study period increased in employees aged 40-49 years (aHR = 1.65; 95% CI: 1.01; 2.71), females (aHR = 1.28; 95%CI: 1.12; 1.45), local police officers (aHR = 1.82; 95%CI: 1.50; 2.22) and nursery teachers (aHR = 1.27; 95%CI: 1.13; 1.43). However, whilst the risk of primary infections in police officers increased already during the Alpha transmission period (aHR = 6.82; 95%CI: 4.48; 10.40), progressively reducing across subsequent variants, for nursery teachers, it increased during the Delta wave (aHR = 2.42; 1.70; 3.44), reducing with Omicron (aHR = 1.23; 95%CI: 1.07; 1.40). Compared to unvaccinated colleagues, during the entire study period the risk of primary infections was significantly lower in employees immunized with three (aHR = 0.42; 95%CI: 0.36; 0.47) or four (aHR = 0.30; 95%CI: 0.23; 0.40) doses of COVID-19 vaccine, for a vaccine effectiveness (VE) of 58% and 70%, respectively. The protective effect of vaccination against primary infections was confirmed in the sub-group analysis by main pandemic waves, for a VE of 75% for one dose against 99% for two doses during the Alpha transmission period, slightly reducing to 59% and 70% in Delta time, respectively. During the Omicron wave, the risk of primary SARS-CoV-2 infections diminished significantly with three (aHR = 0.42; 95%CI: 0.36; 0.49) or four vaccine doses (aHR = 0.09; 95%CI: 0.05; 0.16), for a VE of 58% and 91%, respectively. Moreover, the risk of primary SARS-CoV-2 reinfections during the entire study period reduced with one (aHR = 0.47; 95%CI: 0.27; 0.82), two (aHR = 0.42; 95%CI: 0.30; 0.58), three (aHR = 0.32; 95%CI: 0.24; 0.44) or four vaccine doses (aHR = 0.14; 95%CI: 0.05; 0.46), for a VE of 53%, 58%, 68% and 86% against reinfections, respectively. No significant difference in VE was associated with heterologous versus homologous triple vaccination, both against primary infections or reinfections. : Primary SARS-CoV-2 infections were more likely among nursery teachers and local police officers. The risk of both primary infections and reinfections reduced with higher number of doses of COVID-19 vaccine, regardless of the pandemic wave. Since city council civil servants were swab tested on demand or for contact tracing, the estimation of COVID-19 risk and VE largely missed aymptomatic SARS-CoV-2 infections. On the one hand, the present study confirmed the protective effect of COVID-19 vaccination against symptomatic SARS-CoV-2 infections; on the other hand, it highlighted not only the importance of continuous booster doses to keep up the humoral immunity over time but also the importance of updated vaccine formulations to prevent and control the spread of a highly mutable virus. Moreover, the protective effect of the first two doses against reinfections confirmed the efficacy of hybrid immunity during Omicron time.
PubMed: 38543888
DOI: 10.3390/vaccines12030254