Tag: statistics

J Clin Oncol. 2023 Nov 1:JCO2300914. doi: 10.1200/JCO.23.00914. Online ahead of print.

ABSTRACT

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The phase III, double-blind KEYNOTE-826 trial of pembrolizumab 200 mg or placebo once every 3 weeks for up to 35 cycles plus platinum-based chemotherapy, with or without bevacizumab, showed statistically significant survival benefits with the addition of pembrolizumab for patients with persistent, recurrent, or metastatic cervical cancer (primary data cutoff: May 3, 2021). This article reports the protocol-specified final overall survival (OS) results tested in the PD-L1 combined positive score (CPS) ≥1, all-comer, and CPS ≥10 populations. At the final data cutoff (October 3, 2022), the median study follow-up duration was 39.1 months (range, 32.1-46.5 months). In the PD-L1 CPS ≥1 (N = 548), all-comer (N = 617), and CPS ≥10 (N = 317) populations, median OS with pembrolizumab-chemotherapy versus placebo-chemotherapy was 28.6 months versus 16.5 months (hazard ratio [HR] for death, 0.60 [95% CI, 0.49 to 0.74]), 26.4 months versus 16.8 months (HR, 0.63 [95% CI, 0.52 to 0.77]), and 29.6 months versus 17.4 months (HR, 0.58 [95% CI, 0.44 to 0.78]), respectively. The incidence of grade ≥3 adverse events was 82.4% with pembrolizumab-chemotherapy and 75.4% with placebo-chemotherapy. These results show that pembrolizumab plus chemotherapy, with or without bevacizumab, continued to provide clinically meaningful improvements in OS for patients with persistent, recurrent, or metastatic cervical cancer.

PMID:37910822 | DOI:10.1200/JCO.23.00914

Eye Contact Lens. 2023 Nov 1. doi: 10.1097/ICL.0000000000001051. Online ahead of print.

ABSTRACT

OBJECTIVES: To report patient-reported experiences with dry eye disease and therapeutic contact lenses.

METHODS: A survey was distributed to patients with dry eye disease. Demographics, Ocular Surface Disease Index (OSDI), systemic disease, contact lens history, and burden of care information were collected. Descriptive statistics are presented and categorized by nonlens, soft lens, and scleral lens (SL) wearers.

RESULTS: Of 639 respondents, 15% (94/639) were currently using therapeutic soft or SLs (47 soft and 69 SL). Mid-day fogging or clouding of vision was reported by SL (75%, 50/67) and soft lens (62%, 29/47) wearers. Seventy-two percent of SL wearers spent more than 20 min daily on dry eye treatment while 43% of soft lens wearers spent more than 20 min. Median annual expenditure was higher for SL ($1,500, n=63) than nonlens ($500, n=371) or soft lens wearers ($700, n=43). Mean OSDI scores in all groups were in the severe category (51±22 years, n=401 nonlens wearers; mean age; 45±22 years, n=47 soft lens wearers; 60±24 years, n=69 SL wearers).

CONCLUSIONS: Mid-day fogging and blurring of vision was reported by most of the individuals using therapeutic lenses for dry eye disease. SL wearers allocate the most resources for dry eye care.

PMID:37910817 | DOI:10.1097/ICL.0000000000001051

J Ocul Pharmacol Ther. 2023 Nov 1. doi: 10.1089/jop.2023.0080. Online ahead of print.

ABSTRACT

Purpose: This study was intended to characterize the impact of meibomian gland dysfunction (MGD) on patients’ quality of life. Methods: In this prospective, multicenter, noninterventional clinical study (NCT01979887), eligible individuals (age ≥40 years; absence of uncontrolled ocular/systemic disease) were categorized, based on composite grading of ocular symptoms, Schirmer score, and meibum quality, into (1) non-MGD, (2) mild/moderate MGD, or (3) severe MGD cohorts. The MGD Impact Questionnaire (MGD IQ), a 10-item patient-reported outcome measure, was self-administered at clinic visit on day 1, and readministered on day 22 to assess intervisit agreement regarding MGD IQ responses. Results: In total, 75 subjects were assigned to the study cohorts (25 per cohort). Across cohorts, MGD IQ item scores rose incrementally with increasing MGD severity. The severe MGD cohort experienced greater difficulty with reading and performance of leisure activities, greater time on eye care, and greater bother with eye care and eye appearance than the mild/moderate MGD cohort (all P < 0.05). Compared with the non-MGD cohort, the mild/moderate MGD cohort had greater difficulty working on computer, whereas the severe MGD cohort had greater difficulty reading, driving, and performing leisure activities, more frequent difficulty with outdoor activities, more time on eye care, and greater bother with eye care (all P < 0.05). Intervisit agreement between MGD IQ responses was fair to moderate (weighted kappa statistic 0.33‒0.58). Conclusions: Vision-related activities are negatively impacted by increasing severity of MGD. The MGD IQ instrument can help characterize disease severity and amplify the patient’s voice in patient-centric clinical research. ClinicalTrials.gov NCT01979887.

PMID:37910805 | DOI:10.1089/jop.2023.0080

Photobiomodul Photomed Laser Surg. 2023 Oct 31. doi: 10.1089/photob.2023.0066. Online ahead of print.

ABSTRACT

Objective: This systematic review and meta-analysis aimed to assess the influence of laser treatment on adhesive bonding of liners to polymethyl methacrylate (PMMA) denture base resins. Methods: The focused question was: “Does the application of laser treatment (Intervention) influence the adhesive bonding strength (Outcome) of liners to PMMA denture base resins (Population) as compared with untreated or unconditioned surfaces (Control)?” In vitro and clinical reports as well as reports on influence of laser treatments on bonding strength of liners to PMMA denture resins in comparison with untreated surfaces were included. Reports without any control group[s], without any application of laser[s] for PMMA denture bases that did not utilize PMMA denture bases, and not evaluate bond strength of PMMA denture base resins were excluded. An electronic search was conducted on PubMed, Scopus, and Web of Science. Meta-analyses were performed for calculating the standard mean difference (SMD) with a 95% confidence interval (95% CI). Results: Nine of the 12 included studies found that laser irradiation treatment produced significant surface texture alterations of the PMMA denture base and improved the adhesion between the PMMA denture base and soft lining. According to the meta-analysis, tensile bond strength showed an SMD of -2.49% (95% CI: -3.89 to -1.08; p = 0.0005), suggesting a statistically significant difference between the control and test groups (i.e., favoring laser-treated samples than untreated samples). Regarding shear bond strength scores, the outcomes showed an SMD of -2.24% (95% CI: -3.79 to -0.69; p = 0.005), suggesting a statistically significant difference between the control and test groups (i.e., favoring laser-treated samples than untreated samples). Conclusions: Despite the high heterogeneity among the included studies, it can be concluded that laser treatment might improve the bonding strengths of liners to PMMA denture base resins as compared with untreated surfaces. To validate the aforementioned conclusions, further verification is required through the implementation of well-designed randomized controlled trials with large sample sizes.

PMID:37910776 | DOI:10.1089/photob.2023.0066

Opt Lett. 2023 Nov 1;48(21):5519-5522. doi: 10.1364/OL.501346.

ABSTRACT

Free-space optical transmission through the Earth’s atmosphere is applicable to high-speed data transmission and optical clock comparisons, among other uses. Fluctuations in the refractive index of the atmosphere limit the performance of atmospheric optical transmission by inducing phase noise, angle-of-arrival variation, and scintillation. The statistics of these deleterious effects are predicted by models for the spatial spectrum of the atmospheric refractive index structure. We present measurements of phase fluctuations, angle-of-arrival variations, and scintillation, taken concurrently and compared with models for the atmospheric refractive index structure. The measurements are also cross-compared by deriving independent estimates of the turbulence structure constant $C_n^2$. We find agreement within an order of magnitude for derived $C_n^2$ values for all three metrics.

PMID:37910692 | DOI:10.1364/OL.501346

J Proteome Res. 2023 Nov 1. doi: 10.1021/acs.jproteome.3c00496. Online ahead of print.

ABSTRACT

Alzheimer’s disease (AD) is the most prevalent form of dementia, disproportionately affecting women in disease prevalence and progression. Comprehensive analysis of the serum proteome in a common AD mouse model offers potential in identifying possible AD pathology- and gender-associated biomarkers. Here, we introduce a multiplexed, nondepleted mouse serum proteome profiling via tandem mass-tag (TMTpro) labeling. The labeled sample was separated into 475 fractions using basic reversed-phase liquid chromatography (RPLC), which were categorized into low-, medium-, and high-concentration fractions for concatenation. This concentration-dependent concatenation strategy resulted in 128 fractions for acidic RPLC-tandem mass spectrometry (MS/MS) analysis, collecting ∼5 million MS/MS scans and identifying 3972 unique proteins (3413 genes) that cover a dynamic range spanning at least 6 orders of magnitude. The differential expression analysis between wild type and the commonly used AD model (5xFAD) mice exhibited minimal significant protein alterations. However, we detected 60 statistically significant (FDR < 0.05), sex-specific proteins, including complement components, serpins, carboxylesterases, major urinary proteins, cysteine-rich secretory protein 1, pregnancy-associated murine protein 1, prolactin, amyloid P component, epidermal growth factor receptor, fibrinogen-like protein 1, and hepcidin. The results suggest that our platform possesses the sensitivity and reproducibility required to detect sex-specific differentially expressed proteins in mouse serum samples.

PMID:37910662 | DOI:10.1021/acs.jproteome.3c00496

Dermatol Surg. 2023 Oct 30. doi: 10.1097/DSS.0000000000003991. Online ahead of print.

NO ABSTRACT

PMID:37910652 | DOI:10.1097/DSS.0000000000003991

JMIR Res Protoc. 2023 Nov 1;12:e51505. doi: 10.2196/51505.

ABSTRACT

BACKGROUND: There is a tendency nowadays to restore large defects in primary dentition with pediatric crowns instead of conventional restorations. Thus, understanding the factors contributing to the survival or failure of dental crowns in pediatric dentistry is essential for optimizing treatment outcomes.

OBJECTIVE: The primary objective of this protocol is to outline the methodological approach for analyzing data from observational studies and randomized controlled trials to investigate reasons for the failure of dental crowns in primary teeth and to compute their survival and failure rates.

METHODS: A comprehensive literature review will be performed in electronic databases, including PubMed (MEDLINE), Cochrane, Embase, and Web of Science. As per predefined inclusion criteria, we will include observational studies (prospective clinical studies) and randomized clinical trials that have an English abstract and involve children aged 1-10 years undergoing crown restorations. Two independent reviewers will independently screen all retrieved records and full-text articles and extract data. The study’s methodological quality will be appraised using suitable tools. Assessments of publication bias will be performed using funnel plots. The findings will be described qualitatively for the systematic review. If possible, a meta-analysis will be performed to estimate failure rates by dividing the number of failures by the total exposure time. A Poisson regression model, assuming constant event rates, will be used to compute 3-year and 5-year survival proportions. The Pearson goodness-of-fit statistics will be used to assess the heterogeneity of the model. A P value <.05 will be considered significant. All analyses will be performed using R Statistical software (version 4.1.2; R Core Team).

RESULTS: This systematic review and synthesis aim to assess the survival and failure rates of dental crowns in pediatric dentistry. By following this rigorous methodology, we seek to provide valuable insights into the factors contributing to the success or failure of these restorations. The results of our full review will have implications for pediatric dentists, researchers, and policy makers, helping to improve dental care for children.

CONCLUSIONS: This systematic review protocol helps in establishing a thorough approach for reviewing failures in pediatric crowns. By following this methodology, standardization and transparency of the process as well as accountability for the stated methods and outcomes will be ensured. The findings of this review and analysis will provide useful data on the survival of crowns to pediatric dentists and researchers.

TRIAL REGISTRATION: PROSPERO CRD42023442266; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=442266.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51505.

PMID:37910174 | DOI:10.2196/51505

JMIR Hum Factors. 2023 Nov 1;10:e50891. doi: 10.2196/50891.

ABSTRACT

BACKGROUND: Health care professionals, particularly those in surgical settings, face high stress levels, impacting their well-being. Traditional monitoring methods, like using Holter electrocardiogram monitors, are impractical in the operating room, limiting the assessment of physicians’ health. Wrist-worn heart rate monitors, like the Apple Watch, offer promise but are restricted in surgeries due to sterility issues.

OBJECTIVE: This study aims to assess the feasibility and accuracy of using an upper arm-worn Apple Watch for heart rate monitoring during robotic-assisted surgeries, comparing its performance with that of a wrist-worn device to establish a reliable alternative monitoring site.

METHODS: This study used 2 identical Apple Watch Series 8 devices to monitor the heart rate of surgeons during robotic-assisted surgery. Heart rate data were collected from the wrist-worn and the upper arm-worn devices. Statistical analyses included calculating the mean difference and SD of difference between the 2 devices, constructing Bland-Altman plots, assessing accuracy based on mean absolute error and mean absolute percentage error, and calculating the intraclass correlation coefficient.

RESULTS: The mean absolute errors for the whole group and for participants A, B, C, and D were 3.63, 3.58, 2.70, 3.93, and 4.28, respectively, and the mean absolute percentage errors were 3.58%, 3.34%, 2.42%, 4.58%, and 4.00%, respectively. Bland-Altman plots and scatter plots showed no systematic error when comparing the heart rate measurements obtained from the upper arm-worn and the wrist-worn Apple Watches. The intraclass correlation coefficients for participants A, B, C, and D were 0.559, 0.651, 0.508, and 0.563, respectively, with a significance level of P<.001, indicating moderate reliability.

CONCLUSIONS: The findings of this study suggest that the upper arm is a viable alternative site for monitoring heart rate during surgery using an Apple Watch. The agreement and reliability between the measurements obtained from the upper arm-worn and the wrist-worn devices were good, with no systematic error and a high level of accuracy. These findings have important implications for improving data collection and management of the physical and mental demands of operating room staff during surgery, where wearing a watch on the wrist may not be feasible.

PMID:37910162 | DOI:10.2196/50891

JMIR Med Educ. 2023 Nov 1;9:e51421. doi: 10.2196/51421.

ABSTRACT

BACKGROUND: Artificial intelligence (AI) is a rapidly developing field with the potential to transform various aspects of health care and public health, including medical training. During the “Hygiene and Public Health” course for fifth-year medical students, a practical training session was conducted on vaccination using AI chatbots as an educational supportive tool. Before receiving specific training on vaccination, the students were given a web-based test extracted from the Italian National Medical Residency Test. After completing the test, a critical correction of each question was performed assisted by AI chatbots.

OBJECTIVE: The main aim of this study was to identify whether AI chatbots can be considered educational support tools for training in public health. The secondary objective was to assess the performance of different AI chatbots on complex multiple-choice medical questions in the Italian language.

METHODS: A test composed of 15 multiple-choice questions on vaccination was extracted from the Italian National Medical Residency Test using targeted keywords and administered to medical students via Google Forms and to different AI chatbot models (Bing Chat, ChatGPT, Chatsonic, Google Bard, and YouChat). The correction of the test was conducted in the classroom, focusing on the critical evaluation of the explanations provided by the chatbot. A Mann-Whitney U test was conducted to compare the performances of medical students and AI chatbots. Student feedback was collected anonymously at the end of the training experience.

RESULTS: In total, 36 medical students and 5 AI chatbot models completed the test. The students achieved an average score of 8.22 (SD 2.65) out of 15, while the AI chatbots scored an average of 12.22 (SD 2.77). The results indicated a statistically significant difference in performance between the 2 groups (U=49.5, P<.001), with a large effect size (r=0.69). When divided by question type (direct, scenario-based, and negative), significant differences were observed in direct (P<.001) and scenario-based (P<.001) questions, but not in negative questions (P=.48). The students reported a high level of satisfaction (7.9/10) with the educational experience, expressing a strong desire to repeat the experience (7.6/10).

CONCLUSIONS: This study demonstrated the efficacy of AI chatbots in answering complex medical questions related to vaccination and providing valuable educational support. Their performance significantly surpassed that of medical students in direct and scenario-based questions. The responsible and critical use of AI chatbots can enhance medical education, making it an essential aspect to integrate into the educational system.

PMID:37910155 | DOI:10.2196/51421