Categories
Nevin Manimala Statistics

Target trial emulation with multi-state model analysis to assess treatment effectiveness using clinical COVID-19 data

BMC Med Res Methodol. 2023 Sep 2;23(1):197. doi: 10.1186/s12874-023-02001-8.

ABSTRACT

BACKGROUND: Real-world observational data are an important source of evidence on the treatment effectiveness for patients hospitalized with coronavirus disease 2019 (COVID-19). However, observational studies evaluating treatment effectiveness based on longitudinal data are often prone to methodological biases such as immortal time bias, confounding bias, and competing risks.

METHODS: For exemplary target trial emulation, we used a cohort of patients hospitalized with COVID-19 (n = 501) in a single centre. We described the methodology for evaluating the effectiveness of a single-dose treatment, emulated a trial using real-world data, and drafted a hypothetical study protocol describing the main components. To avoid immortal time and time-fixed confounding biases, we applied the clone-censor-weight technique. We set a 5-day grace period as a period of time when treatment could be initiated. We used the inverse probability of censoring weights to account for the selection bias introduced by artificial censoring. To estimate the treatment effects, we took the multi-state model approach. We considered a multi-state model with five states. The primary endpoint was defined as clinical severity status, assessed by a 5-point ordinal scale on day 30. Differences between the treatment group and standard of care treatment group were calculated using a proportional odds model and shown as odds ratios. Additionally, the weighted cause-specific hazards and transition probabilities for each treatment arm were presented.

RESULTS: Our study demonstrates that trial emulation with a multi-state model analysis is a suitable approach to address observational data limitations, evaluate treatment effects on clinically heterogeneous in-hospital death and discharge alive endpoints, and consider the intermediate state of admission to ICU. The multi-state model analysis allows us to summarize results using stacked probability plots that make it easier to interpret results.

CONCLUSIONS: Extending the emulated target trial approach to multi-state model analysis complements treatment effectiveness analysis by gaining information on competing events. Combining two methodologies offers an option to address immortal time bias, confounding bias, and competing risk events. This methodological approach can provide additional insight for decision-making, particularly when data from randomized controlled trials (RCTs) are unavailable.

PMID:37660025 | DOI:10.1186/s12874-023-02001-8

Categories
Nevin Manimala Statistics

Psychometric and structural properties of the Karolinska Exhaustion Disorder Scale: a 1,072-patient study

BMC Psychiatry. 2023 Sep 2;23(1):642. doi: 10.1186/s12888-023-05138-4.

ABSTRACT

OBJECTIVE: Exhaustion disorder is a stress-related diagnosis that was introduced in 2005 to the Swedish version of the International Statistical Classification of Diseases and Related Health Problems, 10th edition (ICD-10). The Karolinska Exhaustion Disorder Scale (KEDS) was developed to assess exhaustion disorder symptomatology. While the KEDS is intended to reflect a single construct and be used based on its total score, the instrument’s characteristics have received limited attention. This study investigated the KEDS’s psychometric and structural properties in a large clinical sample.

METHODS: The study relied on data from 1,072 patients diagnosed with exhaustion disorder that were included in two clinical trials in Sweden. We investigated the dimensionality, homogeneity, and reliability of the KEDS using advanced statistical techniques, including exploratory structural equation modeling (ESEM) bifactor analysis.

RESULTS: A one-factor confirmatory analytic model exhibited a poor fit, suggesting at least a degree of multidimensionality. The ESEM bifactor analysis found the general factor to explain about 72% of the common variance extracted, with an omega hierarchical coefficient of 0.680. Thus, the ESEM bifactor analysis did not clearly support the scale’s essential unidimensionality. A homogeneity analysis revealed a scale-level H of only 0.296, suggesting that KEDS’s total scores do not accurately rank individuals on the latent continuum assumed to underlie the measure. The KEDS’s reliability was modest, signaling considerable measurement error.

CONCLUSION: Findings reveal important limitations to the KEDS with possible implications for the status of exhaustion disorder as a nosological category.

TRIAL REGISTRATION: This study was pre-registered on Open Science Framework (osf.io) on April 24, 2022 ( https://osf.io/p34sq/ ).

PMID:37660017 | DOI:10.1186/s12888-023-05138-4

Categories
Nevin Manimala Statistics

Pre-pregnancy obesity is not associated with poor outcomes in fresh transfer in vitro fertilization cycles: a retrospective study

BMC Pregnancy Childbirth. 2023 Sep 2;23(1):633. doi: 10.1186/s12884-023-05917-7.

ABSTRACT

PURPOSE: The impact of body mass index (BMI) on in vitro fertilization (IVF) has been well acknowledged; however, the reported conclusions are still incongruent. This study aimed to investigate the effect of BMI on IVF embryos and fresh transfer clinical outcomes.

METHODS: This retrospective cohort analysis included patients who underwent IVF/ICSI treatment and fresh embryo transfer from 2014 to March 2022. Patients were divided into the underweight group: BMI < 18.5 kg/m2; normal group: 18.5 ≤ BMI < 24 kg/m2; overweight group: 24 ≤ BMI < 28 kg/m2; and obesity group: BMI ≥ 28 kg/m2. A generalized linear model was used to analyze the impact of BMI on each IVF outcome used as a continuous variable.

RESULTS: A total of 3465 IVF/ICSI cycles in the embryo part; and 1698 fresh embryo transplanted cycles from the clinical part were included. Available embryos rate (61.59% vs. 57.32%, p = 0.007) and blastocyst development rates (77.98% vs. 66.27%, p < 0.001) were higher in the obesity group compared to the normal BMI group. Also, the fertilization rate of IVF cycles in the obesity group was significantly decreased vs. normal BMI group (normal: 62.95% vs. 66.63% p = 0.006; abnormal: 5.43% vs. 7.04%, p = 0.037), while there was no difference in ICSI cycles. The clinical outcomes of overweight and obesity groups were comparable to the normal group. The gestational age of the obesity group was lower compared to the normal group (38.08 ± 1.95 vs. 38.95 ± 1.55, p = 0.011). The adjusted OR (AOR) of BMI for the preterm birth rate of singletons was 1.134 [(95% CI 1.037-1.240), p = 0.006]. BMI was significantly associated with live birth rate after excluded the PCOS patients [AOR: 1.042 (95% CI 1.007-1.078), p = 0.018]. In young age (≤ 35 years), clinical pregnancy rate and live birth rate were positively correlated with BMI, AOR was 1.038 [95% CI (1.001-1.076), p = 0.045] and 1.037 [95% CI (1.002-1.074) p = 0.038] respectively.

CONCLUSION: Being overweight and obese was not associated with poor IVF outcomes but could affect blastocyst formation. ICSI could help to avoid low fertilization in obese patients. Also, obesity was associated with increased rates of premature singleton births.

PMID:37660016 | DOI:10.1186/s12884-023-05917-7

Categories
Nevin Manimala Statistics

Professional calling among nursing students: a latent profile analysis

BMC Nurs. 2023 Sep 2;22(1):299. doi: 10.1186/s12912-023-01470-y.

ABSTRACT

BACKGROUND: One factor that influences nursing students’ decision to pursue a nursing career is professional calling. It is important to comprehend nursing students’ professional calling, which may have an impact on their career choice and career development.

OBJECTIVES: To investigate possible calling types and contributing variables among nursing students.

DESIGN: Cross-sectional descriptive study.

PARTICIPANTS: A total of 10,583 nursing students were enrolled in this survey.

METHODS: From November 16th, 2022, to January 17th, 2023, a cross-sectional study was carried out among nursing students using a convenient sampling. The subjects were given the Chinese Calling Scale and the General Demographic Information Questionnaire. Latent profile analysis (LPA) was used to separate nursing students’ professional calling into a variety of subgroups. To find the variables connected to the prospective calling categories, we used ordinal and multinomial Logistic regression analysis.

RESULTS: Respondents were divided into three calling groups, low (N = 3204), moderate (N = 4492), and high calling group (N = 2887), which accounted for 30.3%, 42.4%, and 27.3% of the total respondents, respectively, in accordance with the findings of the latent profile analysis. Across scale scores and dimensions for the three separate categories, three groups demonstrated statistically significant differences (both p < 0.001). Profile membership was predicted by 8 factors such as age, gender, location of origin, first volunteer experience, highest degree earned, marital status, student leadership experience, and political appearance.

CONCLUSION: Three latent calling patterns were found, and there was calling variability across nursing students. Special care should be given to students with low calling. Nursing students must use professional education tools to help them develop their career calling and stabilize the nursing team.

PMID:37660012 | DOI:10.1186/s12912-023-01470-y

Categories
Nevin Manimala Statistics

Excess mortality during the Coronavirus disease pandemic in Korea

BMC Public Health. 2023 Sep 2;23(1):1698. doi: 10.1186/s12889-023-16546-2.

ABSTRACT

BACKGROUND: Although the ongoing epidemics of Coronavirus disease 2019 (COVID-19) may have affected the mortality trend of the nation, the national level assessment of excess mortality (changes in overall mortality in the entire population) is still scarce in Korea. Therefore, this study evaluated the excess mortality during the COVID-19 pandemic in Korea using the certified mortality data.

METHODS: Monthly mortality and population data from January 2013 to June 2022 was obtained from the National Health Insurance Service database and Statistics Korea. A quasi-Poisson interrupted time-series model adjusted for age structure, population, seasonality, and long-term trends was used to estimate the counterfactual projections (expected) of mortality during the COVID-19 pandemic (March 2020 to June 2022). The absolute difference (observed-expected) and ratio (observed / expected) of mortality were calculated. Stratified analysis based on pandemic years (years 2020, 2021, and 2022), sex, and age groups (aged 0-4, 5-19, 20-64, and ≥ 65 years) were conducted.

RESULTS: An 8.7% increase in mortality was observed during the COVID-19 pandemic [absolute difference: 61,277 persons; ratio (95% confidence interval (CI)): 1.087 (1.066, 1.107)]. The gap between observed and estimated mortality became wider with continuation of the pandemic [ratio (95% CI), year 2020: 1.021 (1.003, 1.040); year 2021: 1.060 (1.039, 1.080), year 2022: 1.244 (1.219, 1.270)]. Although excess mortality across sex was similar, the adult [aged 20-64, ratio (95% CI): 1.059 (1.043, 1.076)] and elderly [aged 65-, ratio (95% CI): 1.098 (1.062, 1.135)] population showed increased excess mortality during the pandemic.

CONCLUSIONS: Despite Korea’s successful quarantine policy response, the continued epidemic has led to an excess mortality. The estimated mortality exceeded the number of deaths from COVID-19 infection. Excess mortality should be monitored to estimate the overall impact of the pandemic on a nation.

PMID:37660007 | DOI:10.1186/s12889-023-16546-2

Categories
Nevin Manimala Statistics

Progranulin promoted the proliferation, metastasis, and suppressed apoptosis via JAK2-STAT3/4 signaling pathway in papillary thyroid carcinoma

Cancer Cell Int. 2023 Sep 2;23(1):191. doi: 10.1186/s12935-023-03033-2.

ABSTRACT

BACKGROUND: Progranulin (PGRN), a glycoprotein secreted by a wide range of epithelial cells and plays an important role in inflammatory mechanisms and tumor progression. In this study, the expression, and functions of PGRN in papillary thyroid carcinoma (PTC) was examined to explore the potential pathogenesis of PTC.

METHODS: Western blotting and qRT-PCR were used to detect the relationship between PGRN expression and clinicopathological characteristics of patients with PTC. PTC cell lines with PGRN overexpression and with PGRN knockdown were established to explore their effects on the biological behavior. Western blotting was used to detect the changes of relevant molecules and JAK2-STAT3/4 signaling pathway. Moreover, rescue experiments validated the involvement of the JAK2-STAT3/4 signaling pathway. And statistical analyses were analyzed using SPASS 21.0 and graph generation were performed using GraphPad Prism 8.0.

RESULTS: PGRN was overexpressed in PTC tissue and increased by 75% at mRNA level and 161% at relative protein level in the patients with lymph node metastasis compared to without lymph node metastasis. Besides, PGRN regulated and promoted PTC cell proliferation, migration, invasion, and inhibited cell apoptosis. With PGRN overexpressed, relevant molecules including the expression of BCL2/BAX, BCL2/BAD, CyclinD1, MMP2, vimentin and N-cadherin were increased, the expression level of E-cadherin was decreased, and the phosphorylation of JAK2 and STAT3/4 were increased. JAK inhibitor (JSI-124) rescued these changes of PTC cells induced by overexpressed PGRN.

CONCLUSIONS: These findings revealed that PGRN promote the progression of PTC through the JAK2-STAT3/4 pathway, and PGRN could be served as a potential therapeutic target for PTC.

PMID:37660003 | DOI:10.1186/s12935-023-03033-2

Categories
Nevin Manimala Statistics

Prediction models using artificial intelligence and longitudinal data from electronic health records: a systematic methodological review

J Am Med Inform Assoc. 2023 Sep 2:ocad168. doi: 10.1093/jamia/ocad168. Online ahead of print.

ABSTRACT

OBJECTIVE: To describe and appraise the use of artificial intelligence (AI) techniques that can cope with longitudinal data from electronic health records (EHRs) to predict health-related outcomes.

METHODS: This review included studies in any language that: EHR was at least one of the data sources, collected longitudinal data, used an AI technique capable of handling longitudinal data, and predicted any health-related outcomes. We searched MEDLINE, Scopus, Web of Science, and IEEE Xplorer from inception to January 3, 2022. Information on the dataset, prediction task, data preprocessing, feature selection, method, validation, performance, and implementation was extracted and summarized using descriptive statistics. Risk of bias and completeness of reporting were assessed using a short form of PROBAST and TRIPOD, respectively.

RESULTS: Eighty-one studies were included. Follow-up time and number of registers per patient varied greatly, and most predicted disease development or next event based on diagnoses and drug treatments. Architectures generally were based on Recurrent Neural Networks-like layers, though in recent years combining different layers or transformers has become more popular. About half of the included studies performed hyperparameter tuning and used attention mechanisms. Most performed a single train-test partition and could not correctly assess the variability of the model’s performance. Reporting quality was poor, and a third of the studies were at high risk of bias.

CONCLUSIONS: AI models are increasingly using longitudinal data. However, the heterogeneity in reporting methodology and results, and the lack of public EHR datasets and code sharing, complicate the possibility of replication.

REGISTRATION: PROSPERO database (CRD42022331388).

PMID:37659105 | DOI:10.1093/jamia/ocad168

Categories
Nevin Manimala Statistics

Prevalence and Predictors of Peroneal Tendon Instability Accompanying Calcaneal Fractures

Foot Ankle Int. 2023 Sep 2:10711007231175666. doi: 10.1177/10711007231175666. Online ahead of print.

ABSTRACT

BACKGROUND: We aimed to find the prevalence of peroneal tendon instability (PTI) accompanying different types of calcaneal fractures and to determine predictors of PTI based on preoperative CT scanning.

METHODS: In a retrospective cross-sectional study, preoperative CT scans of 400 consecutive calcaneal fractures undergoing surgery were reviewed for comminuted fragments in the lateral gutter of the ankle, fractures at the tip of the lateral malleolus, dislocated peroneal tendons, excessive displacement of the lateral calcaneal wall, calcaneal fracture-dislocation, superior peroneal retinaculum (SPR) avulsion fracture (fleck sign), and shape of the retromalleolar groove. The correlation of these variables with intraoperative SPR stress test, defined as the diagnostic criteria for PTI in calcaneal fractures, was evaluated.

RESULTS: In total, 369 patients (mean age, 39 ± 13; range, 11-72 years), with 321 (87.0%) of them male, were included. Among all calcaneal fractures, 67 cases (16.7%) had associated PTI as confirmed intraoperatively by an SPR stress test. A statistically significant association was found between PTI in calcaneal fractures and comminuted fragments in the lateral gutter of the ankle (P = .03), dislocated peroneal tendons (P < .001), calcaneal fracture-dislocation (P < .001), SPR avulsion fracture (P < .001), and Sanders type IV of calcaneal fracture (P = .02). There was no statistically significant relationship between PTI and the mechanism of injury (P = .98), side of fracture (P = .30), uni- or bilateral calcaneal fractures (P = .27), a fracture at the tip of lateral malleolus (P = .69), shape of the retromalleolar groove (P = .78), or excessive displacement of the lateral calcaneal wall (P = .06). The most specific CT finding to predict PTI accompanying calcaneal fractures was calcaneal fracture-dislocation (99.1%).

CONCLUSION: Following calcaneal fracture fixation, PTI was confirmed with intraoperative SPR stress test in one-sixth of cases. With the exception of calcaneal fracture-dislocation, preoperative findings on CT scanning and calcaneal fracture pathoanatomy are insufficient to diagnose PTI accompanying calcaneal fractures.

LEVEL OF EVIDENCE: Level III, retrospective case control study.

PMID:37658714 | DOI:10.1177/10711007231175666

Categories
Nevin Manimala Statistics

Compare the effectiveness of extracorporeal shockwave and hyperbaric oxygen therapy on enhancing wound healing in a streptozotocin-induced diabetic rodent model

Kaohsiung J Med Sci. 2023 Sep 2. doi: 10.1002/kjm2.12746. Online ahead of print.

ABSTRACT

Studies have revealed that both extracorporeal shock-wave therapy (ESWT) and hyperbaric oxygen therapy (HBOT) can accelerate wound healing. This study aimed to compare the effectiveness of ESWT and HBOT in enhancing diabetic wound healing. A dorsal skin defect in a streptozotocin-induced diabetes rodent model was used. Postoperative wound healing was assessed once every 3 days. Histologic examination was performed with hematoxylin and eosin staining. Proliferation marker protein Ki-67 (Ki-67), endothelial nitric oxide synthase (eNOS), vascular endothelial growth factor (VEGF), and 8-hydroxy-2-deoxyguanosine (8-OHdG) were evaluated with immunohistochemical (IHC) staining. The wound area was significantly reduced in the ESWT and HBOT groups compared to that in the diabetic controls. However, the wound healing time was significantly increased in the HBOT group compared to the ESWT group. Histological findings showed a statistical increase in neovascularization and suppression of the inflammatory response by both HBOT and ESWT compared to the controls. IHC staining revealed a significant increase in Ki-67, VEGF, and eNOS but suppressed 8-OHdG expression in the ESWT group compared to the HBOT group. ESWT facilitated diabetic wound healing more effectively than HBOT by suppressing the inflammatory response and enhancing cellular proliferation and neovascularization and tissue regeneration.

PMID:37658698 | DOI:10.1002/kjm2.12746

Categories
Nevin Manimala Statistics

Long-term risk of recurrent cerebrovascular events after patent foramen ovale closure: Results from a real-world stroke cohort

Eur Stroke J. 2023 Sep 2:23969873231197564. doi: 10.1177/23969873231197564. Online ahead of print.

ABSTRACT

INTRODUCTION: Patent foramen ovale (PFO)-closure is recommended for stroke prevention in selected patients with suspected PFO-associated stroke. However, studies on cerebrovascular event recurrence after PFO-closure are limited by relatively short follow-up periods and information on the underlying aetiology of recurrent events is scarce.

PATIENTS AND METHODS: All consecutive patients with a cerebral ischaemic event and PFO-closure at the University Hospital Graz were prospectively identified from 2004 to 2021. Indication for PFO-closure was based on a neurological-cardiological PFO board decision. Patients underwent standardized clinical and echocardiographic follow-up 6 months after PFO-closure. Recurrent cerebrovascular events were assessed via electronical health records.

RESULTS: PFO-closure was performed in 515 patients (median age: 49 years; Amplatzer PFO occluder: 42%). Over a median follow-up of 11 years (range: 2-18 years, 5141 total patient-years), recurrent ischaemic cerebrovascular events were observed in 34 patients (ischaemic stroke: n = 22, TIA: n = 12) and associated with age, hyperlipidaemia and smoking in multivariable analysis (p < 0.05 each). Large artery atherosclerosis and small vessel disease were the most frequent aetiologies of recurrent stroke/TIA (27% and 24% respectively), and only two events were related to atrial fibrillation (AF). Recurrent ischaemic cerebrovascular event rates and incident AF were comparable in patients treated with different PFO occluders (p > 0.1).

DISCUSSION AND CONCLUSION: In this long-term follow-up-study of patients with a cerebral ischaemic event who had received PFO-closure with different devices, rates of recurrent stroke/TIA were low and largely related to large artery atherosclerosis and small vessel disease. Thorough vascular risk factor control seems crucial for secondary stroke prevention in patients treated for PFO-related stroke.

PMID:37658692 | DOI:10.1177/23969873231197564