Sample Size Calculation Research Articles

Change-readiness instrument for library managers: development and analysis of a scale

PurposeThis study focuses on developing a scale that encompasses aspects of readiness to change by library management in dealing with the next normal scenario in libraries. It investigates measuring change readiness in terms of library service operations, workflows, administration, programs and spaces, which can give an overview of a library institution's preparedness to meet new roles and expectations.Design/methodology/approachThe descriptive quantitative research was employed using a two-phase approach. It attempts to design an instrument referred to as change-readiness instrument for library managers (CRILM), which was derived from an original self-developed questionnaire consisting of a 20-item readiness-for-change attributes. Validity and reliability of CRILM were tested using Exploratory Factor Analysis and Cronbach’s Alpha. Sample size calculation was employed to determine the required number of subjects to participate in the study. Library managers who are head librarians from different types of libraries were the target samples. Content validation of the items was conducted for suitability and context.FindingsCRILM was tested both valid and reliable. The initial results yielded from the respondent sample indicated that CRILM is deemed suitable for measuring change-readiness among library managers and libraries. The factor-analyzed items were grouped into three subscales based on their characteristics, namely, flexibility in work and services, learning support readiness and adaptive to changing service environments.Research limitations/implicationsCRILM covered the major domains and constructs of change readiness in the context of a library setting. However, the scale should be subjected to further testing and use by a wider target group to strengthen its usability and confidence level. Item analysis was not employed.Practical implicationsThe results of the study offer help to library managers in assessing the readiness of their organizations to effectively manage change and be future-ready.Originality/valueThis study attempts to bridge the gap in readiness-for-change instruments by introducing a scale in the library service environment as a potential contribution in the practice of library management.

A Predictive Noninvasive Single-Nucleotide Variation-Based Biomarker Signature for Resectable Pancreatic Cancer: Protocol for a Prospective Validation Study.

Single-nucleotide variations (SNVs; formerly SNPs) are inherited genetic variants that can be easily determined in routine clinical practice using a simple blood or saliva test. SNVs have potential to serve as noninvasive biomarkers for predicting cancer-specific patient outcomes after resection of pancreatic ductal adenocarcinoma (PDAC). Two recent analyses led to the identification and validation of three SNVs in the CD44 and CHI3L2 genes (rs187115, rs353630, and rs684559), which can be used as predictive biomarkers to help select patients most likely to benefit from pancreatic resection. These variants were associated with an over 2-fold increased risk for tumor-related death in three independent PDAC study cohorts from Europe and the United States, including The Cancer Genome Atlas cohorts (reaching a P value of 1×10-8). However, these analyses were limited by the inherent biases of a retrospective study design, such as selection and publication biases, thereby limiting the clinical use of these promising biomarkers in guiding PDAC therapy. To overcome the limitations of previous retrospectively designed studies and translate the findings into clinical practice, we aim to validate the association of the identified SNVs with survival in a controlled setting using a prospective cohort of patients with PDAC following pancreatic resection. All patients with PDAC who will undergo pancreatic resection at three participating hospitals in Switzerland and fulfill the inclusion criteria will be included in the study consecutively. The SNV genotypes will be determined using standard genotyping techniques from patient blood samples. For each genotyped locus, log-rank and Cox multivariate regression tests will be performed, accounting for the relevant covariates American Joint Committee on Cancer stage and resection status. Clinical follow-up data will be collected for at least 3 years. Sample size calculation resulted in a required sample of 150 patients to sufficiently power the analysis. The follow-up data collection started in August 2019 and the estimated end of data collection will be in May 2027. The study is still recruiting participants and 142 patients have been recruited as of November 2023. The DNA extraction and genotyping of the SNVs will be performed after inclusion of the last patient. Since no SNV genotypes have been determined, no data analysis has been performed to date. The results are expected to be published in 2027. This is the first prospective study of the CD44 and CHI3L2 SNV-based biomarker signature in PDAC. A prospective validation of this signature would enable its clinical use as a noninvasive predictive biomarker of survival after pancreatic resection that is readily available at the time of diagnosis and can assist in guiding PDAC therapy. The results of this study may help to individualize treatment decisions and potentially improve patient outcomes. DERR1-10.2196/54042.

Citizens’ Perception on Effects of Kidnapping on Security in Edo South Senatorial District

The cases of kidnapping in Nigeria and in Edo State in particular are rising, and taking dangerous dimensions. What exists in the literature is an ample of research reports on the causes and socioeconomic implications of kidnapping. The general objective of this study is to explore citizens’ perception of the effects of the rising incidence of kidnapping on the security situations in Edo South Senatorial District of Edo State. The exploratory research design operated with the cross sectional research design was adopted for this study. The calculated sample size for this study was placed at approximately 816. For the collection of qualitative data, the purposive sampling techniques were used to select two interviewees from each of the local government areas. Hence, there were 14 interviewees for the collection of qualitative data that complemented the quantitative data. The majority of respondents (54.7%) believe that the death of victims during kidnappings is avoidable or preventable. There was statistically significant difference in the perception of the level of panic due to kidnapping in Edo South according to the age groups. There is statistically significant association between educational qualification and the tendency to get the Police involved in cases of kidnapping. There was statistically significant difference in perceived police effectiveness in the fight against kidnapping in Edo South according the respondents’ nature of employment. In conclusion, there is a significant number of people who are concerned about kidnapping in their area, with most of affirming a high level of panic due to kidnapping. Kidnapping has a negative impact on society and is a source of fear and concern for many people. The lack of proper security measures adds to the problem, and people are left to take precautions to avoid being kidnapped. The citizens are adjusting to the panic caused by kidnapping by taking practical measures to ensure their safety and seeking solace through spiritual practices. It is recommended that the police should take proactive measures to prevent kidnappings, have the necessary resources and training to handle kidnapping cases, and work with other security agencies and organizations to provide support and services to victims after their release.

An interventional cross-sectional study of electrolyte levels in newborns with hyperbilirubinemia before and after phototherapy in a tertiary care hospital in central India

Introduction This study protocol outlines a comprehensive investigation into the impact of phototherapy on electrolyte levels in newborns with hyperbilirubinemia. With a focus on neonates admitted to the Neonatal Intensive Care Unit (NICU) at Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India, the research aims to contribute valuable insights into the physiological changes associated with this common neonatal condition. The study’s introduction highlights the rationale, significance, and gaps in current knowledge, emphasising the need for a detailed exploration of electrolyte dynamics before and after phototherapy. Method The methodology involves a descriptive, interventional cross-sectional design with a calculated sample size of 264 neonates. Standardised protocols for data collection, including serum electrolyte analysis and urine-specific gravity assessment, will be employed. Inclusion and exclusion criteria are clearly defined to ensure a homogenous study population. Statistical analyses, utilising R Studio 4.3.1 will encompass descriptive statistics, comparative analysis, correlation analysis, and multivariate analysis to explore the nuanced relationships between variables. Rigorous ethical considerations and transparency in reporting will guide the data collection process. Expected Result Anticipated outcomes include a nuanced understanding of changes in serum electrolyte levels following phototherapy and the correlation of these changes with the treatment duration. The study is poised to shed light on the impact of gestational age and birth weight on electrolyte responses. Through rigorous statistical analysis, the research aims to provide evidence-based insights that can inform neonatal care protocols. The anticipated findings hold the potential to influence clinical practices, enhancing the quality of care provided to newborns with hyperbilirubinemia undergoing phototherapy.

A Comparison Between Skeletal Class II and Class III Malocclusion Patients in Terms of the Masticatory Muscles' Activity: A Cross-Sectional Study.

Background This study aimed to determine if individuals with skeletal Class II and skeletal Class III malocclusions had different levels of masticatory muscle activity. Materials and methods This cross-sectional study, conducted at the University of Damascus, investigated the myoelectric activity of perioral muscles in patients with Class II and III malocclusions. The sample size of 60 patients was determined according to a prior sample size calculation. Patients were selected based on specific inclusion and exclusion criteria and divided into Class II and III groups. Electromyography was used to monitor the activity of various muscles, including the temporalis, masseter, orbicularis oris, buccinator, mentalis, and digastric muscles. Results The study found similar muscle activity within the same group in the temporalis, masseter, buccinator, digastric, and orbicularis oris muscles. No significant differences were observed between the Class II and III groups for several oral and perioral muscles (P > 0.05). However, the mean activity of the digastric muscle was significantly greater in the Class II group (P < 0.05), whereas the mean activity of the mentalis muscle was smaller in the Class II group (P < 0.05). Conclusions Perioral muscles influence facial complex development and jaw relationship, affecting orthodontic treatment. Digastric muscle activity is greater in Class II patients, while mental muscle activity is smaller in Class III patients. Further studies are needed for older age groups and other skeletal malocclusion types.

Improved Test Procedure and Sample Size Calculation for Assessing Similarity in Two-Group Comparative Studies with Heterogeneous Variances

AbstractThe two one-sided tests (TOST) method for mean equivalence or average equivalence has been extended to assessing similarity or switchability for individual equivalence in clinical trials. Tolerance interval procedures are available to establish similarity with respect to the proportion of the response differences covered by a prespecified threshold range. However, the extended TOST procedures based on tolerance intervals are potentially susceptible to the control of Type I errors. This article aims to present an exact approach with the specified Type I error probability for appraising similarity between two treatments in comparative studies with heterogeneous variances. Analytic examination and numerical comparison are conducted to clarify the utility of the suggested similarity test and the drawback of the current TOST procedures. To enhance the usefulness of the described exact method, the related power and sample size issues are also considered. Computer algorithms are provided to implement the proposed test procedure, power calculation, and sample size determination in similarity studies.

Prevalence of Noncommunicable Disease (NCDs) risk factors in Tamil Nadu: Tamil Nadu STEPS Survey (TN STEPS), 2020.

Noncommunicable diseases (NCDs) account for nearly 75% of all deaths in Tamil Nadu. The government of Tamil Nadu has initiated several strategies to control NCDs under the Tamil Nadu Health Systems Reform Program (TNHSRP). We aimed to estimate the prevalence of NCD risk factors and determine the predictors of diabetes and hypertension, which will be helpful for planning and serve as a baseline for evaluating the impact of interventions. A state-wide representative cross-sectional study was conducted among 18-69-year-old adults in Tamil Nadu in 2020. The study used a multi-stage sampling method to select the calculated sample size of 5780. We adapted the study tools based on WHO's STEPS surveillance methodology. We collected information about sociodemographic factors, NCD risk factors and measured blood pressure and fasting capillary blood glucose. The predictors of diabetes and hypertension were calculated using generalised linear models with 95% confidence intervals (95% CI). Due to the COVID-19 pandemic lockdown, we could cover 68% (n = 3800) of the intended sample size. Among the eligible individuals surveyed (n = 4128), we had a response rate of 92%. The mean age of the study participants was 42.8 years, and 51% were women. Current tobacco use was prevalent in 40% (95% CI: 33.7-40.0) of men and 7.9% (95% CI: 6.4-9.8) of women. Current consumption of alcohol was prevalent among 39.1% (95% CI: 36.4-42.0) of men. Nearly 28.5% (95% CI: 26.7-30.4) of the study participants were overweight, and 11.4% (95% CI: 10.1-12.7) were obese. The prevalence of hypertension was 33.9% (95% CI: 32.0-35.8), and that of diabetes was 17.6% (95% CI: 16.1-19.2). Older age, men, and obesity were independently associated with diabetes and hypertension. The burden of NCD risk factors like tobacco use, and alcohol use were high among men in the state of Tamil Nadu. The prevalence of other risk factors like physical inactivity, raised blood pressure and raised blood glucose were also high in the state. The state should further emphasise measures that reduce the burden of NCD risk factors. Policy-based and health system-based interventions to control NCDs must be a high priority for the state.

Exploring Sample Size Determination in Educational Research: A Comprehensive Review

Background By conducting an in-depth study of the publications, a review was conducted with the goal of evaluating the sample size in educational research. The sample size, represented by the letter “n,” is a key factor in this research because it specifies the number of participants who represent the target population. Although various studies have been published in the literature defining the processes for calculating sample sizes, there is still much uncertainty. It is vital to understand that there is no single all-encompassing method for determining sample sizes for different study designs. Instead, different study designs call for different approaches to determine sample numbers. Methods Information was retrieved from the databases in accordance with updated PRISMA recommendations. The keywords used for the retrieval of the relevant articles from two databases (Google Scholar and PubMed). The articles were selected by thorough scrutiny and application of inclusion and exclusion criteria. Results Seven articles were selected and the comparison was made among the studies in the relation to methods, objective, and outcome from the enrolled studies. Conclusions The evaluation of the seven studies as a whole concluded that the sample size for testing any novel approach essentially required 24.24 participants in each group. The median sample size for the simulation-based educational research was 30. Further research is required to determine the proper sample size based on a single universal formula for all types of designs.

Adaptive two-stage seamless sequential design for clinical trials

ABSTRACT We propose an adaptive sequential testing procedure for the selection and testing of multiple treatment options, such as dose/regimen, different drugs, sub-populations, endpoints, or a mixture of them in a seamlessly combined phase II/III trial. The selection is to be made at the end of phase 2 stage. Unlike in many of the published literature, the selection rule is not required to be to “select the best”, and does not need to be pre-specified, which provides flexibility and allows the trial investigators to use any efficacy and safety information/criteria, or surrogate or intermediate endpoint to make the selection. Sample size and power calculations are provided. The calculations have been confirmed to be accurate by simulations. Interim analysis can be performed after the selection, sample size can be modified if the observed efficacy deviates from the assumed. Inference after the trial, including p-value, median unbiased point estimate and confidence intervals, are provided. By applying a dominance theorem, the procedure can be applied to normal, binary, Poisson, negative binomial distributed endpoints and time-to-event endpoints, and a mixture of these distributions (in trials involving endpoint selection).

Levels of anti-topoisomerase I antibody correlated with short onset of cardiopulmonary involvement in Thai systemic sclerosis patients

Anti-topoisomerase-I antibody (ATA) is associated with disease severity and internal organ involvement in patients with systemic sclerosis (SSc). The correlation between ATA levels and the clinical course of SSc is unclear. We aimed to determine the correlation between ATA level and survival time and the onset of internal organ fibrosis in SSc patients. This historical cohort study was conducted in adult SSc patients with quantitative tests of ATA between January 2019 and December 2022. Patients with overlap syndrome and no quantitative ATA test were excluded. According to the sample size calculation, and 10% compensated for missing data, a total of 153 patients were needed. The respective mean age on the study date and median ATA level was 59.9 ± 11.3 years and 370 U/mL (range 195–652). Most cases (107 cases; 69.9%) were the diffuse cutaneous SSc subset. According to a multivariable analysis, the ATA titer had a negative correlation with the onset of cardiac involvement (Rho − 0.47, p = 0.01), and had a positive correlation with skin thickness progression (Rho 0.39, p = 0.04). Eleven cases exhibited ATA levels < 7 U/mL and outlier ATA levels were excluded, 142 cases were included in the sensitivity analysis, and multivariable analysis showed the correlation between early onset of ILD and cardiac involvement (Rho − 0.43, p = 0.03 and Rho − 0.51, p = 0.01, respectively). The ATA level was correlated with neither the survival time nor the onset of renal crisis in both analyses. High ATA levels were correlated with a short onset of ILD and cardiac involvement and the presence of extensive skin tightness. Quantitative tests of ATA could serve as an effective tool for identifying patients at risk of an unfavorable prognosis.

RETRACTION: A randomized trial of local endometrial injury during ovulation induction cycles.

Helmy, M. E. E., Maher, M. A., Elkouly, N. I., Ramzy, M. (2017) A randomized trial of local endometrial injury during ovulation induction cycles. International Journal of Gynecology & Obstetrics, 138: 47-52. https://doi.org/10.1002/ijgo.12178. The above article, published online on 11 April 2017 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor-in-Chief, Professor Michael Geary, the International Federation of Gynecology and Obstetrics, and John Wiley and Sons Ltd. Concerns were raised by a third party about inconsistencies in the data of this article and the authors were asked to provide an explanation. The authors responded to the journal's inquiry, but could not share original data. Following the authors response, an independent review concluded that the sample size calculations were not reproducible, that the analysis of live births was misreported, and that, due to the absence of original data, the journal was not able to reproduce the calculations for relative risks reported in the manuscript. The journal has determined that these errors fundamentally compromise the conclusions of the article and that they could not be addressed by a correction. As such, the journal is issuing this retraction. The authors disagree with this retraction.

Schreiben eines Forschungsantrags

AbstractThe key to success in securing financial support for research projects lies in the preparation of a well-crafted research grant proposal, showcasing the competence, dedication, and organizational skills of the research group as well as the scientific merit of the proposed study. This paper delineates the essential elements of a successful funding proposal, providing a structured guide to enhance the prospects of obtaining the necessary financial support. In general, the research project should align with the objectives and priorities of the funding agency. Attention to formalities, such as proper formatting and adherence to application guidelines, is mandatory. The core component of a research grant proposal is the formulation of a clear and well-founded research question and hypothesis. The methodology section should address the measurement methods and experimental setup. Additionally, developing a realistic research schedule and milestones is of great importance, along with anticipating potential barriers and challenges. Finally, the proposal’s financial aspect is addressed through a detailed cost breakdown that aligns with the sample size calculation and methodology.

Screening for Hypertension in adolescents living with HIV: Protocol for a cluster randomized trial to improve guideline adherence.

Although AIDS-related deaths have reduced with increased access to antiretroviral care, cardiovascular disease-related morbidities among persons living with HIV are rising. Contributing to this is the higher incidence of Hypertension among Persons Living with HIV. The duration of exposure to the virus and antiretroviral drugs plays a vital role in the pathogenesis, putting perinatally infected children and adolescents at higher risk than behaviorally-infected ones, supporting the calls for increased surveillance of Hypertension among them. Despite the availability of guidelines to support this surveillance, the blood pressure (BP) of adolescents living with HIV (ADLHIV) is not checked during clinical visits. This study aims to assess the effect of a theory-based intervention on healthcare workers' adherence to the guidelines for hypertension screening among adolescents. A multi-facility cluster-randomized study will be conducted. The clusters will be 20 antiretroviral therapy sites in the Greater Accra Region of Ghana with the highest adolescent caseload. Data will be extracted from the folders of adolescents (10-17 years) who received care in these facilities six months before the study. The ART staff of intervention facilities will receive a multicomponent theory of planned behaviour-based intervention. This will include orientation on hypertension risk among ADLHIV, provision of job aids and pediatric sphygmomanometers. Six months after the intervention, the outcome measure will be the change from baseline in the proportion of ADLHIV whose BP was checked during clinical visits. The calculated sample size is 400 folders. This study will generate evidence on the effectiveness of a multicomponent theory-based intervention for improving the implementation of clinical practice guidelines. PACTR202205641023383.

ACETABULAR FRACTURES IN OLDER PATIENTS INTERVENTION TRIAL (ACEFIT): A FEASIBILITY TRIPLE-ARM RANDOMIZED CONTROLLED STUDY

Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients.This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures.Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8.This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options.

Abstract PO5-19-02: I-PREPARE: International Prospective REgistry on Pre-pectorAl breast Reconstruction (EUBREAST 11R-NCT 05817175)

Abstract Background: Despite the progressive de-escalation of breast cancer (BC) surgery, mastectomy rates remain around 30-40%. Furthermore, up to 1/3 of BC patients undergo a contralateral risk-reducing mastectomy and around 40% of mutation carriers choose a bilateral intervention. To date, immediate breast reconstruction (IBR) with implants is the most commonly performed reconstructive procedure. After an initial experience with implants in subcutaneous positioning under the mastectomy flap in the seventies, this technique was abandoned due to a high rate of implant loss (28%), flap necrosis (13.5%) and capsular contracture (56%). For this reason, the positioning of the implant under the pectoralis major has become the standard of care. However, over time surgical techniques and implants have improved, resulting in decreasing implant loss, flap necrosis and capsular contracture rates. Moreover, biological/synthetic meshes have been used to cover the implant placed over the pectoralis major, thus avoiding to mobilize the muscle with some benefits in terms of reduced complications (no animation deformity, no chronic pain, no loss of muscular function), patients’ wellbeing, postoperative pain and recovery. Additionally, recent literature reported encouraging results with polyurethane breast implants in pre-pectoral positioning without any kind of implant coverage. Although these procedures are considered safe they were not evaluated in prospective randomized trials. In 2019 a joint consensus on pre-pectoral breast reconstruction (PBR) clearly recommended to properly audit the results in terms of surgical complications and patient-reported outcomes. Based on these premises the EUBREAST (European Breast Cancer Research Association of Surgical Trialists, www.eubreast.org) study group decided to launch a prospective international cohort study aimed at comparatively evaluating data on different surgical techniques of PBR with or without PMRT. Therefore, we will prospectively evaluate the utilization of PBR, including surgical, oncological, aesthetic and patients’ satisfaction and quality of life outcomes related to each type of surgical technique and the interaction with post-mastectomy radiation therapy (PMRT). Eligibility criteria: - Female patients age≥18 years - Signed informed consent - Patients undergoing mono/bilateral therapeutic mastectomy and immediate PBR Exclusion criteria - Patients not suitable for surgical treatment - Patients undergoing subpectoral reconstruction, reconstruction with tissue expander or autologous IBR Specific aims: The primary endpoint is implant-loss at 3 months defined as the unplanned removal or loss of the implant, as a result of infection or any other complication Secondary endpoints are infection, re-admission and re-operation rates, quality of life evaluated through BREASTQ Breast Reconstruction Module and EQ-5D-5L questionnaires on an App for patients before and after breast reconstruction at 6, 12, 24 months, early onset complication at 3 months, late-onset complications at 6, 12, 24 months, further surgery at 24 months, time to adjuvant therapy. Tertiary endpoints are further surgery, loco-regional recurrence, disease free survival, breast cancer specific survival, distant-disease free survival, overall survival, development of seroma/breast implant-associated anaplastic cell lymphoma. Statistics: We will use a single-arm design to assess the surgical safety of PBR through implant loss rate at 3 months which is expected to be ≤9% based on previous literature; 12% or greater will be regarded as unacceptably high. The assessment will be based on 1,112 patients. For this sample size calculation, power was set to 90%, and the two-sided alpha was set to 0.05. Allowing for a 10% loss to follow-up at 3 months, we aim at recruiting 1,236 patients. Accrual has not started yet. Funding: EUBREAST ETS Italy Contact: Oreste Davide Gentilini: gentilini@eubreast.org Citation Format: Rosa Di Micco, Maggie Banys-Paluchowski, Maria-Joao Cardoso, Jana de Boniface, Bahadir M. Gulluoglu, Orit Kaidar-Person, Thorsten Kühn, Maurizio Bruno Nava, Philip Poortmans, Shelley Potter, Nicole Rotmensz, Tanja Spanic, Marc Thill, Luzia Travado, Walter Weber, Oreste Davide Gentilini. I-PREPARE: International Prospective REgistry on Pre-pectorAl breast Reconstruction (EUBREAST 11R-NCT 05817175) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-19-02.

Abstract GS02-06: Recurrence-free survival following sentinel node-positive breast cancer without completion axillary lymph node dissection – first results from the international randomized SENOMAC trial

Abstract Background The omission of a completion axillary lymph node dissection (cALND) after a positive sentinel lymph node (SLN) biopsy in patients with clinically node-negative breast cancer has been demonstrated to yield survival outcomes non-inferior to routine cALND in breast-conserving surgery followed by whole-breast irradiation (ACOSOG Z0011 and IBCSG 23-01 trials), and to axillary radiotherapy (RT) regardless of breast surgery (EORTC AMAROS trial). Mainly due to the under-representation of mastectomy patients, and a limited number of observed events compromising statistical power, the international randomized SENOMAC trial was initiated in 2015. The main aim of this non-inferiority trial was to address knowledge gaps relating to individuals treated by mastectomy, those with larger tumors and those with SLN extracapsular extension. Method The SENOMAC trial (NCT 02240472) enrolled patients with cT1-3cN0 primary breast cancer and 1-2 SLN macrometastases at 67 sites in five countries between January 27, 2015, and December 31, 2021. Participants were randomized 1:1 between cALND (standard) and omission of cALND (intervention). Stratification was per country. Breast-conserving surgery and mastectomy were eligible surgical interventions. Preoperative axillary ultrasound was mandatory; patients with non-palpable suspicious axillary lymph nodes, even if proven metastatic by biopsy, were eligible. SLN extracapsular extension was allowed. Adjuvant radiotherapy was dictated by national guidelines and not by the trial protocol. Statistical sample size calculation was based on the primary outcome overall survival. Non-inferiority was defined as a 5-year overall survival not worsened by more than 2.5% when refraining from cALND after the observation of 190 all-cause deaths in a target sample size of 3000 included patients. In the present analysis, the pre-specified secondary outcome of recurrence-free survival is reported. Results Out of 2766 randomized individuals, 2539 comprised the per-protocol population: 1204 in the standard and 1335 in the intervention group. Median follow-up was 37.1 months (1.5-75.0) and median age at inclusion 61 years (range 20-94). Most tumors belonged to the luminal subtype (93.6%); tumor stage was T1 in 1358 (53.5%), T2 in 1034 (40.7%) and T3 in 146 participants (5.8%). Out of 347 participants with suspicious lymph nodes on ultrasound, 36 had confirmed non-palpable metastasis. SLN extracapsular extension was reported in 866 (34.1%). The breast was conserved in 1621 (63.8%) and a mastectomy performed in 918 (36.2%) patients. Most patients (2127, 83.8%) received radiotherapy including nodal target volumes. In 34.1% of the standard group, additional non-SLN metastases were identified on cALND. Overall, 104 recurrences were reported, 54 (4.5%) in the standard and 50 (3.7%) in the intervention group. Of these, 11 recurrences were found in the ipsilateral axilla: 5 (0.4%) and 6 (0.5%), respectively. Recurrence-free survival did not differ between groups (country-adjusted HR 0.89, 95% CI 0.65-1.20). Conclusion Despite extended inclusion criteria, there was no difference in recurrence-free survival whether cALND was omitted (intervention) or not (standard). Patients undergoing mastectomy will specifically be addressed in subgroup analyses. Long-term follow-up is crucial considering the high proportion of luminal cancers. Citation Format: Jana de Boniface, Tove Tvedskov, Bergkvist Leif, Jan Frisell, Yvette Andersson, Sara Alkner, Malin Sund, Roger Olofsson Bagge, Dan Lundstedt, Oreste Davide Gentilini, Michalis Kontos, Toralf Reimer, Birgitte Offersen, Thorsten Kühn, Lisa Rydén, Peer Christiansen. Recurrence-free survival following sentinel node-positive breast cancer without completion axillary lymph node dissection – first results from the international randomized SENOMAC trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-06.

Peran Lingkungan Keluarga, Motivasi, dan Pengetahuan Kewirausahaan terhadap Minat Berwirausaha Mahasiswa

This study aims to investigate the effect of family environment, entrepreneurial motivation, and entrepreneurial knowledge on the entrepreneurial interest of students of the Faculty of Economics and Business (FEB) of XXX University in Padang City. The population used in this study were active students of FEB of XXX University in Padang City in the 2020 and 2021 academic years, totaling 384 people. The non-probability sampling technique was used for sample selection, and sampling was carried out using the Rao soft Sample Size Calculator Software Technique so that a sample of 102 respondents was obtained. The results of research and data analysis show that entrepreneurial motivation is the most influential variable on entrepreneurial interest, with a beta value of 0.496. This indicates that students who have high entrepreneurial motivation tend to have greater entrepreneurial interest. However, family environment and entrepreneurial knowledge also have a significant influence on student entrepreneurial interest, although not as strong as entrepreneurial motivation.

Sample size and power calculation for testing treatment effect heterogeneity in cluster randomized crossover designs.

The cluster randomized crossover design has been proposed to improve efficiency over the traditional parallel-arm cluster randomized design. While statistical methods have been developed for designing cluster randomized crossover trials, they have exclusively focused on testing the overall average treatment effect, with little attention to differential treatment effects across subpopulations. Recently, interest has grown in understanding whether treatment effects may vary across pre-specified patient subpopulations, such as those defined by demographic or clinical characteristics. In this article, we consider the two-treatment two-period cluster randomized crossover design under either a cross-sectional or closed-cohort sampling scheme, where it is of interest to detect the heterogeneity of treatment effect via an interaction test. Assuming a patterned correlation structure for both the covariate and the outcome, we derive new sample size formulas for testing the heterogeneity of treatment effect with continuous outcomes based on linear mixed models. Our formulas also address unequal cluster sizes and therefore allow us to analytically assess the impact of unequal cluster sizes on the power of the interaction test in cluster randomized crossover designs. We conduct simulations to confirm the accuracy of the proposed methods, and illustrate their application in two real cluster randomized crossover trials.

Strength and conditioning in dance: A systematic review and meta‐analysis

Strength and conditioning in dance: A systematic review and meta‐analysis

Immunohistochemical (IHC) Expression of p16 in Various Grades of Oral Squamous Cell Carcinoma (OSCC) with Snuff Use in Tertiary Care Hospitals of Peshawar

Oral squamous cell carcinoma (OSCC) is a significant health concern, with various factors influencing its development and progression. Understanding these factors, including p16 expression and clinicopathologic features, is crucial for improved diagnosis and treatment. Objective: To compare various grades of OSCC based on immunohistochemical expression of p16 and clinicopathologic parameters. Methods: The comparative cross-sectional study was conducted at the Department of Pathology, Peshawar Medical College (PMC), and Peshawar Dental College (PDC) from August 2020 to August 2021. It included 53 cases of OSCC with documented snuff use history. Tumor sections were stained with Hematoxylin and Eosin and underwent immunohistochemical staining for p16 expression. Sample size calculation utilized G Power software. Statistical analysis was performed using SPSS version 20.0, employing the Chi-Square test to assess categorical variables. Results: Among the 53 OSCC cases, the majority were male (66.0%) with ages ranging from 26 to 85 years, the most common age group being 51-70 years. The tongue was the primary site for OSCC development. Well-differentiated cases were predominant (64.2%), followed by moderate (20.8%) and poor grade cases (15.1%). However, no significant association was found between p16 expression and OSCC grades. Notably, p16 expression tended to be higher in snuff users and well-differentiated OSCC cases, although not statistically significant. Conclusions: Well-differentiated OSCC cases exhibited the highest expression of p16, followed by moderate and poorly differentiated cases. However, no significant correlation was observed between p16 expression and OSCC in snuff users.