Statistical Power Analysis Research Articles

Testing biasedness of self-reported microbusiness innovation in the annual business survey.

This study tests for potential bias in self-reported innovation due to the inclusion of a research and development (R&D) module that only microbusinesses (less than 10 employees) receive in the Annual Business Survey (ABS). Previous research found that respondents to combined innovation/R&D surveys reported innovation at lower rates than respondents to innovation-only surveys. A regression discontinuity design is used to test whether microbusinesses, which constitute a significant portion of U.S. firms with employees, are less likely to report innovation compared to other small businesses. In the vicinity of the 10-employee threshold, the study does not detect statistically significant biases for new-to-market and new-to-business product innovation. Statistical power analysis confirms the nonexistence of biases with a high power. Comparing the survey design of ABS to earlier combined innovation/R&D surveys provides valuable insights for the proposed integration of multiple Federal surveys into a single enterprise platform survey. The findings also have important implications for the accuracy and reliability of innovation data used as an input to policymaking and business development strategies in the United States.

Experimental and Statistical Study of Flexural Strength in Ternary Blended High-Performance Concrete using Alcofine

The primary aim of this research is to conduct a comprehensive comparative experimental and statistical study on the flexural strength of a novel ternary blended high-performance M30 grade concrete incorporating 20% Alcofine in comparison to traditional concrete.The components employed in the experimental investigation of high-performance M30 concrete incorporating Alcofine, in contrast to conventional concrete, comprise cement, fine aggregate, coarse aggregate, water, Alcofine, and additional cementitious materials like fly ash and silica fume. The Flexural Strength of high-performance M30 concrete containing Alcofine significantly influences the performance of concrete structures, rendering it a critical mechanical property for examination in the comparative analysis. The mean flexural strength of the Conventional Concrete group measured 8.1111 N/mm^2, with a standard deviation of 0.75840 and a standard error of the mean of 0.17876. In contrast, the Ternary Blended Concrete group exhibited a higher mean flexural strength of 12.5000 N/mm^2, coupled with a larger standard deviation of 2.09341 and a standard error of the mean of 0.49342. The statistical power analysis, involving parameters such as alpha (α) and beta (β), with commonly used values of 0.05 or 0.01, indicates a significance level of 5% or 1%, respectively. Further research could delve into refining the optimal percentage of Alcofine and exploring its long-term performance under varying environmental conditions. Keywords: Ternary Blended Concrete; Alcofine; Flexural Strength; Comparative Analysis; Statistical Study

ANALYSIS OF THERMAL PERFORMANCE IN A TWO-PHASE THERMOSYPHON LOOP BASED ON FLOW VISUALIZATION AND AN IMAGE PROCESSING TECHNIQUE

Thermal performance was analyzed based on flow visualization and an image processing technique in a two-phase thermosyphon loop (TPTL) with boiling water as the working fluid at low pressure. The bubble geometries, bubble frequency, and dynamic void fraction were estimated using direct image analysis combined with the power spectrum and statistical analysis. At a heating rate of 400 W and a filling ratio of 0.88, the thermal performance of the TPTL was enhanced with a thermal efficiency of 91% and effective thermal conductivity of 11,336 Wm<sup>-1</sup> °C<sup>-1</sup>. The enhancement was due to the higher frequency cap bubble flow of 11.2 Hz obtained by the direct flow visualization. The bigger Taylor bubbles with slug flow were examined to contribute to the negative effect on the heat transfer rate due to their film boiling regimes. The detailed analysis reveals the mechanism of bubble flow interacting with thermal performance.

Adaptive thresholding increases sensitivity to detect changes in the rate of skin conductance responses to psychologically arousing stimuli in both laboratory and ambulatory settings

Psychophysiologists recording electrodermal activity (EDA) often derive measures of slow, tonic activity—skin conductance level (SCL)—and faster, more punctate changes—skin conductance responses (SCRs). A SCR is conventionally considered to have occurred when the local amplitude of the EDA signal exceeds a researcher-determined threshold (e.g., 0.05 μS), typically fixed across study participants and conditions. However, fixed SCR thresholds can preferentially exclude data from individuals with low SCL because their SCRs are smaller on average, thereby reducing statistical power for group-level analyses. Thus, we developed a fixed plus adaptive (FA) thresholding method that adjusts identification of SCRs based on an individual's SC at the onset of the SCR to increase statistical power and include data from more participants. We assess the utility of applying FA thresholding across two independent samples and explore age and race-related associations with EDA outcomes. Study 1 uses wired EDA measurements from 254 healthy adults responding to evocative images and sounds in a laboratory setting. Study 2 uses wireless EDA measurements from 20 children with autism in a clinical environment while they completed behavioral tasks. Compared to a 0.01, 0.03, and 0.05 μS fixed threshold, FA thresholding at 1.9% modestly increases statistical power to detect a difference in SCR rate between tasks with higher vs. lower subjective arousal and reduces exclusion of participants by up to 5% across both samples. This novel method expands the EDA analytical toolbox and may be useful in populations with highly variable basal SCL or when comparing groups with different basal SCL. Future research should test for reproducibility and generalizability in other tasks, samples, and contexts. Impact statementsThis article is important because it introduces a novel method to enhance sensitivity and statistical power in analyses of skin conductance responses from electrodermal data.

ELECTRONIC TAXATION AND TAX YIELD A PRE AND POST COMPARATIVE ANALYSIS

This scholarly inquiry delves into the intricate interplay among digital taxation and the consequential tax yield. The primary aim of this article is to discern the diverse methodologies by which digital tax systems can be safeguarded and maintained in Nigeria, while also exploring strategies to prevent and mitigate instances of cyber tax crimes. This endeavor is informed by the invaluable insights and lessons garnered from the experiences of other nations in their resolute battle against digital tax fraud. The concept of tax-equivalent yield pertains to the calculation of the rate of return that a taxable bond must attain in order to be on par with the yield generated by a corresponding tax-exempt municipal bond. The process of calculation serves as a valuable instrument for investors to discern and evaluate the disparities in returns between a tax-exempt investment and its taxable counterpart. A cross-sectional research design was used with a sample size determined by statistical power analysis. Secondary data was obtained from the National Bureau of Statistics and analyzed utilizing appropriate statistical techniques, including regression analysis. The model specification indicates that electronic taxation revenue has a favorable but not substantial outcome on economic expansion, while government spending has an unfavorable but insignificant impact on economic growth. The R2 of .852 suggests that the model elucidates 85.2% of the variance in GDP growth, which is a relatively high amount of variance explained. The study concludes that electronic taxation and government spending may have some impact on economic growth, but the effect is not statistically significant. The paper recommends conducting more research to identify other factors that may have a substantial influence on economic growth, improving electronic tax collection methods, and improving the effectiveness and efficiency of government spending. Policymakers should consider both statistical significance and practical significance when making decisions based on empirical research.

HJKC3-007: Outcomes of Patients with Chronic Myeloid Leukemia in Chronic Phase Treated with Asciminib and Other Tyrosine Kinase Inhibitors in Routine Clinical Practice

Background and significance: There are typically high response rates to first line TKI therapies in chronic phase chronic myeloid leukemia (CP-CML). However, responses in later lines (second line and beyond) are diminished and highly dependent on the specific tyrosine kinase inhibitors (TKIs) used. Asciminib received FDA approval in October 2021 for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) CML-CP who were previously treated with two or more TKIs, and in patients with Ph+ CML-CP with the T315I mutation. Our goal in this study is to evaluate the role of asciminib therapy for patients with CML beyond clinical studies, in routine clinical practice. Study Design and methods: Data for this study will be abstracted from the HJKC3 (H. Jean Khoury Cure CML Consortium) CML registry project (HJKC3-0005); the HJKC3 CML Registry is a collaborative academic multi-site registry. Patients will be consented to allow collection of both retrospective and prospective data for the HJKC3 CML Registry. The data forms and surveys will be built and managed through the Research Electronic Data Capture (REDCap), a secure web application managed by the Clinical & Translational Science Institute. Participating sites include members of the HJKC3 (curecml.org). This study will be an opportunity to evaluate asciminib usage in ‘real-world’ academic practices across the United States. This observational study will include cohorts of patients diagnosed with CP-CML previously treated with two or more tyrosine kinase inhibitors and/or receiving asciminib and/or those with a T315I mutation, not currently enrolled in a randomized controlled trial. The HJKC3 CML Registry intends to collect clinical and patient reported outcome (PRO) data. After obtaining patient consent, patients will be invited to complete PRO assessments. The study will attempt to collect PRO data regardless of disease or treatment status. PRO assessments will be primarily administered online, though study staff will offer alternatives (e.g., phone) for participants without internet access. Study subjects will be emailed a link to access a secure platform hosted by one of the study sites, Medical College of Wisconsin (MCW), using the REDCap platform. Study Objectives: The primary objective of the study is to describe characteristics of patients who were previously treated with two or more TKIs and treated with asciminib or with any other TKIs. The secondary objectives are to describe the clinical outcomes and PRO of those patients. Exploratory objectives include description of characteristics, treatment outcome and PRO for patients with T315I mutation. Statistical plan: The sample size of approximately 225 participants during the 5-year recruitment period is based on the available clinical expertise and ongoing recruitment data in the HJKC3 CML registry in lieu of statistical power analysis. We estimate that 150 patients in the HJKC3 CML registry will be treated with other TKI and 75 treated with asciminib. Among a total of 225 patients, we estimate that 75 patients with the T315I mutation will be enrolled in the registry. No formal statistical inference will be drawn to compare the outcomes between these two groups. Bayesian predictive probability (PP) will be utilized for the exploratory analysis of Major Molecular Response (MMR). Survival probabilities will be computed using the Kaplan-Meier method, and the p-values from the log-rank test will be provided. Different PRO domains of the patient's symptoms and functioning will be analyzed separately (e.g., depression separate from fatigue, separate from GI symptoms, etc.) since combining them into a summary score may dilute the effects of the individual (and not necessarily related) components and mask actual change. The main objective for the analyses of PRO data from the registry is to describe any differences by treatment type in patients treated with asciminib and other TKIs.

Federated statistical analysis: non-parametric testing and quantile estimation

The age of big data has fueled expectations for accelerating learning. The availability of large data sets enables researchers to achieve more powerful statistical analyses and enhances the reliability of conclusions, which can be based on a broad collection of subjects. Often such data sets can be assembled only with access to diverse sources; for example, medical research that combines data from multiple centers in a federated analysis. However these hopes must be balanced against data privacy concerns, which hinder sharing raw data among centers. Consequently, federated analyses typically resort to sharing data summaries from each center. The limitation to summaries carries the risk that it will impair the efficiency of statistical analysis procedures. In this work, we take a close look at the effects of federated analysis on two very basic problems, non-parametric comparison of two groups and quantile estimation to describe the corresponding distributions. We also propose a specific privacy-preserving data release policy for federated analysis with the K-anonymity criterion, which has been adopted by the Medical Informatics Platform of the European Human Brain Project. Our results show that, for our tasks, there is only a modest loss of statistical efficiency.

Addressing challenges to carrying out intervention programs with youth populations: Successes and strategies.

We identify five challenges notoriously faced by researchers conducting youth intervention studies: access to the target population, successful recruitment, ensuring continued attendance, promoting engaged, enthused, and task-focused participation, and efficient data collection. To ensure research quality, we have devised strategies to address these obstacles. Successes and lessons are included from The Compass Project (TCP), a 9-week morality strengthening program designed to facilitate positive attitudinal and behavioral outcomes in young people. Despite four of the five identified challenges being overcome in TCP, the fifth challenge of data collection was insurmountable as many participants failed to complete questionnaire scales. We propose that researchers build on our success by building rapport and trust with participants and youth organizations and building a participant sense of community, and improve upon our design by scrutinizing the format, accessibility, and length of data measures. Ultimately, tests of whether intervention programs can result in positive outcomes in the lives of young people hinge on adequately overcoming the identified challenges. Implementation of the proposed strategies will be instrumental to allow for meaningful and powerful statistical analyses to more accurately gauge the positive impact of intervention programs on young people's lives.

The Effect of Smartphone Uses and Parenting Style on the Honest Character and Responsibility of Elementary School Students

This study aims to analyze the effect of parenting and smartphone use on the honest and responsible attitude of Tipar Public Elementary School students. This study used a quantitative method with a survey method to investigate the relationship between smartphone use, parenting style, and the development of honest character and responsibility among elementary school students. Questionnaires were employed to collect data. The participants in this study were elementary school students. Tipar Elementary School will be chosen as a representative sample, and the sample size will be calculated based on statistical considerations and power analysis. The collected data were examined using relevant statistical techniques. This study reveals that parenting style positively affected students' honest and responsible attitudes by 26.3%. Smartphone use positively affects students' open and accountable attitudes by 24.0%. Parenting style has a positive effect on smartphone use, amounted 19.1%. Parenting parents and smartphones positively influence the honest and responsible mood of Tipar Public Elementary School students, 34.9%, and other factors influence the remaining 66.1%. As a result, the more positive parents' attitudes toward their children, the more honest and responsible students become. The greater students use smartphones, the better their open mindset and responsibility. Similarly, the better the parenting style and the usage of smartphones, the better students’ honesty and responsibility. In contrast, the more severe the parenting style and the use of smartphones, the lower the students' open thinking and responsibility would be.

Experimental Design and Power for Moderation in Multisite Cluster Randomized Trials

Multisite cluster randomized trials (MCRTs), in which, the intermediate-level clusters (e.g., classrooms) are randomly assigned to the treatment or control condition within each site (e.g., school), are among the most commonly used experimental designs across a broad range of disciplines. MCRTs often align with the theory that programs are delivered at a cluster-level (e.g., teacher professional development) and provide opportunities to explore treatment effect heterogeneity across sites. In designing experimental studies, a critical step is the statistical power analysis and sample size determination. However, the statistical tools for power analysis of moderator effects in three-level MCRTs are not available. In this study, we derived formulas for calculating the statistical power and the minimum detectable effect size difference (MDESD) with confidence intervals for investigating the effects of various moderators in three-level MCRTs. We considered the levels of the moderators (level-1, −2, and −3), the scales of the moderators (binary and continuous), and random and nonrandomly varying slopes of the (moderated) treatment effects. We validated our formulas through Monte Carlo simulations. Finally, we conclude with directions for future work.

Locoregional control and toxicity following high-dose hypofractionated and accelerated palliative radiotherapy regimens in breast cancer

AimsFor patients with locally advanced primary/recurrent breast cancer, radiotherapy is an effective treatment for locoregional control. 36 Gy in 6 Gy once-weekly fractions is a commonly used schedule, but there are no data comparing local control and toxicity between 36 Gy delivered once-weekly versus accelerated schedules of multiple 6 Gy fractions per week. This retrospective study compared local control rates and acute and late toxicity in patients undergoing 30–36 Gy in 6 Gy fractions over 6 weeks versus more accelerated schedules over 2–3 weeks for an unresected breast cancer. Materials and methodsPatients who received 30–36 Gy in 6 Gy fractions to an unresected breast cancer ± involved lymph nodes between December 2011 and August 2020 were identified. Patients were grouped into once-weekly versus accelerated fractionation schedules. Response rates, local control and toxicity data were analysed. ResultsIn total, 109 patients were identified. The median follow-up duration was 46 months. Forty-seven patients (43%) received once-weekly fractions and 62 patients (57%) received accelerated fractionation schedules. There were no significant differences in baseline tumour characteristics between the groups. Eighty-seven per cent of patients had an objective (complete or partial) response (81% in the once-weekly group; 91% in the accelerated group). The median time to local progression was 23.5 months overall (95% confidence interval 17.8–29.2); 23.5 months (95% confidence interval 18.8–28.1) in the once-weekly group and 19.0 months (95% confidence interval 7.0–31.1) in the accelerated group (P = 0.99). Acute toxicity of any grade occurred in 75% of patients (76% in the once-weekly group; 74% in the accelerated group) and grade 3 toxicity occurred in 7% of patients (7% in the once-weekly group; 8% in the accelerated group). There were no associations between the groups and acute or late toxicity grade (P = 0.78 and P = 0.26, respectively), although one grade 4 late toxicity (skin radionecrosis) occurred in a patient who received five fractions a week and therefore this regimen is not recommended. Study limitations included a lack of statistical power analysis, the necessary grouping of all accelerated patients for analysis and a high rate of censored data. ConclusionThere were no apparent differences in response rate, time to local progression or toxicity between patients who received 30–36 Gy in 6 Gy fractions once-weekly compared with twice-weekly as palliative treatment for locally advanced breast cancer. This regimen appears to be a safe alternative and may be preferred by patients.

Movedesign: Shiny R app to evaluate sampling design for animal movement studies

Abstract Projects focused on movement behaviour and home range are commonplace, but beyond a focus on choosing appropriate research questions, there are no clear guidelines for such studies. Without these guidelines, designing an animal tracking study to produce reliable estimates of space‐use and movement properties (necessary to answer basic movement ecology questions), is often done in an ad hoc manner. We developed ‘movedesign’, a user‐friendly Shiny application, which can be utilized to investigate the precision of three estimates regularly reported in movement and spatial ecology studies: home range area, speed and distance travelled. Conceptually similar to statistical power analysis, this application enables users to assess the degree of estimate precision that may be achieved with a given sampling design; that is, the choices regarding data resolution (sampling interval) and battery life (sampling duration). Leveraging the ‘ctmm’ R package, we utilize two methods proven to handle many common biases in animal movement datasets: autocorrelated kernel density estimators (AKDEs) and continuous‐time speed and distance (CTSD) estimators. Longer sampling durations are required to reliably estimate home range areas via the detection of a sufficient number of home range crossings. In contrast, speed and distance estimation requires a sampling interval short enough to ensure that a statistically significant signature of the animal's velocity remains in the data. This application addresses key challenges faced by researchers when designing tracking studies, including the trade‐off between long battery life and high resolution of GPS locations collected by the devices, which may result in a compromise between reliably estimating home range or speed and distance. ‘movedesign’ has broad applications for researchers and decision‐makers, supporting them to focus efforts and resources in achieving the optimal sampling design strategy for their research questions, prioritizing the correct deployment decisions for insightful and reliable outputs, while understanding the trade‐off associated with these choices.

Characterization of sleep in emerging adults with cystic fibrosis on elexacaftor/tezacaftor/ivacaftor

Characterization of sleep in emerging adults with cystic fibrosis on elexacaftor/tezacaftor/ivacaftor

Acetabular cup placement and offset control in robotic total hip arthroplasty performed through the modified anterolateral approach.

The modified anterolateral approach (Röttinger) for total hip arthroplasty (THA) offers great advantages over conventional approaches, especially concerning early postoperative symptoms, which are mild and well tolerated by patients. Robotic-assisted implantation might facilitate rapid adoption of the modified anterolateral approach without exposing surgeons to risks encountered during the learning curve. This study posits that the use of robotic assistance in conjunction with the modified anterolateral approach for total hip arthroplasty (THA) can provide a substantial enhancement in the accuracy of cup placement in comparison to manual surgery. Thirty-two robotic-assisted THAs met the inclusion criteria and were matched to 32 conventional cases. Acetabular cup inclination, anteversion, limb-length discrepancy, and acetabular offset were assessed using certified planning software by two independent observers using pre- and postoperative anterior-posterior radiographs. Data was analyzed for normal distribution. Chi2 test was used to determine whether implanted acetabular cups that were within Lewinnek's safe zones were influenced by type of implantation. Effect size estimates and statistical power analysis were also performed to appreciate the appropriateness of the chosen sample size. Robotic-assisted implantation was found to significantly improve acetabular cup placement in terms of inclination (p < 0.001) but not anteversion (p = 0.783). Although mean postoperative limb-length discrepancy and mean acetabular offset did not differ between groups, a significantly smaller variance was found in the robotic-assisted group (p < 0.001) and (p = 0.04), respectively. There were no significant differences between the two groups in terms of consistently implanting the acetabular cup within the Lewinnek safe zones p = 0.641 for anteversion and p = 0.230 for inclination, respectively. Our results show that although robotic-assisted acetabular cup implantation performed through the modified anterolateral approach did not significantly differ from conventional implantation, it did offer increased accuracy in cup positioning, acetabular bone preservation, and limb-length restoration.

Evaluation of acceptance risks and rewards for highway materials using statistical power analysis

ABSTRACT State highway agencies (SHAs) use contractor test results in the acceptance and pay rewards of materials and construction. F- and t- tests are commonly used for validating contractor test results. However, these tests are based on sample statistics, which may lead to significant acceptance risks and inconsistent rewards. In this study a Monte Carlo simulation process was developed to systematically quantify the acceptance risks and assess the implications on pay factors (PF). The simulation was performed using typical acceptance quality characteristics (AQCs), such as thickness, for Portland cement concrete (PCC) pavements. The statistical power of the F- and t-test was determined. The analysis indicated that specific combinations of contractor and agency sample sizes and population characteristics have a greater impact on the acceptance risks and may provide inconsistent PF. Thus, the findings of this study can assist both agencies and producers to better assess the acceptance risks and rewards associated with the validation procedures. Therefore, the proposed methodology can be adopted by SHAs to develop statistically valid verification procedures and thus more rational quality assurance (QA). Producers may use such analysis to identify the level of risks and rewards associated with the current production and identify potential improvements in quality.

D71. Meta-analyses in Plastic Surgery Demonstrate Need for Adequate Assessment of Publication Bias

PURPOSE: Publication bias describes a phenomenon in which significant positive results have higher likelihood to be published compared to negative or non-significant results. Publication bias can confound the estimated therapeutic effect in meta-analyses and needs to be adequately assessed in Plastic Surgery literature. METHODS: A review of meta-analyses published in five Plastic Surgery journals from 2002-2022 was conducted. Inclusion criteria for meta-analyses were factors that demonstrated obligation to assess publication bias, such as interventions with comparable treatment groups and enough power for statistical analysis. Acknowledgment of publication bias risk, quality of bias assessment, methods used in assessment, and individual article factors were analyzed. RESULTS: 318 unique meta-analyses were identified in literature search, and after full-text reviews, 143 met inclusion criteria for obligation to assess publication bias. 64% of eligible meta-analyses acknowledged the confounding potential of publication bias, and only 46% conducted a formal assessment. Of those who conducted an assessment, 49% used subjective inspection of funnel plots alone, while 47% used any statistical testing in analysis. Overall, only 9/143 (6.3%) assessed publication bias and attempted to correct for its effect. Journals with a higher average impact factor were associated with mention and assessment of publication bias, but more recent publication year and higher number of primary articles analyzed were not. CONCLUSION: This review identified low rates of proper publication bias assessment in meta-analyses published in five major Plastic Surgery journals. Assessment of publication bias using objective statistical testing is necessary to ensure integrity of literature within Plastic Surgery.

Size selectivity of a novel non-mesh codend (the Modular Harvesting System) in a New Zealand deepwater fishery

The Modular Harvesting System (MHS) is an inflatable membrane-like fabric tube with escapement holes that replaces the mesh codend of a trawl, and is designed to reduce damage to catch by providing fish a low-flow, low-turbulence environment that allows them to maintain swimming control and avoid compaction during trawling and haulback. The MHS gear is now used within New Zealand’s most valuable finfish fishery, deepwater hoki/blue grenadier (Merlucciidae, Macruronus novaezelandiae). This work presents the novel research used to estimate the size selectivity of the MHS gear, and to compare this to the selectivity of the conventional mesh trawl. Management objectives required estimates of the absolute size-selectivity of both the MHS and conventional gears, and also an estimate of their relative selectivity. An innovative statistical power analysis was developed to specify the required number of twin-trawl tows and number of fish to measure to ensure the desired statistical power to detect a meaningful difference between conventional and MHS gears. A novel twin-trawl experiment was employed whereby the conventional and MHS gears were each paired with a nonselective control, and then the conventional and MHS trawls were paired. All catch data were simultaneously analyzed in a hybrid selectivity model. The MHS and conventional gears had similar estimated size-selectivity curves, and they were not significantly different.

Corporate giving as earnings quality signal: some new evidence from Nigeria

PURPOSE – The purpose of this paper is to re-examine the effect of CSR disclosures on earnings quality in Nigeria beyond the conventional wisdom of statistical significance. DESIGN/METHODOLOGY/APPROACH – The sample consists of 300 company-year observations from 2013 to 2018 of listed companies on the Nigerian Stock Exchange. The research hypothesis was tested using multivariate linear regression on the total sample and subsamples. Pre-study statistical power analysis was carried out to ensure that the study is adequately powered to detect an effect if it exists. FINDINGS – The main results suggest that corporate giving is not related to earnings quality. Though, additional analysis for the income-decreasing subsample was statistically significant, the effect size for both the primary and additional analyses is weak, negligible, and unlikely to be of any practical significance. The results retained their robustness after further analysis. PRACTICAL IMPLICATIONS – The findings could inspire policymakers and regulators to shift attention to other areas of CSR that matters. It could also serve as an input to the current debate on CSR, especially the ongoing consideration of a Bill for an Act to regulate corporate giving in Nigeria. ORIGINALITY/VALUE – This is probably the first papers to provide critical results index needed for substantive comparison of future studies. Hence, the paper serves as a baseline for future research on the topic.

Reverse graphical approaches for multiple test procedures

ABSTRACT The graphical approach has been proposed as a general framework for clinical trial designs involving multiple hypotheses, where decisions are made only based on the observed marginal p -values. The graphical approach starts from a graph that includes all hypotheses as vertices and gradually removes some vertices when their corresponding hypotheses are rejected. In this paper, we propose a reverse graphical approach, which starts from a set of singleton graphs and gradually adds vertices into graphs until rejection of a set of hypotheses is made. Proofs of familywise error rate control are provided. A simulation study is conducted for statistical power analysis, and a case study is included to illustrate how the proposed approach can be applied to clinical studies.

Abstract OT3-33-01: Prospective, Multi-Center, Artificial Intelligence Study for Early Prediction of Serious Events under Treatment Is Now Open for Recruitment in Breast Cancer - OMCAT Trial in Progress

Abstract Background: Aim of the OMCAT trial (‘One Million CAncer Treatment months’, NCT04531995) is improvement of cancer patient care and safety by developing artificial intelligence (AI)-based, incident prediction algorithms. Incident detection allows early notification of treatment teams, enabling timely management changes or interventions. Ultimately the algorithms can also support improved health resource allocation. This trial in progress aims to provide learning databases in breast cancer comprising both electronic patient reported outcome (ePRO) data using the mobile medical device ‘CANKADO PRO-React’ and ground truth outcome data, which provide disease-specific events of interest (“incidents”) verified by the physician (e.g., during patient examinations). Methods: Incident prediction is posed as an application of stochastic time series analysis using AI and knowledge engineering technology. The learning process begins by fitting individualized and disease-specific stochastic process models to “incident-free” intervals extracted from the ePRO data series. Incidents produce detectable deviations from “ordinary” ePRO fluctuations. The algorithms are trained on CANKADO PRO-React data to produce real-time risk functions for predicting incidents on a clinically specified time horizon. Results: Considering the heterogeneity and combinatorics of diseases, stages, therapies, and types of events considered in this study, ultimately the AI algorithms aim to discover about 360 distinct predictive relationships. The estimate of one million treatment months is derived from statistical power analysis of this target, considering estimated median documentation time of six months per patient and estimated 400-500 patients per predictive relationship. To date, 45 centers in Germany have expressed interest in participating. This participation level will enable proof of principle. Ethics votes are already available in most regions. Other centers are invited to participate in this trial. Conclusions: OMCAT opens a whole new path towards evidence-trained AI and a novel combination of patient observation and predictive care. The goals of OMCAT are ambitious and will therefore require many more supporters. Citation Format: Timo Schinköthe, Christian Horst Tonk, Ronald Kates, Sherko Küemmel, Fatima Cardoso, Nadia Harbeck, Peter Staib, Annette Schmidt. Prospective, Multi-Center, Artificial Intelligence Study for Early Prediction of Serious Events under Treatment Is Now Open for Recruitment in Breast Cancer - OMCAT Trial in Progress [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-33-01.