Tag: statistics

Eur J Cancer Prev. 2023 Dec 18. doi: 10.1097/CEJ.0000000000000848. Online ahead of print.

ABSTRACT

BACKGROUND: The total coverage of both the Flemish breast cancer and cervical screening program remain suboptimal, with approximately 63% for both. Of all the women invited to the breast cancer screening program, 14.1% never underwent any type of breast cancer screening (any type of mammogram, ultrasound, or clinical breast examination). For the cervical cancer screening, this proportion of ‘never-screeners’ is 12.1%. We conducted two randomized controlled trials to assess whether various communication and presentation styles in the invitation package, were effective at motivating women who had never participated to attend.

METHODS: The study population was limited to never-screeners (women who had never participated in the screening program). The RCT embedded in the breast cancer screening consisted of seven intervention arms and one control arm (all of them included a fixed appointment by letter). The RCT embedded in the cervical cancer screening consisted of three intervention arms and two control arms. In both RCTs, several content and style adaptations were made to the invitation letter, information leaflet, and envelope.

RESULTS: None of the intervention arms in either the breast cancer screening or the cervical cancer screening had a statistically significant impact on the participation rate compared to ‘usual care’ (the regular invitation package used in the screening program).

CONCLUSION: Sending adapted invitation packages to never-screeners, from the Flemish breast and cervical cancer screening program, does not seem to be effective in increasing the proportion of women screened. Innovative methods are needed to motivate never-screeners to be screened.

PMID:38190189 | DOI:10.1097/CEJ.0000000000000848

JAMA Netw Open. 2024 Jan 2;7(1):e2350756. doi: 10.1001/jamanetworkopen.2023.50756.

ABSTRACT

IMPORTANCE: The NAPOLI 3 trial showed the superiority of fluorouracil, leucovorin, liposomal irinotecan, and oxaliplatin (NALIRIFOX) over the combination of gemcitabine and nab-paclitaxel (GEM-NABP) as first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). Analyses comparing NALIRIFOX and GEM-NABP with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) have not yet been reported.

OBJECTIVE: To derive survival, response, and toxic effects data from phase 3 clinical trials and compare NALIRIFOX, FOLFIRINOX, and GEM-NABP.

DATA SOURCES: After a systematic search of PubMed, Scopus, Embase, and American Society of Clinical Oncology and European Society for Medical Oncology meetings’ libraries, Kaplan-Meier curves were extracted from phase 3 clinical trials conducted from January 1, 2011, until September 12, 2023.

STUDY SELECTION: Phase 3 clinical trials that tested NALIRIFOX, FOLFIRINOX, or GEM-NABP as first-line treatment of metastatic PDAC and reported overall survival (OS) and progression-free survival (PFS) curves were selected. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses of Individual Participant Data reporting guidelines.

DATA EXTRACTION AND SYNTHESIS: Individual patient OS and PFS data were extracted from Kaplan-Meier plots of original trials via a graphic reconstructive algorithm. Overall response rates (ORRs) and grade 3 or higher toxic effects rates were also collected. A pooled analysis was conducted, and results were validated via a network meta-analysis.

MAIN OUTCOMES AND MEASURES: The primary end point was OS. Secondary outcomes included PFS, ORR, and toxic effects rates.

RESULTS: A total of 7 trials with data on 2581 patients were analyzed, including 383 patients treated with NALIRIFOX, 433 patients treated with FOLFIRINOX, and 1756 patients treated with GEM-NABP. Median PFS was longer in patients treated with NALIRIFOX (7.4 [95% CI, 6.1-7.7] months) or FOLFIRINOX (7.3 [95% CI, 6.5-7.9] months; [HR], 1.21 [95% CI, 0.86-1.70]; P = .28) compared with patients treated with GEM-NABP (5.7 [95% CI, 5.6-6.1] months; HR vs NALIRIFOX, 1.45 [95% CI, 1.22-1.73]; P < .001). Similarly, GEM-NABP was associated with poorer OS (10.4 [95% CI, 9.8-10.8]; months) compared with NALIRIFOX (HR, 1.18 [95% CI, 1.00-1.39]; P = .05], while no difference was observed between FOLFIRINOX (11.7 [95% CI, 10.4-13.0] months) and NALIRIFOX (11.1 [95% CI, 10.1-12.3] months; HR, 1.06 [95% CI, 0.81-1.39]; P = .65). There were no statistically significant differences in ORR among NALIRIFOX (41.8%), FOLFIRINOX (31.6%), and GEM-NABP (35.0%). NALIRIFOX was associated with lower incidence of grade 3 or higher hematological toxic effects (eg, platelet count decreased 1.6% vs 11.8% with FOLFIRINOX and 10.8% with GEM-NABP), but higher rates of severe diarrhea compared with GEM-NABP (20.3% vs 15.7%).

CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis, NALIRIFOX and FOLFIRINOX were associated with similar PFS and OS as first-line treatment of advanced PDAC, although NALIRIFOX was associated with a different toxicity profile. Careful patient selection, financial toxic effects consideration, and direct comparison between FOLFIRINOX and NALIRIFOX are warranted.

PMID:38190183 | DOI:10.1001/jamanetworkopen.2023.50756

JAMA Intern Med. 2024 Jan 8. doi: 10.1001/jamainternmed.2023.7410. Online ahead of print.

ABSTRACT

IMPORTANCE: Clinical experience suggests that hospital inpatients have become more complex over time, but few studies have evaluated this impression.

OBJECTIVE: To assess whether there has been an increase in measures of hospital inpatient complexity over a 15-year period.

DESIGN, SETTING AND PARTICIPANTS: This cohort study used population-based administrative health data from nonelective hospitalizations from April 1, 2002, to January 31, 2017, to describe trends in the complexity of inpatients in British Columbia, Canada. Hospitalizations were included for individuals 18 years and older and for which the most responsible diagnosis did not correspond to pregnancy, childbirth, the puerperal period, or the perinatal period. Data analysis was performed from July to November 2023.

EXPOSURE: The passage of time (15-year study interval).

MAIN OUTCOMES AND MEASURES: Measures of complexity included patient characteristics at the time of admission (eg, advanced age, multimorbidity, polypharmacy, recent hospitalization), features of the index hospitalization (eg, admission via the emergency department, multiple acute medical problems, use of intensive care, prolonged length of stay, in-hospital adverse events, in-hospital death), and 30-day outcomes after hospital discharge (eg, unplanned readmission, all-cause mortality). Logistic regression was used to estimate the relative change in each measure of complexity over the entire 15-year study interval.

RESULTS: The final study cohort included 3 367 463 nonelective acute care hospital admissions occurring among 1 272 444 unique individuals (median [IQR] age, 66 [48-79] years; 49.1% female and 50.8% male individuals). Relative to the beginning of the study interval, inpatients at the end of the study interval were more likely to have been admitted via the emergency department (odds ratio [OR], 2.74; 95% CI, 2.71-2.77), to have multimorbidity (OR, 1.50; 95% CI, 1.47-1.53) and polypharmacy (OR, 1.82; 95% CI, 1.78-1.85) at presentation, to receive treatment for 5 or more acute medical issues (OR, 2.06; 95% CI, 2.02-2.09), and to experience an in-hospital adverse event (OR, 1.20; 95% CI, 1.19-1.22). The likelihood of an intensive care unit stay and of in-hospital death declined over the study interval (OR, 0.96; 95% CI, 0.95-0.97, and OR, 0.81; 95% CI, 0.80-0.83, respectively), but the risks of unplanned readmission and death in the 30 days after discharge increased (OR, 1.14; 95% CI, 1.12-1.16, and OR, 1.28; 95% CI, 1.25-1.31, respectively).

CONCLUSIONS AND RELEVANCE: By most measures, hospital inpatients have become more complex over time. Health system planning should account for these trends.

PMID:38190179 | DOI:10.1001/jamainternmed.2023.7410

Home Healthc Now. 2024 Jan-Feb 01;42(1):42-51. doi: 10.1097/NHH.0000000000001226.

ABSTRACT

Heart failure (HF) readmissions are common, costly, and often preventable. Despite the implementation of HF programs across clinical settings, rehospitalization is still common. Efforts to identify risk factors for 60-day rehospitalization among HF patients exist, but risk scoring has not been utilized in home healthcare. The purpose of this study was to develop a 60-day rehospitalization risk score for home care patients with HF. This study is a secondary data analysis of a retrospective cross-sectional dataset that was composed of data using the Outcome Assessment Information Set (OASIS)-C version for patients with HF. We computed the Charlson Comorbidity Index (CCI) to use as a confounder. The risk score was computed from the final logistic regression model regression coefficients. The median age was 78 years old, 45.4% were male, and 81.0% were White. We identified 10 significant risk factors including CCI score. The risk score achieved a c-statistic of 0.70 in this patient sample. This risk score could prove useful in clinical practice for guiding attention and decision-making for personalized care of patients with unrecognized or under-treated health needs.

PMID:38190163 | DOI:10.1097/NHH.0000000000001226

Postgrad Med J. 2024 Jan 8:qgad134. doi: 10.1093/postmj/qgad134. Online ahead of print.

ABSTRACT

PURPOSE: Bar charts of numerical data, often known as dynamite plots, are unnecessary and misleading. Their tendency to alter the perception of mean’s position through the within-the-bar bias and their lack of information on the distribution of the data are two of numerous reasons. The machine learning tool, Barzooka, can be used to rapidly screen for different graph types in journal articles.We aim to determine the proportion of original research articles using dynamite plots to visualize data, and whether there has been a change in their use over time.

METHODS: Original research articles in nine surgical fields of research were sampled based on MeSH terms and then harvested using the Python-based biblio-glutton-harvester tool. After harvesting, they were analysed using Barzooka. Over 40 000 original research articles were included in the final analysis. The results were adjusted based on previous validation data with 95% confidence bounds. Kendall τ coefficient with the Mann-Kendall test for significance was used to determine the trend of dynamite plot use over time.

RESULTS: Eight surgical fields of research showed a statistically significant decrease in use of dynamite plots over 10 years. Oral and maxillofacial surgery showed no significant trend in either direction. In 2022, use of dynamite plots, dependent on field and 95% confidence bounds, ranges from ~30% to 70%.

CONCLUSION: Our results show that the use of dynamite plots in surgical research has decreased over time; however, use remains high. More must be done to understand this phenomenon and educate surgical researchers on data visualization practices.

PMID:38190146 | DOI:10.1093/postmj/qgad134

Cell Genom. 2023 Dec 22:100469. doi: 10.1016/j.xgen.2023.100469. Online ahead of print.

ABSTRACT

Epigenetics underpins the regulation of genes known to play a key role in the adaptive and innate immune system (AIIS). We developed a method, EpiNN, that leverages epigenetic data to detect AIIS-relevant genomic regions and used it to detect 2,765 putative AIIS loci. Experimental validation of one of these loci, DNMT1, provided evidence for a novel AIIS-specific transcription start site. We built a genome-wide AIIS annotation and used linkage disequilibrium (LD) score regression to test whether it predicts regional heritability using association statistics for 176 traits. We detected significant heritability effects (average |τ^∗|=1.65) for 20 out of 26 immune-relevant traits. In a meta-analysis, immune-relevant traits and diseases were 4.45× more enriched for heritability than other traits. The EpiNN annotation was also depleted of trans-ancestry genetic correlation, indicating ancestry-specific effects. These results underscore the effectiveness of leveraging supervised learning algorithms and epigenetic data to detect loci implicated in specific classes of traits and diseases.

PMID:38190103 | DOI:10.1016/j.xgen.2023.100469

Oper Neurosurg (Hagerstown). 2024 Jan 8. doi: 10.1227/ons.0000000000001044. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Subpial corticectomy involving complete lesion resection while preserving pial membranes and avoiding injury to adjacent normal tissues is an essential bimanual task necessary for neurosurgical trainees to master. We sought to develop an ex vivo calf brain corticectomy simulation model with continuous assessment of surgical instrument movement during the simulation. A case series study of skilled participants was performed to assess face and content validity to gain insights into the utility of this training platform, along with determining if skilled and less skilled participants had statistical differences in validity assessment.

METHODS: An ex vivo calf brain simulation model was developed in which trainees performed a subpial corticectomy of three defined areas. A case series study assessed face and content validity of the model using 7-point Likert scale questionnaires.

RESULTS: Twelve skilled and 11 less skilled participants were included in this investigation. Overall median scores of 6.0 (range 4.0-6.0) for face validity and 6.0 (range 3.5-7.0) for content validity were determined on the 7-point Likert scale, with no statistical differences between skilled and less skilled groups identified.

CONCLUSION: A novel ex vivo calf brain simulator was developed to replicate the subpial resection procedure and demonstrated face and content validity.

PMID:38190098 | DOI:10.1227/ons.0000000000001044

High Blood Press Cardiovasc Prev. 2024 Jan 8. doi: 10.1007/s40292-023-00616-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Safety studies of anticoagulant therapy have so far been conducted on many subjects in controlled conditions (i.e., clinically monitored) and demonstrated the noninferiority of new ones over old anticoagulant drugs. Data on the propositions for the presence of symptoms and signs of bleeding among various anticoagulants in the emergency department indicate that these data do not match the data published so far.

AIM: The aim of the study was to investigate the differences in the frequency of bleeding and bleeding-related symptoms as a reason for emergency department attendance in patients on anticoagulant therapy.

METHODS: The study included patients from the emergency department of University Hospital for one year, who were on anticoagulant therapy and who met the inclusion criteria. Out of a total of 595 patients, 409 were on warfarin (68.74%), and the rest were taking direct oral anticoagulants (DOAC): dabigatran 71 (11.93%), rivaroxaban 66 (11.09%) and apixaban 49 (8.23%).

RESULTS: Out of 409 patients taking warfarin, 34.4% were adequately anticoagulated with the frequency of bleeding 13.7%, while in 57.2% of patients, PT INR was higher than the reference values with the frequency of bleeding 15.0%. A comparison between all DOAC groups and adequately anticoagulated warfarin patients in the frequency of bleeding and bleeding-related symptoms as a reason for emergency attendance yielded a difference that was marginally statistically significant (Pearson Chi-Square = 7.554, p = 0.052).

CONCLUSION: Monitoring the frequency of bleeding and bleeding-related symptoms in patients on oral anticoagulant therapy as a reason for emergency department attendance may be a new safety and efficacy factor in real-life patient scenarios.

PMID:38190093 | DOI:10.1007/s40292-023-00616-y

CNS Drugs. 2024 Jan 8. doi: 10.1007/s40263-023-01056-x. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Identifying key factors for a successful transition from once-monthly paliperidone palmitate (PP1M) to three-monthly paliperidone palmitate (PP3M) is crucial for improving treatment outcomes, enhancing patient adherence, and reducing relapse risk in patients with schizophrenia. Providing region-specific insights for evidence-based clinical decisions can aid clinicians in optimizing transition strategies for Chinese patients with schizophrenia. Therefore, the objective of this post hoc analysis of a double-blind parallel-group multicenter phase 3 study (NCT01515423) was to identify factors related to the disease stabilization that may allow for a successful transition from PP1M to PP3M in the treatment of Chinese patients with schizophrenia.

METHODS: Adults (18-70 years) diagnosed with schizophrenia using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition text revision, for over 1 year and with a baseline Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 were entered into an open-label (OL) phase receiving PP1M for 17 weeks. After the 17-week OL phase, patients who met the criteria necessary for stabilization were randomized (1:1) to PP1M (fixed-dose, 50, 75, 100, or 150 mg eq.) or PP3M (fixed-dose, 175, 263, 350, or 525 mg eq.) in a 48-week double-blind phase. Stabilization was defined as a PANSS total score < 70, PANSS item (P1, P2, P3, P6, P7, G8, G14) scores ≤ 4, and a reduction in Clinical Global Impression Severity (CGI-S) score of ≥ 1 from OL baseline. This post hoc analysis evaluated changes and trends in symptom severity using PANSS, changes in mental states using CGI-S, and changes in personal and social functioning using Personal and Social Performance (PSP) scores from baseline to the endpoint of the OL phase in patients who either met or did not meet the stabilization criteria (stabilized versus non-stabilized group). Comparison of changes and trends in the clinical scores between the stabilized group and non-stabilized group were conducted using linear mixed model and Mann-Kendall trend analysis, respectively. Univariate and multivariate logistic regression analyses were conducted to explore factors associated with stabilization status for transition.

RESULTS: Of 296 patients enrolled, 210 achieved disease stabilization (106 patients and 104 patients were randomized to PP1M and PP3M, respectively). Significant downward trends in the PANSS and CGI-S scores were detected in the stabilized patients (n = 210, Z_PANSS = -2.21, p = 0.028; Z_CGI-S = -2.21, p = 0.028) but not in the non-stabilized patients (n = 86). No significant trends in the PSP scores were observed in either group. The factors significantly associated with disease stabilization were the CGI-S score at baseline [odds ratio (OR) = 0.22, 95% confidence interval (CI): 0.09, 0.5), reduction of the PANSS score at week 13 (OR = 1.11, 95% CI: 1.06, 1.17), and reduction of CGI-S score at week 13 (OR = 2.27, 95% CI: 1.03, 5.02).

CONCLUSION: A lower CGI-S total score at baseline and greater reductions in PANSS and CGI-S scores at week 13 were associated with patients achieving disease stabilization, that may allow for a successful transition. Evidence from this study indicates that better disease condition at baseline, early functional improvement and symptomatic relief were the key factors associated with disease stabilization. The findings may guide clinicians to identify suitable patients for transition from PP1M to PP3M and further optimize the use of PP3M in China.

CLINICAL TRIALS REGISTRATION: EudraCT number: 2011-004889-15 and ClinicalTrials.gov (identifier: NCT01515423) for the original double-blind randomized study.

PMID:38190077 | DOI:10.1007/s40263-023-01056-x

J Epidemiol Glob Health. 2024 Jan 8. doi: 10.1007/s44197-023-00175-4. Online ahead of print.

ABSTRACT

Maternal and paternal age at birth is increasing globally. Maternal age may affect perinatal outcomes, but the effect of paternal age and its joint effect with maternal age are not well established. This prospective, multicenter, cohort analysis used data from the University Hospital Advanced Age Pregnant Cohort Study in China from 2016 to 2021, to investigate the separate association of paternal age and joint association of paternal and maternal age with adverse perinatal outcomes. Of 16,114 singleton deliveries, mean paternal and maternal age (± SD) was 38.0 ± 5.3 years and 36.0 ± 4.1 years. In unadjusted analyses, older paternal age was associated with increased risks of gestational diabetes mellitus (GDM), hypertensive disorders of pregnancy, preeclampsia, placenta accreta spectrum disorders, placenta previa, cesarean delivery (CD), and postpartum hemorrhage, preterm birth (PTB), large-for-gestational-age, macrosomia, and congenital anomaly, except for small-for-gestational-age. In multivariable analyses, the associations turned to null for most outcomes, and attenuated but still significant for GDM, CD, PTB, and macrosomia. As compare to paternal age of < 30 years, the risks in older paternal age groups increased by 31-45% for GDM, 17-33% for CD, 32-36% for PTB, and 28-31% for macrosomia. The predicted probabilities of GDM, placenta previa, and CD increased rapidly with paternal age up to thresholds of 36.4-40.3 years, and then plateaued or decelerated. The risks of GDM, CD, and PTB were much greater for pregnancies with younger paternal and older maternal age, despite no statistical interaction between the associations related to paternal and maternal age. Our findings support the advocation that paternal age, besides maternal age, should be considered during preconception counseling.Trial Registration NCT03220750, Registered July 18, 2017-Retrospectively registered, https://classic.clinicaltrials.gov/ct2/show/NCT03220750 .

PMID:38190051 | DOI:10.1007/s44197-023-00175-4