Clinical Epidemiology最新文献

Purpose: To examine the accuracy of the diagnoses of early-onset neonatal infection in the Danish National Patient Register.

Patients and methods: All Danish neonates born after 35 weeks of gestation with an ICD10 diagnosis of sepsis or meningitis within the first week of life between 2010 and 2018 were identified. To examine the validity of the diagnoses, medical records were reviewed for 500 neonates diagnosed with sepsis and all 63 neonates diagnosed with meningitis. Proven infection was defined by bacterial pathogens identified from blood or cerebrospinal fluid. Probable sepsis was defined as at least 5 days of antibiotic treatment, two clinical signs of infection, and one abnormal blood biomarker. Probable meningitis was defined as at least 14 days of antibiotics, neurological affection, and cerebrospinal fluid analysis consistent with meningitis. Positive predictive values (PPVs) with 95% CI were estimated using the proven definition of infection as well as the criteria for either proven or probable infection.

Results: The PPV for sepsis diagnoses using the proven definition was 0.04 (0.02, 0.06), while the PPV using both the proven and probable definition was 0.52 (0.45, 0.58). Sepsis diagnoses with a specified pathogen showed the highest PPV for proven sepsis at 0.36 (0.29, 0.43) and for proven or probable sepsis at 0.65 (0.58, 0.72). The PPV for meningitis diagnoses using the proven definition was 0.24 (0.13, 0.37), while the PPV using both the proven and probable definition was 0.38 (0.25, 0.52).

Conclusion: We found a poor validity for the ICD10 diagnoses of early-onset neonatal infection in the Danish National Patient Register. This highlights that the diagnoses should be used cautiously in future research and surveillance and emphasises the need for supporting information on microbiological samples. Additionally, this highlights the importance of establishing a consensus definition of neonatal sepsis to improve diagnostic accuracy.

Introduction: Studying patterns of death, particularly premature deaths (<75 years), provides insights to address health inequities among those living. Multiple coding systems for cause of death (COD) exist. The Leading Causes of Death (LCD) scheme is designed for identifying priority COD for interventions in global populations. The extent to which such classification is effective for identifying priority causes of premature mortality among subpopulations with chronic health conditions, such as inflammatory bowel disease (IBD), is unknown.

Objective: To evaluate the usability of the LCD for characterizing premature mortality among those with IBD.

Methods: We conducted a population-based matched case control study of persons with IBD who died between 2010 and 2018 using linked health administrative data from Ontario, Canada. Individuals with IBD were matched with five decedents without IBD based on sex and years of birth and death. We compared COD for premature and overall mortality using two classification structures: the LCD scheme and the International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10) chapters.

Results: Among 7,919 decedents with IBD (39,414 matched controls), 47% died prematurely. With the LCD framework, COD differences for premature mortality were not detectable as 29% were allocated to the residual category (Standardized differences [SD]: 18%). Most residual deaths were due to neoplasms (34%) or diseases of the gastrointestinal system (32%). Using ICD-10 chapters, premature deaths were more commonly due to diseases of the digestive system than for matched controls (13% vs 5%, SD: 31%).

Discussion: The LCD coding scheme provides more granular COD details compared to the ICD-10 chapters. However, a larger proportion of deaths among people with IBD were allocated to the residual category, limiting its utility for enabling healthcare systems to identify priority targets to reduce premature mortality. Further work to develop and validate a framework for premature COD classification in populations with IBD is needed.

Purpose: To compare the effect estimates obtained from patients with different levels of electronic health record (EHR)-continuity in four empirical studies: risk of pneumonia among 1) new users of proton pump inhibitors (PPI) vs H2 receptor antagonists, or 2) new users of PPI vs non-PPI users; risk of major bleeding among 3) new users of warfarin vs direct-acting oral anticoagulants, or 4) new users of oral anti-coagulants (OAC) vs non-OAC users.

Patients and methods: Patients were identified in 2 US EHR systems (MA system, NC system) linked with Medicare claims data (2007/1/1 - 2014/12/31) separately. We calculated incidence rates (IR), incidence rate differences (IRD), and hazard ratios (HR) in the total linked study population and after excluding patients with the lowest 25%, 50%, or 75% of EHR-continuity scores. We quantified bias in IRD and propensity score (PS) decile-adjusted HR.

Results: In the MA system, IRs based on EHR-only data underestimated true rates by 44.1% to 76.2%, reduced to 12.9% to 46.5%. After excluding the lowest 75% of EHR-continuity patients, underestimation was more pronounced in non-user comparator designs. Absolute IRD bias was small for PPI vs H2RA (0.4%) and warfarin vs DOAC (0.7%), but larger for PPI vs non-PPI (19.1%) and OAC vs non-OAC (7.8%). Relative HR bias was 13.3% (PPI vs H2RA), 18.9% (PPI vs non-PPI), 3.0% (warfarin vs DOAC), and 31.5% (OAC vs non-OAC). Excluding lower-continuity patients and PS adjustment reduced IRD bias, while restricting to higher-continuity patients modestly improved HR bias.

Conclusion: Limiting analyses to patients with higher EHR-continuity can reduce IR underestimation and bias in effect estimates, particularly on the IRD scale. While PS adjustment mitigates some bias, EHR-discontinuity remains a source of bias, especially in studies using non-user comparators. These findings underscore the importance of balancing EHR-continuity with sample size considerations in pharmacoepidemiologic research.

Purpose: Thyroid cancer (TC) survivors face an increased risk of second primary cancers (SPCs). While previous research on the risk of SPCs among TC patients has been conducted in other regions, comprehensive data from Northern Europe remain limited. Our register-based cohort study aimed to evaluate the risk of SPCs among Finnish TC survivors.

Patients and methods: We obtained data on all patients diagnosed with TC in Finland in 1953-2022 from the Finnish Cancer Registry (FCR). Standardized incidence ratios (SIRs) of SPCs were calculated relative to the risk of cancer in the general population.

Results: We identified 14,520 patients with TC (3,212 males, 22%; 11,308 females, 78%), with a median follow-up of 12.1 years. A metachronous SPC was diagnosed in 16.4% (n=527) of males and 15.5% (n=1,744) of females. The overall SPC risk was elevated for both males (SIR 1.23, 95% CI 1.12-1.34; EAR 2.39/1,000 PYs) and females (1.24, 1.19-1.30; EAR 1.92/1,000 PYs). Female patients with papillary TC (PTC) displayed increased SIRs for breast (SIR 1.26, 95% CI:1.15-1.37), urinary organ (1.50, 1.19-1.86), brain (1.85, 1.48-2.29), and hematolymphoid cancers (1.31, 1.10-1.54). Males with PTC showed an increased risk of urinary organ (SIR 1.39, 1.01-1.85), brain (2.73, 1.69-4.17), and hematolymphoid cancers (1.52, 1.12-2.01). The elevated SPC risk of the breast and brain persisted even after 20 years of follow-up. An increased incidence of SPCs of the urinary organs, brain, and hematolymphoid tissues was observed in females diagnosed with follicular TC (FTC) or medullary TC (MTC) in 1953-1985.

Conclusion: Our results indicate an excess risk of cancers of the breast, urinary organs, brain and hematolymphoid tissues for Finnish patients with a history of PTC. For FTC and MTC risk of cancers of the urinary organs, brain, and hematolymphoid tissues is specific for female patients diagnosed in 1953-1985.

Introduction: Mild traumatic brain injury (mTBI) is an important public health issue, but France does not have a dedicated epidemiological surveillance system for mTBI. Data on Emergency departments (ED) of the OSCOUR network could be useful for setting up a dedicated mTBI surveillance system. However, the performance of potential algorithms based on ICD-10 codes for identifying cases of mTBI in OSCOUR has not been assessed. The objective of this study is to measure the performance of various potential algorithms, based on ICD-10 codes, for identifying mTBI ED visits in the OSCOUR database.

Material and methods: We performed a retrospective multicenter validation study of algorithms for identifying mTBI based on ICD-10 codes using the OSCOUR database. We calculated sensitivity, specificity, positive and negative predictive values of the various algorithms by using medical charts from ED visits as a reference source. Our study population consisted of a random sample of patients of all ages in France who visited one of the four ED from the OSCOUR network, which participated in our study in 2019.

Results: 5,185 medical charts were reviewed. Algorithms performance varied according to population characteristics, and none of the algorithms tested for the identification of mTBI cases achieved the minimum performance requirements (sensitivity and PPV ≥ 80%) over all age or sex groups. However, sub-group analyses highlighted that one algorithm (BA31_OPT1) had acceptable performance for identifying mTBI according to our "broad" definition for people under 18 years old. Sensitivity, specificity, PPV and NPV for this algorithm were 85.2%, 99.4%, 95.2% and 98%, respectively.

Conclusion: Most mTBI case identification algorithms performed poorly in identifying mTBI cases of all ages in the OSCOUR database. Nevertheless, it was possible to identify cases defined according to a "broad" mTBI definition in the paediatric population (0-17 years).

Purpose: Small cell lung cancer (SCLC) is a highly aggressive malignancy with poor prognosis. Studies capturing the impact of recently approved immunotherapies are limited, highlighting a knowledge gap regarding their real-world use and effectiveness.  .

Patients and methods: We examined data from 29949 patients with extensive-stage (ES)-SCLC across observational studies from the United States, United Kingdom, Spain, Taiwan, South Korea, and Japan to describe the clinical course of ES-SCLC. Data sources included electronic health record databases, registries, and claims data over time periods ranging between 2013 and 2023. Patient characteristics, recent treatment patterns, and real-world overall survival (rwOS) were assessed in each country.

Results: The most common first-line (1L) treatment was platinum plus etoposide without anti-PD-L1 agents (59-89%), followed by platinum plus etoposide with anti-PD-L1 agents (9-38%). Second-line (2L) and third-line (3L) treatments varied widely across countries. Median rwOS ranged from 8.1-11.3 months following 1L initiation, 4.8-6.9 months following 2L, and 4.1-5.5 months following 3L. Patients receiving compared to those not receiving 1L anti-PD-L1 therapy showed numerically higher median rwOS following 1L initiation, with no meaningful difference in rwOS following 2L or 3L therapy.

Conclusion: In our evaluation of real-world treatment patterns and outcomes among patients with ES-SCLC from six countries, we found that rwOS in 1L, 2L and 3L was consistently poor across countries, despite differences in patient characteristics and treatment patterns. These findings may support the generalizability of clinical evidence across geographies and highlight the need for further research to optimize treatment strategies to improve patient outcomes globally.

Background: Several prognostic models have been developed to estimate operative mortality in patients undergoing surgery for infective endocarditis (IE). However, their external validity and performance remain uncertain, limiting clinical applicability. This study aimed to externally validate and compare the performance of contemporary IE-specific and generic cardiac surgery (EuroSCORE II) risk scores in a large single-center cohort.

Methods: Eighteen operative IE-specific risk scores, along with EuroSCORE II, were retrospectively applied to a database of 689 patients undergoing cardiac surgery for IE. Discrimination was evaluated using the area under the receiver operating characteristic curve (AUC), while calibration was assessed using the Hosmer-Lemeshow test, Brier score, and calibration slopes/intercepts. For each score, the type of validation reported in the original study was critically examined, noting that validation was not always performed. Additionally, the inclusion of IE-specific variables, such as pathogen type and valvular complications, was assessed to evaluate the reliability and clinical applicability of each score.

Results: Among the 689 patients, 30% were female, with a median age of 69 years. The most frequent pathogens were Streptococcus (26%), Staphylococcus aureus (18%), coagulase-negative staphylococci (18%), and Enterococcus faecalis (16%). Operative mortality was 10.6% (n = 73). The RISK-E score showed the highest discrimination (AUC: 0.742), followed by APORTEI (0.734) and modified MELD-XI (0.730). All scores demonstrated good calibration, with scaled Brier scores above 0.8. Scores incorporating IE-specific variables generally performed better, while several widely used generic scores, including EuroSCORE II, overestimated operative risk. External validation revealed lower AUCs for many scores compared to original reports, highlighting the importance of rigorous evaluation.

Conclusion: The RISK-E score demonstrated the highest discriminative ability and satisfactory calibration for predicting operative mortality in patients undergoing surgery for infective endocarditis. These results support the role of externally validated, IE-specific prognostic tools in guiding clinical assessment and selecting appropriate perioperative strategies.

Purpose: In the Danish and other national health registries, colorectal cancer (CRC) recurrence is not routinely registered. Algorithms to label patients with recurrence in Denmark exist but produce cohorts with a risk of selection bias due to either pre- or postoperative exclusion criteria. In this study, we aimed to refine and increase the generalizability of an existing registry-based algorithm.

Patients and methods: Data from 5077 patients from an institution and a regional database, encompassing several departments of surgery in Denmark, were retrieved. Patients with non-metastatic CRC were included from 2008 to 2019. Electronic health journal-based recurrence registration was used as reference for the algorithm. Patients were linked with data from the Danish Colorectal Cancer Group database, the Danish National Health Registry, the Danish Cancer Registry, and the Danish Pathology Registry. The algorithm utilized metastasis, chemotherapy, pathology, and local recurrence codes. Refinement of the algorithm included the addition of targeted and radiation therapy codes and including patients who died within 180 days after surgery, along with revising the pathology codes and removing any preoperative exclusion criteria. Performance metrics were evaluated in 10,000 bootstrapped runs, while all-stage and stage-specific cumulative incidence of recurrence and overall survival were estimated.

Results: The refined algorithm included more patients than the conventional algorithm (4388 vs 3684) and performed marginally better in terms of sensitivity (0.92 (95% CI 0.89-0.94) vs 0.90 (95% CI 0.87-0.92)) and specificity (0.97 (95% CI 0.97-0.98) vs 0.96 (95% CI 0.95-0.96). A significant difference in cumulative incidence of recurrence for UICC stage I was detected between the conventional algorithm and reference, which was not significant when using the refined algorithm.

Conclusion: The refined algorithm improves identification of CRC recurrence in national data, enabling broader inclusion and better representation of population subgroups.

Purpose: This study aimed to compare the burden of malignant neoplasm of bone and articular cartilage (MNBAC) between China and the Group of Twenty (G20) countries from 1990 to 2021 and to project trends in China to 2030, thereby informing the development of targeted interventions.

Methods: We extracted data on the incidence, prevalence, mortality, disability-adjusted life years (DALYs), and their corresponding age-standardized rates (ASRs) for MNBAC from the Global Burden of Disease (GBD) 2021 study. Trends were assessed based on the magnitude and precision of the estimates, without relying on statistical significance testing. Joinpoint regression identified periods with meaningful trend changes, expressed as the average annual percent change (AAPC). Decomposition analysis was employed to quantify the drivers of changes in incidence, prevalence, mortality, and DALYs. The Bayesian age-period-cohort (BAPC) model was used to project the ASR burden of MNBAC in China up to 2030.

Results: From 1990 to 2021, the absolute number of MNBAC cases in China increased substantially. China's relative ranking among G20 countries rose dramatically: its age-standardized incidence rate (ASIR) climbed from 19th to 1st, age-standardized prevalence rate (ASPR) from 20th to 1st, age-standardized mortality rate (ASMR) from 13th to 4th, and age-standardized DALY rate (ASDR) from 16th to 6th. The MNBAC burden was consistently higher in males than females across all G20 countries. Decomposition analysis indicated that population aging and epidemiological changes were the primary drivers of the increasing burden in China, whereas population growth was the dominant factor in the G20 nations overall. Projections from the BAPC model suggest a decline in MNBAC-related ASIR, ASMR, and ASDR in China from 2022 to 2030.

Conclusion: Despite a substantial increase in the MNBAC burden in China over the past three decades, our projections indicate a forthcoming decline in the ASIR, ASMR, and ASDR, which is likely attributable to sustained public health efforts. These findings underscore the necessity for continued, targeted interventions, particularly for males and high-risk age groups.

Background: Shoulder injuries are a prevalent form of musculoskeletal disorders and common reason to seek healthcare. Health system level care utilization patterns for shoulder disorders are unknown. Accordingly, we described the frequency and timing of diagnostic imaging and treatment for a new episode of shoulder pain and determine usage variations across common diagnostic subgroups, military, and private sector care clinics.

Methods: A retrospective cohort of US Military Health System beneficiaries (n = 456,241) classified into 1) non-specific shoulder diagnosis only, 2) rotator cuff/sub-acromial pain, 3) acromioclavicular (AC joint) dysfunction, 4) shoulder instability/dislocation, 5) hypomobility/adhesive capsulitis, 6) osteoarthrosis, and 7) multiple diagnoses. Outcomes were healthcare use encounters within the first three months of the index visit classified into diagnostic imaging, pharmacological, and non-pharmacological treatments.

Results: The mean age of the cohort was 41 years old (SD 13). A majority of the cohort never received diagnostic imaging (76.7%). Advanced imaging was common for the multiple diagnoses group (53.6% of all advanced imaging). NSAIDS was the most common pharmacological treatment with 10.4% receiving at least one prescription, and physical therapy was the most common nonpharmacologic treatment received by 31% of the cohort. There was lower physical therapy and active treatment use and higher MRI or X-ray use for the same diagnostic group when care was initiated in a civilian clinic. Patients with rotator cuff disorders, multiple shoulder diagnoses, and hypomobility disorders were likely to have received at least one steroid joint injection if care was initiated in civilian compared to military clinics (28.1% vs 16%; 41.2% vs 32%; and 18.6% vs 13.3%, respectively).

Conclusion: Care patterns for high volume shoulder injuries were largely congruent across military and civilian clinics. However, for specific diagnostic groups, use of imaging, steroid injections and physical therapy varied notably between military and civilian clinics.