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1.
JAMA Netw Open ; 7(5): e2410288, 2024 May 01.
Article En | MEDLINE | ID: mdl-38717772

Importance: Currently, mortality risk for patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) with an uncomplicated postprocedure course is low. Less is known regarding the risk of in-hospital ventricular tachycardia (VT) and ventricular fibrillation (VF). Objective: To evaluate the risk of late VT and VF after primary PCI for STEMI. Design, Setting, and Participants: This cohort study included adults aged 18 years or older with STEMI treated with primary PCI between January 1, 2015, and December 31, 2018, identified in the US National Cardiovascular Data Registry Chest Pain-MI Registry. Data were analyzed from April to December 2020. Main Outcomes and Measures: Multivariable logistic regression was used to evaluate the risk of late VT (≥7 beat run of VT during STEMI hospitalization ≥1 day after PCI) or VF (any episode of VF≥1 day after PCI) associated with cardiac arrest and associations between late VT or VF and in-hospital mortality in the overall cohort and a cohort with uncomplicated STEMI without prior myocardial infarction or heart failure, systolic blood pressure less than 90 mm Hg, cardiogenic shock, cardiac arrest, reinfarction, or left ventricular ejection fraction (LVEF) less than 40%. Results: A total of 174 126 eligible patients with STEMI were treated with primary PCI at 814 sites in the study; 15 460 (8.9%) had VT or VF after primary PCI, and 4156 (2.4%) had late VT or VF. Among the eligible patients, 99 905 (57.4%) at 807 sites had uncomplicated STEMI. The median age for patients with late VT or VF overall was 63 years (IQR, 55-73 years), and 75.5% were men; the median age for patients with late VT or VF with uncomplicated STEMI was 60 years (IQR, 53-69 years), and 77.7% were men. The median length of stay was 3 days (IQR, 2-7 days) for the overall cohort with late VT or VF and 3 days (IQR, 2-4 days) for the cohort with uncomplicated STEMI with late VT or VF. The risk of late VT or VF was 2.4% (overall) and 1.7% (uncomplicated STEMI). Late VT or VF with cardiac arrest occurred in 674 patients overall (0.4%) and in 117 with uncomplicated STEMI (0.1%). LVEF was the most significant factor associated with late VT or VF with cardiac arrest (adjusted odds ratio [AOR] for every 5-unit decrease ≤40%: 1.67; 95% CI, 1.54-1.85). Late VT or VF events were associated with increased odds of in-hospital mortality in the overall cohort (AOR, 6.40; 95% CI, 5.63-7.29) and the cohort with uncomplicated STEMI (AOR, 8.74; 95% CI, 6.53-11.70). Conclusions and Relevance: In this study, a small proportion of patients with STEMI treated with primary PCI had late VT or VF. However, late VT or VF with cardiac arrest was rare, particularly in the cohort with uncomplicated STEMI. This information may be useful when determining the optimal timing for hospital discharge after STEMI.


Hospital Mortality , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Tachycardia, Ventricular , Ventricular Fibrillation , Humans , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/statistics & numerical data , ST Elevation Myocardial Infarction/mortality , ST Elevation Myocardial Infarction/therapy , ST Elevation Myocardial Infarction/surgery , ST Elevation Myocardial Infarction/complications , Male , Female , Middle Aged , Aged , Tachycardia, Ventricular/therapy , Tachycardia, Ventricular/mortality , Tachycardia, Ventricular/etiology , Ventricular Fibrillation/therapy , Ventricular Fibrillation/mortality , Cohort Studies , Registries , Risk Factors
2.
J Glob Health ; 14: 04098, 2024 May 10.
Article En | MEDLINE | ID: mdl-38721686

Background: Emergency obstetric and newborn care (EmONC) in Bangladesh focusses on maternal health, whereby it addresses childbirth and postpartum complications to ensure women's health and well-being. It was transitioned to a digital platform to overcome challenges with the paper-based EmONC register and we conducted implementation research to assess the outcome. Here we outline the stakeholder engagement process integral to the implementation research process. Methods: We adopted a four-step stakeholder engagement model based on the identification, sensitisation, involvement, and engagement of stakeholders. The approach was informed by previous experience, desk reviews, and expert consultations to ensure comprehensive engagement with stakeholders at multiple levels. Led by the Maternal Health Programme of the Government of Bangladesh, we involved high-power and high-interest stakeholders in developing a joint action plan for digitisation of the paper-based EmONC register. Finally, we demonstrated this digital EmONC register in real-life settings to stakeholders at different levels. Results: The successful demonstration process fostered government ownership and collaboration with multiple stakeholders, while laying the foundation for scalability and sustainability. Nevertheless, our experience highlighted that the stakeholder engagement process is context-driven, time-consuming, resource-intensive, iterative, and dynamic, and it requires involving stakeholders with varied expertise. Effective strategic planning, facilitation, and the allocation of sufficient time and resources are essential components for successful stakeholder engagement. Conclusions: Our experience demonstrates the potential of adopting the 'identification, sensitisation, involvement, and engagement' stakeholder engagement model. Success in implementing this model in diverse settings depends on leveraging knowledge gained during implementation, maintaining robust communication with stakeholders, and harnessing the patience and determination of the facilitating organisation.


Stakeholder Participation , Humans , Bangladesh , Female , Pregnancy , Infant, Newborn , Maternal Health Services/organization & administration , Registries , Emergency Medical Services/organization & administration
3.
BMC Med Inform Decis Mak ; 24(1): 121, 2024 May 09.
Article En | MEDLINE | ID: mdl-38724966

OBJECTIVE: Hospitals and healthcare providers should assess and compare the quality of care given to patients and based on this improve the care. In the Netherlands, hospitals provide data to national quality registries, which in return provide annual quality indicators. However, this process is time-consuming, resource intensive and risks patient privacy and confidentiality. In this paper, we presented a multicentric 'Proof of Principle' study for federated calculation of quality indicators in patients with colorectal cancer. The findings suggest that the proposed approach is highly time-efficient and consume significantly lesser resources. MATERIALS AND METHODS: Two quality indicators are calculated in an efficient and privacy presevering federated manner, by i) applying the Findable Accessible Interoperable and Reusable (FAIR) data principles and ii) using the Personal Health Train (PHT) infrastructure. Instead of sharing data to a centralized registry, PHT enables analysis by sending algorithms and sharing only insights from the data. RESULTS: ETL process extracted data from the Electronic Health Record systems of the hospitals, converted them to FAIR data and hosted in RDF endpoints within each hospital. Finally, quality indicators from each center are calculated using PHT and the mean result along with the individual results plotted. DISCUSSION AND CONCLUSION: PHT and FAIR data principles can efficiently calculate quality indicators in a privacy-preserving federated approach and the work can be scaled up both nationally and internationally. Despite this, application of the methodology was largely hampered by ELSI issues. However, the lessons learned from this study can provide other hospitals and researchers to adapt to the process easily and take effective measures in building quality of care infrastructures.


Colorectal Neoplasms , Electronic Health Records , Quality Indicators, Health Care , Humans , Colorectal Neoplasms/therapy , Quality Indicators, Health Care/standards , Netherlands , Electronic Health Records/standards , Registries/standards
4.
PLoS One ; 19(5): e0303182, 2024.
Article En | MEDLINE | ID: mdl-38728338

The objective of this study is to determine the possible association between exposure to air pollution and the risk of death from cancer during childhood in upper northern Thailand. Data were collected on children aged 0-15 years old diagnosed with cancer between January 2003 and December 2018 from the Chiang Mai Cancer Registry. Survival rates were determined by using Kaplan-Meier curves. Cox proportional hazard models were used to investigate associations of potential risk factors with the time-varying air pollution level on the risk of death. Of the 540 children with hematologic cancer, 199 died from any cause (overall mortality rate = 5.3 per 100 Person-Years of Follow-Up (PYFU); 95%CI = 4.6-6.0). Those aged less than one year old (adjusted hazard ratio [aHR] = 2.07; 95%CI = 1.25-3.45) or ten years old or more (aHR = 1.41; 95%CI = 1.04-1.91) at the time of diagnosis had a higher risk of death than those aged one to ten years old. Those diagnosed between 2003 and 2013 had an increased risk of death (aHR = 1.65; 95%CI = 1.13-2.42). Of the 499 children with solid tumors, 214 died from any cause (5.9 per 100 PYFU; 95%CI = 5.1-6.7). Only the cancer stage remained in the final model, with the metastatic cancer stage (HR = 2.26; 95%CI = 1.60-3.21) and the regional cancer stage (HR = 1.53; 95%CI = 1.07-2.19) both associated with an increased risk of death. No association was found between air pollution exposure and all-cause mortality for either type of cancer. A larger-scale analytical study might uncover such relationships.


Air Pollution , Neoplasms , Humans , Thailand/epidemiology , Child , Child, Preschool , Infant , Male , Female , Air Pollution/adverse effects , Air Pollution/analysis , Adolescent , Neoplasms/mortality , Neoplasms/epidemiology , Infant, Newborn , Risk Factors , Registries , Environmental Exposure/adverse effects , Proportional Hazards Models , Survival Rate , Kaplan-Meier Estimate
5.
Medicine (Baltimore) ; 103(19): e38070, 2024 May 10.
Article En | MEDLINE | ID: mdl-38728490

This study used demographic data in a novel prediction model to identify areas with high risk of out-of-hospital cardiac arrest (OHCA) in order to target prehospital preparedness. We combined data from the nationwide Danish Cardiac Arrest Registry with geographical- and demographic data on a hectare level. Hectares were classified in a hierarchy according to characteristics and pooled to square kilometers (km2). Historical OHCA incidence of each hectare group was supplemented with a predicted annual risk of at least 1 OHCA to ensure future applicability. We recorded 19,090 valid OHCAs during 2016 to 2019. The mean annual OHCA rate was highest in residential areas with no point of public interest and 100 to 1000 residents per hectare (9.7/year/km2) followed by pedestrian streets with multiple shops (5.8/year/km2), areas with no point of public interest and 50 to 100 residents (5.5/year/km2), and malls with a mean annual incidence per km2 of 4.6. Other high incidence areas were public transport stations, schools and areas without a point of public interest and 10 to 50 residents. These areas combined constitute 1496 km2 annually corresponding to 3.4% of the total area of Denmark and account for 65% of the OHCA incidence. Our prediction model confirms these areas to be of high risk and outperforms simple previous incidence in identifying future risk-sites. Two thirds of out-of-hospital cardiac arrests were identified in only 3.4% of the area of Denmark. This area was easily identified as having multiple residents or having airports, malls, pedestrian shopping streets or schools. This result has important implications for targeted intervention such as automatic defibrillators available to the public. Further, demographic information should be considered when implementing such interventions.


Out-of-Hospital Cardiac Arrest , Humans , Out-of-Hospital Cardiac Arrest/epidemiology , Male , Female , Denmark/epidemiology , Aged , Middle Aged , Incidence , Registries , Adult , Forecasting , Aged, 80 and over
6.
EuroIntervention ; 20(9): 579-590, 2024 May 10.
Article En | MEDLINE | ID: mdl-38726714

BACKGROUND: Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce. AIMS: We aimed to assess the clinical outcomes, including valve performance, of the S3UR. METHODS: Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort. RESULTS: The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial: 87.0% vs 78.5%, mild: 12.5% vs 20.5%, ≥moderate: 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none: 94.3% vs 85.1%, moderate: 5.2% vs 12.8%, severe: 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group). CONCLUSIONS: The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.


Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis , Registries , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , Female , Male , Aged, 80 and over , Aged , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/physiopathology , Treatment Outcome , Aortic Valve/surgery , Aortic Valve/physiopathology , Aortic Valve/diagnostic imaging , Prosthesis Design , Hemodynamics , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Hospital Mortality
7.
Langenbecks Arch Surg ; 409(1): 156, 2024 May 10.
Article En | MEDLINE | ID: mdl-38730065

INTRODUCTION: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the two most performed techniques in bariatric surgery. The aim of this study is to compare two surgical procedures in terms of weight loss and the development of comorbidities such as type II diabetes mellitus T2D, arterial hypertension, sleep apnea (OSAS), and gastroesophageal reflux disease (GERD). METHODS: Data from the German Bariatric Surgery Registry (GBSR) from 2005 to 2021 were used. 1,392 RYGB and 1,132 SG primary surgery patients were included. Minimum age 18 years; five-year follow-up data available. Tests were performed with a 5% significance level. RESULTS: Loss of follow-up 95.41% within five years. Five years after surgery, the RYGB showed significant advantages in terms of excess weight loss (%EWL 64.2% vs. 56.9%) and remission rates of the studied comorbidities: hypertension (54.4% vs. 47.8%), OSAS (64.5% vs. 50.1%), and GERD (86.1% vs. 66.9%). Compared to the pre-test, individuals diagnosed with insulin-dependent T2D showed significant improvements with RYGB over a five-year period (remission rate: 75% vs. 63%). In contrast, non-insulin-dependent T2D showed no significant difference between the two approaches (p = 0.125). CONCLUSION: Both surgical procedures resulted in significant weight loss and improved comorbidities. However, the improvement in comorbidities was significantly greater in patients who underwent RYGB than in those who underwent SG, suggesting that the RYGB technique is preferable. Nevertheless, RYGB requires a high degree of surgical skill. Therefore, acquiring expertise in the technical facets of the surgery is essential to achieving favorable outcomes.


Gastrectomy , Gastric Bypass , Obesity, Morbid , Weight Loss , Humans , Obesity, Morbid/surgery , Male , Gastric Bypass/methods , Gastric Bypass/adverse effects , Gastrectomy/methods , Gastrectomy/adverse effects , Female , Adult , Middle Aged , Diabetes Mellitus, Type 2/surgery , Diabetes Mellitus, Type 2/complications , Treatment Outcome , Registries , Germany , Retrospective Studies
8.
Scand J Trauma Resusc Emerg Med ; 32(1): 42, 2024 May 10.
Article En | MEDLINE | ID: mdl-38730480

BACKGROUND: Current guidelines from Scandinavian Neuro Committee mandate a 24-hour observation for head trauma patients on anticoagulants, even with normal initial head CT scans, as a means not to miss delayed intracranial hemorrhages. This study aimed to assess the prevalence, and time to diagnosis, of clinically relevant delayed intracranial hemorrhage in head trauma patients treated with oral anticoagulants. METHOD: Utilizing comprehensive two-year data from Region Skåne's emergency departments, which serve a population of 1.3 million inhabitants, this study focused on adult head trauma patients prescribed oral anticoagulants. We identified those with intracranial hemorrhage within 30 days, defining delayed intracranial hemorrhage as a bleeding not apparent on their initial CT head scan. These cases were further defined as clinically relevant if associated with mortality, any intensive care unit admission, or neurosurgery. RESULTS: Out of the included 2,362 head injury cases (median age 84, 56% on a direct acting oral anticoagulant), five developed delayed intracranial hemorrhages. None of these five cases underwent neurosurgery nor were admitted to an intensive care unit. Only two cases (0.08%, 95% confidence interval [0.01-0.3%]) were classified as clinically relevant, involving subdural hematomas in patients aged 82 and 87 years, who both subsequently died. The diagnosis of these delayed intracranial hemorrhages was made at 4 and 7 days following initial presentation to the emergency department. CONCLUSION: In patients with head trauma, on oral anticoagulation, the incidence of clinically relevant delayed intracranial hemorrhage was found to be less than one in a thousand, with detection occurring four days or later after initial presentation. This challenges the effectiveness of the 24-hour observation period recommended by the Scandinavian Neurotrauma Committee guidelines, suggesting a need to reassess these guidelines to optimise care and resource allocation. TRIAL REGISTRATION: This is a retrospective cohort study, does not include any intervention, and has therefore not been registered.


Anticoagulants , Craniocerebral Trauma , Intracranial Hemorrhages , Humans , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Female , Retrospective Studies , Male , Aged, 80 and over , Intracranial Hemorrhages/epidemiology , Intracranial Hemorrhages/chemically induced , Craniocerebral Trauma/complications , Aged , Prevalence , Administration, Oral , Registries , Tomography, X-Ray Computed/methods , Sweden/epidemiology , Middle Aged , Time Factors , Emergency Service, Hospital
9.
Kardiologiia ; 64(4): 3-13, 2024 Apr 30.
Article Ru, En | MEDLINE | ID: mdl-38742510

AIM: Based on data from the Russian REGION-MI registry, to characterize patients with myocardial infarction (MI) hospitalized in Russian hospitals, describe their historical, demographic, and clinical characteristics, and compare the results with the data of previous Russian and international registries of acute coronary syndrome. MATERIAL AND METHODS: REGION-MI is a multicenter prospective observational study. The follow-up period was divided into three stages: during the hospital stay, at 6 and 12 months after the inclusion in the registry. Demographic and historic data and information about the present case of MI were entered into the patient's individual record card. RESULTS: The median age of all patients was 63 years; 68% of patients were men. The mean age of women was older than that of men. Among all MI cases, 70% were ST-segment elevation myocardial infarction (STEMI). Patients with non-ST-segment elevation myocardial infarction (NSTEMI) were older and had more comorbidities than patients with STEMI. The median time from the first symptoms to ECG recording was two hours, and from the first symptoms to CAG 7 hours. CAG was performed in 91% of patients with STEMI and 84% of patients with NSTEMI. Stenting was performed in 69% of patients. Although many patients had a complicated cardiovascular history, at the time of admission only 31.5% of patients were taking at least one drug from the groups of antiplatelets, oral anticoagulants, statins, and beta-blockers. CONCLUSION: Patients with MI in the Russian Federation are younger than patients with MI in European countries. Among the clinical and historical characteristics, conspicuous is the presence of modifiable risk factors in many patients, as well as the presence of a previous diagnosis of ischemic heart disease. Furthermore, a small proportion of patients took statins, antiplatelet agents or anticoagulants at the outpatient stage, which indicates a great reserve of both primary and secondary prevention of cardiovascular diseases in the Russian Federation. The delayed seeking medical help is also noticeable, which indicates the need for increasing the public awareness of the symptoms of MI and the importance of timely hospitalization.


Myocardial Infarction , Registries , Humans , Russia/epidemiology , Male , Female , Middle Aged , Prospective Studies , Myocardial Infarction/epidemiology , Aged , Electrocardiography , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/therapy , ST Elevation Myocardial Infarction/diagnosis
10.
Kardiologiia ; 64(4): 31-37, 2024 Apr 30.
Article Ru, En | MEDLINE | ID: mdl-38742513

AIM: Identification of clinical and instrumental predictors for non-arrhythmic death in patients with heart failure (HF) and implantable cardioverter-defibrillator (ICD). MATERIAL AND METHODS: Through a telephone survey and examination of medical records from hospital and polyclinic databases, data were obtained on the alive/dead status and causes of death for 260 patients with heart failure (HF) and ICD included in the Kuzbass Registry of Patients with ICD. The follow-up period was 1.5 years. Clinical and instrumental parameters entered into the registry before the ICD implantation were included in a univariate and multivariate step-by-step analysis using the logistic (for qualitative variables) and linear (for quantitative variables) regression with calculation of regression coefficients and construction of a prognostic regression model. The quality of the created model was assessed using a ROC analysis. RESULTS: During the observation period, 54 (20.8%) patients died. In 21 (38.8%) patients, death occurred in the hospital and was caused by acute decompensated heart failure in 15 (71.4%) patients, myocardial infarction in 3 (14.3%) patients, stroke in 1 (4.7%) patient, and pneumonia in 2 (9.5%) patients. 33 (61.2%) patients died outside the hospital; the cause of death was stated as the underlying disease associated with acute decompensated heart failure: in 9 (27.2%) patients, dilated cardiomyopathy; in 1 (3.0%) patient, rheumatic mitral disease; and in 23 (69.7%) patients, ischemic cardiomyopathy. According to the univariate regression model, the risk of death in the long-term period was increased by the QT interval prolongation (U 2.41, p = 0.0161); elevated pulmonary artery systolic pressure (U 4.30, p=0.0000) and increased left atrial size according to echocardiography (U 2.98, p=0.0029); stage IIB HF (OR 2.41; 95% CI: 1.26-4.6), NYHA III-IV (OR 3.03; 95% CI: 1.58-5.81); chronic obstructive pulmonary disease (OR 5.24; 95% CI: 2.04-13.45); and lack of optimal drug therapy (ODT) for HF before ICD implantation (OR 2.41; 95% CI: 1.29-4.49). The multivariate analysis identified the most significant factors included in the prognostic regression model: pulmonary artery systolic pressure above 45 mm Hg, social status, chronic obstructive pulmonary disease, and lack of ODT for HF. CONCLUSION: To ensure a maximum benefit from ICD, the factors that increase the likelihood of non-arrhythmic death should be considered before making a decision on ICD implantation. Particular attention should be paid to mandatory ODT for HF as the main modifiable risk factor for unfavorable prognosis.


Defibrillators, Implantable , Heart Failure , Registries , Humans , Heart Failure/physiopathology , Heart Failure/therapy , Female , Male , Prognosis , Middle Aged , Aged , Prospective Studies , Russia/epidemiology , Cause of Death/trends , Risk Factors
11.
JMIR Res Protoc ; 13: e55297, 2024 May 07.
Article En | MEDLINE | ID: mdl-38713507

BACKGROUND: Injury is a global health concern, and injury-related mortality disproportionately impacts low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries shows that trauma education programs, such as the Rural Trauma Team Development Course (RTTDC), increase clinician knowledge of injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of the RTTDC on process and patient outcomes in LMICs. OBJECTIVE: This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident-related injuries in an African low-resource setting. METHODS: This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident-related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police. RESULTS: The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024. CONCLUSIONS: This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55297.


Accidents, Traffic , Motorcycles , Humans , Accidents, Traffic/mortality , Wounds and Injuries/therapy , Wounds and Injuries/mortality , Patient Care Team/organization & administration , Uganda/epidemiology , Registries , Female , Rural Health Services/organization & administration , Adult , Male , Rural Population
12.
Neurology ; 102(11): e209391, 2024 Jun.
Article En | MEDLINE | ID: mdl-38728654

BACKGROUND AND OBJECTIVES: To investigate the underlying reasons for variability in the incidence rate of amyotrophic lateral sclerosis (ALS) within the Irish population between the years 1996 and 2021. METHODS: The Irish ALS register was used to calculate the incidence and to subsequently extract age at diagnosis (age), year of diagnosis (period), and date of birth (cohort) for all incident patients within the study period (n = 2,771). An age-period-cohort (APC) model using partial least squares regression was constructed to examine each component separately and their respective contribution to the incidence while minimizing the well-known identifiability problem of APC effects. A dummy regression model consisting of 5 periods, 19 cohorts, and 16 age groups was used to examine nonlinear relationships within the data over time. The CIs for each of these were estimated using the jackknife method. RESULTS: The nonlinear model achieved R2 of 99.43% with 2-component extraction. Age variation was evident with those in the ages 65-79 years contributing significantly to the incidence (ßmax = 0.0746, SE = 0.000410, CI 0.00665-0.00826). However, those aged 25-60 years contributed significantly less (ßmin = -0.00393, SE = 0.000291, CI -0.00454 to -0.00340). Each successive period showed an increase in the regression model coefficient suggesting an increasing incidence over time, independent of the other factors examined-an increase of ß from -0.00489 (SE = 0.000264, CI -0.00541 to -0.00437) to 0.00973 (SE = 0.000418, CI 0.0105-0.00891). A cohort effect was demonstrated showing that the contribution of those born between 1927 and 1951 contributed to a significantly greater degree than the other birth cohorts (ßmax = 0.00577, SE = 0.000432, CI 0.00493-0.00662). DISCUSSION: Using the Irish population-based ALS Register, robust age, period, and cohort effects can be identified. The age effect may be accounted for by demographic shifts within the population. Changes in disease categorization, competing risks of death, and improved surveillance may account for period effects. The cohort effect may reflect lifestyle and environmental factors associated with the challenging economic circumstances in Ireland between 1927 and 1951. Age-period-cohort studies can help to account for changes in disease incidence and prevalence, providing additional insights into likely demographic and environmental factors that influence population-based disease risk.


Amyotrophic Lateral Sclerosis , Humans , Amyotrophic Lateral Sclerosis/epidemiology , Ireland/epidemiology , Incidence , Aged , Middle Aged , Male , Female , Adult , Least-Squares Analysis , Aged, 80 and over , Registries , Age Factors , Cohort Effect , Cohort Studies
13.
Lancet Healthy Longev ; 5(5): e326-e335, 2024 May.
Article En | MEDLINE | ID: mdl-38705151

BACKGROUND: Despite advances in heart failure care reducing mortality in clinical trials, it remains unclear whether real-life cohorts have had similar improvements in life expectancy across the age spectrum. We aimed to investigate how mortality trends changed in patients with heart failure over the past 25 years, stratified by age groups. METHODS: Using Danish nationwide registries, we identified patients with new-onset heart failure aged 18-95 years. The 5-year all-cause mortality risk and the absolute risk difference of mortality between patients with heart failure and age-matched and sex-matched heart failure-free controls were assessed using Kaplan-Meier estimates and multivariable Cox regression models. Mortality trends were analysed across five calendar periods (1996-2000, 2001-05, 2006-10, 2011-15, and 2016-20) and three age groups (<65 years, 65-79 years, and ≥80 years). FINDINGS: 194 997 patients with heart failure were included. Mortality significantly decreased from 1996-2000 (66% [95% CI 65·5-66·4]) to 2016-20 (43% [42·1-43·4]), with similar results shown in all age groups (<65 years: 35% [33·9-36·1] to 15% [14·6-16·3]; 65-79 years: 64% [63·1-64·5] to 39% [37·6-39·6]; and ≥80 years: 84% [83·1-84·3] to 73% [71·7-73·9]). Adjusted mortality rates supported these associations. The absolute risk difference declined notably in younger age groups (<65 years: 29·9% [28·8-31·0] to 12·7% [12·0-13·4] and 65-79 years: 41·1% [40·3-41·9] to 25·1% [24·4-25·8]), remaining relatively stable in those aged 80 years or older (30·6% [29·9-31·3] to 28% [27·2-28·8]). INTERPRETATION: Over 25 years, there has been a consistent decrease in mortality among patients with heart failure across age groups, albeit less prominently in patients aged 80 years or older. Further insight is needed to identify effective strategies for improving disease burden in older patients with heart failure. FUNDING: None. TRANSLATION: For the Danish translation of the abstract see Supplementary Materials section.


Heart Failure , Humans , Heart Failure/mortality , Aged , Denmark/epidemiology , Male , Female , Middle Aged , Adult , Aged, 80 and over , Retrospective Studies , Adolescent , Young Adult , Age Factors , Registries
14.
Epidemiol Mikrobiol Imunol ; 73(1): 21-29, 2024.
Article En | MEDLINE | ID: mdl-38697837

OBJECTIVES: Given the lack of data on the seriousness of respiratory syncytial virus (RSV) infections in the Czech Republic, an analysis was made of available data on hospitalizations and the hospitalization risk was estimated by age group. METHODS: Data from the National Registry of Reimbursed Health Services and the National Registry of Hospitalizations were used for the analyses. Hospitalizations and deaths due to RSV infection (diagnoses J12.1, J20.5, J21.0) from 2017-2022 were analyzed by age group. RESULTS: Over the six-year period, there were 6,138 hospitalizations with the above diagnoses, ranging between years from 307 to 2,162. The estimated overall hospitalization risk per 100,000 population and year for diagnoses J12.1, J20.5, and J21.0 was 9.64, varying between 2.87 (2020) and 20.56 (2021). Age-group analysis showed the highest risk for children under 6 months of age (891.6/100,000 population and year) and the lowest for 20-34-year-olds (0.1/100,000 population and year). Children under 1 year of age accounted for 63.1% of hospitalizations with the above diagnoses. For patients 65 years and older, the annual hospitalization rates varied between 3.3-15.3%. The most frequent cause of RSV-associated hospitalizations was bronchitis, diagnosed in 55.4% of patients. Among those hospitalized with diagnoses J12.1, J20.5, and J21.0, 38 deaths were reported, representing a case fatality rate of 0.62%. The highest case fatality rate (6.5%) was observed in the age group 35-49 years. CONCLUSIONS: RSV-associated hospitalizations have been reported in all age groups in the Czech Republic. The highest RSV-associated hospitalization risk in 2017-2022 was estimated among children under 6 months of age. Passive surveillance using the available registries could currently provide the basis for measures specifically tailored to the youngest age categories. Data on the hospitalization of adults, particularly senior citizens, must be improved and complemented with active surveillance.


Hospitalization , Respiratory Syncytial Virus Infections , Humans , Czech Republic/epidemiology , Respiratory Syncytial Virus Infections/epidemiology , Respiratory Syncytial Virus Infections/mortality , Hospitalization/statistics & numerical data , Infant , Child, Preschool , Child , Adult , Middle Aged , Young Adult , Adolescent , Aged , Infant, Newborn , Female , Male , Registries
15.
BMJ Open Respir Res ; 11(1)2024 May 07.
Article En | MEDLINE | ID: mdl-38719500

BACKGROUND: There is a lack of individualised prediction models for patients hospitalised with chronic obstructive pulmonary disease (COPD) for clinical practice. We developed and validated prediction models of severe exacerbations and readmissions in patients hospitalised for COPD exacerbation (SERCO). METHODS: Data were obtained from the Acute Exacerbations of Chronic Obstructive Pulmonary Disease Inpatient Registry study (NCT02657525) in China. Cause-specific hazard models were used to estimate coefficients. C-statistic was used to evaluate the discrimination. Slope and intercept were used to evaluate the calibration and used for model adjustment. Models were validated internally by 10-fold cross-validation and externally using data from different regions. Risk-stratified scoring scales and nomograms were provided. The discrimination ability of the SERCO model was compared with the exacerbation history in the previous year. RESULTS: Two sets with 2196 and 1869 patients from different geographical regions were used for model development and external validation. The 12-month severe exacerbations cumulative incidence rates were 11.55% (95% CI 10.06% to 13.16%) in development cohorts and 12.30% (95% CI 10.67% to 14.05%) in validation cohorts. The COPD-specific readmission incidence rates were 11.31% (95% CI 9.83% to 12.91%) and 12.26% (95% CI 10.63% to 14.02%), respectively. Demographic characteristics, medical history, comorbidities, drug usage, Global Initiative for Chronic Obstructive Lung Disease stage and interactions were included as predictors. C-indexes for severe exacerbations were 77.3 (95% CI 70.7 to 83.9), 76.5 (95% CI 72.6 to 80.4) and 74.7 (95% CI 71.2 to 78.2) at 1, 6 and 12 months. The corresponding values for readmissions were 77.1 (95% CI 70.1 to 84.0), 76.3 (95% CI 72.3 to 80.4) and 74.5 (95% CI 71.0 to 78.0). The SERCO model was consistently discriminative and accurate with C-indexes in the derivation and internal validation groups. In external validation, the C-indexes were relatively lower at 60-70 levels. The SERCO model discriminated outcomes better than prior severe exacerbation history. The slope and intercept after adjustment showed close agreement between predicted and observed risks. However, in external validation, the models may overestimate the risk in higher-risk groups. The model-driven risk groups showed significant disparities in prognosis. CONCLUSION: The SERCO model provides individual predictions for severe exacerbation and COPD-specific readmission risk, which enables identifying high-risk patients and implementing personalised preventive intervention for patients with COPD.


Disease Progression , Patient Readmission , Pulmonary Disease, Chronic Obstructive , Humans , Pulmonary Disease, Chronic Obstructive/therapy , Pulmonary Disease, Chronic Obstructive/epidemiology , Male , Patient Readmission/statistics & numerical data , Female , China/epidemiology , Aged , Prospective Studies , Middle Aged , Risk Assessment , Hospitalization/statistics & numerical data , Registries , Nomograms , Severity of Illness Index
16.
J Glob Health ; 14: 04075, 2024 May 10.
Article En | MEDLINE | ID: mdl-38722093

Background: Digital health records have emerged as vital tools for improving health care delivery and patient data management. Acknowledging the gaps in data recording by a paper-based register, the emergency obstetric and newborn care (EmONC) register used in the labour ward was digitised. In this study, we aimed to assess the implementation outcome of the digital register in selected public health care facilities in Bangladesh. Methods: Extensive collaboration with stakeholders facilitated the development of an android-based electronic register from the paper-based register in the labour rooms of the selected district and sub-district level public health facilities of Bangladesh. We conducted a study to assess the implementation outcome of introducing the digital EmONC register in the labour ward. Results: The digital register demonstrated high usability with a score of 83.7 according to the system usability scale, and health care providers found it highly acceptable, with an average score exceeding 95% using the technology acceptance model. The adoption rate reached an impressive 98% (95% confidence interval (CI) = 98-99), and fidelity stood at 90% (95% CI = 88-91) in the digital register, encompassing more than 80% of data elements. Notably, fidelity increased significantly over the implementation period of six months. The digital system proved a high utility rate of 89% (95% CI = 88-91), and all outcome variables exceeded the predefined benchmark. Conclusions: The implementation outcome assessment underscores the potential of the digital register to enhance maternal and newborn health care in Bangladesh. Its user-friendliness, improved data completeness, and high adoption rates indicate its capacity to streamline health care data management and improve the quality of care.


Registries , Humans , Bangladesh , Pregnancy , Female , Infant, Newborn , Emergency Medical Services/organization & administration , Electronic Health Records , Health Facilities
17.
PLoS One ; 19(5): e0302505, 2024.
Article En | MEDLINE | ID: mdl-38722836

BACKGROUND: Smoking has been associated with a higher risk of contracting pneumonia, but contradictory results have shown that smoking may or may not decrease the risk of dying in pneumonia. The aim of this study is to investigate how smoking is associated with contracting any infection and pneumonia and death. METHOD AND FINDINGS: Participants were drawn from the population-based Cohort of Swedish Men and the Swedish Mammography Cohort, which are representative of the Swedish population. Participants have answered detailed lifestyle questionnaires and have been followed in national registers, such as the Patient Register, Cause of Death register and Swedish Intensive Care Registry. The risks of contracting infection and pneumonia or dying in infection and pneumonia were assessed using Cox regression. Of 62,902 cohort participants, 25,297 contracted an infection of which 4,505 died; and 10,471 contracted pneumonia of which 2,851 died. Compared to never smokers, former smokers at baseline had hazard ratio (HR) 1.08 (95% confidence interval (CI) 1.05-1.12) of contracting and HR 1.19 (95% CI 1.11-1.28) of dying in infection and HR 1.17 (95% CI 1.12-1.23) of contracting and HR 1.16 (95% CI 1.06-1.27) of dying in pneumonia during follow-up. Compared to never smokers, current smokers at baseline had HR 1.17 (95% CI 1.13-1.21) of contracting infection and HR 1.64 (95% CI 1.52-1.77) dying in infection; HR 1.42 (95% CI 1.35-1.49) of contracting pneumonia and HR 1.70 (95% CI 1.55-1.87) of dying in pneumonia during follow-up. The risk of contracting and dying in infection and pneumonia increased in a dose-response manner with number of pack years smoked and decreased with years since smoking cessation. CONCLUSION: Smoking is associated with contracting and dying in any infection and pneumonia and the risk increases with pack years smoked, highlighting the importance of both primary prevention and smoking cessation.


Intensive Care Units , Pneumonia , Smoking , Humans , Male , Pneumonia/mortality , Pneumonia/epidemiology , Middle Aged , Smoking/adverse effects , Sweden/epidemiology , Aged , Female , Risk Factors , Bacterial Infections/mortality , Bacterial Infections/epidemiology , Adult , Cohort Studies , Proportional Hazards Models , Registries
18.
Arch Iran Med ; 27(5): 272-276, 2024 May 01.
Article En | MEDLINE | ID: mdl-38690794

BACKGROUND: Rabies remains a public health problem in middle-income countries like Iran, despite being preventable. This study aimed to evaluate the six-year incidence of animal bites in the southern Caspian Sea region from 2016 to 2022, and focus on estimating the direct costs of animal bite cases using the incidence-based method. METHODS: A multicenter, registry-based study was conducted using surveillance data of animal bites. RESULTS: Of the 40922 cases reported during the study period, 65.9% were male and 34.1% were female. Animal bites were most frequent among individuals over 50 years of age (23.5%), while children under 10 years of age had the lowest frequency of animal bites (2.3%). Animal bites were most common in June. Dogs were responsible for 33277 (81%) cases, cats for 5,624 (13.7%) cases, cows for 1054 (2.5%) cases, and other animals for the remaining cases. During the six-year study period, four deaths due to rabies were reported in the study area. The annual bite incidence rate was 386.3 per 100000 people in northern Iran. The males-to-female ratio was highest in 2019 (M/F ratio=2.4, 95% CI=1.2‒3.4). CONCLUSION: The elderly are at higher risk of animal bites, especially in rural areas. It is important to emphasize the use of protective clothing, washing wounds with soap water and rabies vaccination as initial treatment. Targeted vaccination efforts for eligible animals should be prioritized to minimize unnecessary financial burden. Educating farmers about rabies prevention programs, especially in cases of cow bites, is also important.


Bites and Stings , Rabies , Iran/epidemiology , Humans , Rabies/epidemiology , Rabies/prevention & control , Animals , Bites and Stings/epidemiology , Male , Female , Child , Middle Aged , Adolescent , Child, Preschool , Adult , Incidence , Young Adult , Dogs , Cats , Aged , Infant , Registries , Age Distribution , Sex Distribution , Public Health , Aged, 80 and over , Infant, Newborn
19.
PLoS One ; 19(5): e0302253, 2024.
Article En | MEDLINE | ID: mdl-38696411

BACKGROUND: Over the past decades, the rising incidence rates of endometrial cancer have made it a significant public health concern for women worldwide. Treatment strategies for endometrial cancer vary based on several factors such as stage, histology, the patient's overall health, and preferences. However, limited amount of research on treatment patterns and potential correlations with sociodemographic characteristics among Hispanics is available. This study analyzes the treatment patterns for patients diagnosed with endometrial cancer in Puerto Rico. METHODS: A secondary database analysis was performed on endometrial cancer cases reported to the Puerto Rico Central Cancer Registry-Health Insurance Linkage Database from 2009 to 2015 (n = 2,488). The study population's sociodemographic and clinical characteristics were described, along with an overview of the therapy options provided to patients receiving care on the island. Logistic regression models were used to evaluate the association of sociodemographic/clinical characteristics with treatment patterns stratified by risk of recurrence. RESULTS: In our cohort, most patients were insured through Medicaid and had a median age of 60 years. Almost 90% of patients received surgery as the first course of treatment. Surgery alone was the most common treatment for low-risk patients (80.2%). High-risk patients were more likely to receive surgery with radiotherapy and chemotherapy (24.4%). Patients with Medicare insurance were five times (HR: 4.84; 95% CI: 2.45-9.58; p < 0.001) more likely to receive surgery when compared with patients insured with Medicaid. In contrast, those with private insurance were twice as likely to receive surgery (HR: 2.38; 95% CI: 1.40-4.04; p = 0.001) when compared to those with Medicaid. CONCLUSION: These findings provide insight into the treatment patterns for endometrial cancer in Puerto Rico and highlight the importance of considering factors such as disease risk when making treatment decisions. Addressing these gaps in treatment patterns can contribute to effective management of endometrial cancer.


Endometrial Neoplasms , Humans , Female , Puerto Rico/epidemiology , Endometrial Neoplasms/therapy , Endometrial Neoplasms/epidemiology , Middle Aged , Retrospective Studies , Aged , Adult , Sociodemographic Factors , Registries , Socioeconomic Factors , United States/epidemiology , Medicaid/statistics & numerical data
20.
Orphanet J Rare Dis ; 19(1): 187, 2024 May 06.
Article En | MEDLINE | ID: mdl-38711103

BACKGROUND: Rare disease registries (RDRs) are valuable tools for improving clinical care and advancing research. However, they often vary qualitatively, structurally, and operationally in ways that can determine their potential utility as a source of evidence to support decision-making regarding the approval and funding of new treatments for rare diseases. OBJECTIVES: The goal of this research project was to review the literature on rare disease registries and identify best practices to improve the quality of RDRs. METHODS: In this scoping review, we searched MEDLINE and EMBASE as well as the websites of regulatory bodies and health technology assessment agencies from 2010 to April 2023 for literature offering guidance or recommendations to ensure, improve, or maintain quality RDRs. RESULTS: The search yielded 1,175 unique references, of which 64 met the inclusion criteria. The characteristics of RDRs deemed to be relevant to their quality align with three main domains and several sub-domains considered to be best practices for quality RDRs: (1) governance (registry purpose and description; governance structure; stakeholder engagement; sustainability; ethics/legal/privacy; data governance; documentation; and training and support); (2) data (standardized disease classification; common data elements; data dictionary; data collection; data quality and assurance; and data analysis and reporting); and (3) information technology (IT) infrastructure (physical and virtual infrastructure; and software infrastructure guided by FAIR principles (Findability; Accessibility; Interoperability; and Reusability). CONCLUSIONS: Although RDRs face numerous challenges due to their small and dispersed populations, RDRs can generate quality data to support healthcare decision-making through the use of standards and principles on strong governance, quality data practices, and IT infrastructure.


Rare Diseases , Registries , Humans
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