Categorical Data Research Articles

The protocol for a cluster randomized controlled trial to evaluate couple-based violence prevention education and its ability to reduce intimate partner violence during pregnancy in Southwest Ethiopia.

A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy, which has adverse maternal and newborn outcomes. Couple-focused interventions are effective in reducing and/or controlling violence between women and their intimate partners. However, interventions addressing intimate partners of the victims are not well studied, particularly in the Ethiopian setting. This study aims to assess the effect of couple-based violence prevention education on intimate partner violence during pregnancy. We will use a cluster randomized controlled trial to evaluate the effectiveness of couple-based violence prevention education compared to routine care in reducing intimate partner violence during pregnancy. Sixteen kebeles will be randomly assigned to 8 interventions and 8 control groups. In the trial, 432 couples whose wife is pregnant will participate. Health extension workers (HEWs) will provide health education. Data will be collected at baseline and endline. All the collected data will be analyzed using Stata version 16.0 or SPSS version 25.0. We will use the McNemar test to assess the differences in outcomes of interest in both intervention and control groups before and after the intervention for categorical data. A paired t-test will be used to compare continuous outcome of interest in the intervention and the control groups after and before the intervention. The GEE (Generalized Estimating Equation), will be used to test the independent effect of the intervention on the outcome of the interest. Data analysis will be performed with an intention-to-treat analysis approach. During the analysis, the effect size, confidence interval, and p-value will be calculated. All tests will be two-sided, and statistical significance will be declared at p < 0.05. We expect that the study will generate findings that can illuminate violence prevention strategies and practices in Ethiopia. It has been registered on ClinicalTrials.gov as NCT05856214 on May 4, 2023.

The effect of intraoperative low-dose ketamine versus dexmedetomidine infusion on postoperative bowel recovery in patients undergoing gastrointestinal malignancy surgeries: Placebo-controlled, randomized trial

Abstract Background and Aims: No studies have compared the effects of ketamine and dexmedetomidine on bowel recovery. We evaluated the effects of intraoperative low-dose ketamine or dexmedetomidine infusion on postoperative bowel recovery in patients undergoing gastrointestinal (GI) malignancy surgeries. Material and Methods: This placebo-controlled, randomized study was carried out in 84 American Society of Anesthesiologists II patients, aged 18–70 years, of either gender, undergoing elective open GI malignancy surgeries. Patients received intraoperative infusion of ketamine @ 0.1 mg kg-1 h-1 (KET), dexmedetomidine @ 0.25 μg kg-1 h-1 (DEX), or normal saline (placebo). Primary outcome was the time to first flatus and/or stool. Secondary outcomes included time to extubation, total analgesic requirement, postoperative pain scores, time to feeds, duration of intensive care unit (ICU) and hospital stay, and the incidence of adverse events. Continuous data were analyzed by the one-way analysis of variance (ANOVA) or the Kruskal–Wallis test. Categorical data were analyzed by the Chi-square test or the Fisher’s exact test. Results: Median time to passage of flatus and/or stool was 3 [interquartile range (IQR) 2–3] days in the KET group, 2 [IQR 2–3] days in the DEX group, and 2 [IQR 2–3] days in the placebo group (P = 0.53 for placebo vs. KET, 0.81 for placebo vs. DEX, and 0.99 for KET vs. DEX). Pain scores and analgesic consumption were significantly less in the intervention groups versus placebo (P &lt; 0.001). No difference was seen in other secondary outcomes. Conclusion: Low-dose ketamine or dexmedetomidine did not result in early bowel recovery despite lower pain scores and opioid consumption in patients undergoing open GI malignancy surgeries. Key Message: What is known: Ketamine and dexmedetomidine may promote bowel recovery by improving analgesia and decreasing opioid usage.Main findings: This randomized controlled trial found no evidence of earlier bowel recovery with ketamine or dexmedetomidine versus placebo despite lower pain scores and analgesic consumption in the ketamine and dexmedetomidine groups.

Ethiopian Early Grade English Teachers’ Preparedness to Teach Basic Reading Skills

Ethiopian children in early grades were found to be significantly nonreaders after 2–3 years of schooling regardless of linguistic variation. This is mainly attributed to the way children are taught basic literacy skills, which is attributed to teacher preparation and training. This research aimed to examine Ethiopian early grade teachers’ preparedness to teach basic reading skills. Five schools were randomly selected out of 44 public primary schools in the research site. Among 40 teachers of English in the selected schools, 32 teachers were willing to take knowledge assessment test and fill in the questionnaire. Two of knowledge test papers and two pieces of questionnaire were rejected because the responses were incomplete. The data were gathered from (n = 30) randomly selected primary schools English teachers by using a questionnaire and knowledge assessment test. Data analysis was done using Statistical Package for Social Sciences (SPSS Version 25.0). Descriptive statistics were calculated for the responses to knowledge test and questionnaire. Pearson’s correlation was calculated for the relationship among teacher preparation coursework emphasis, practicum attention, and teachers’ felt preparedness to teach basic reading after categorical data were transformed into scale. The results have shown that primary school English teacher preparation designated only certain lecture sessions of coursework and few of activities of practicum to teaching early reading. The average knowledge assessment test score of teachers was 43.4%; 21 (70%) of the teachers achieved below 50% while 9 (30%) of them achieved 50% and above. There is a statistically significant relationship among teacher preparation coursework emphasis, practicum attention, and teachers’ felt preparedness to help Ethiopian children learn to read. It can be concluded from the results that teacher preparation both in its courses and practicum activities did not place due emphasis on teaching teachers to teach basic reading skills. Participant English teachers also had knowledge gap about early reading instruction. Thus, participant English teachers were not adequately prepared to teach early grade reading. Teacher preparation coursework emphasis, practicum attention, and teachers’ felt preparedness to teach early grade reading have a strong positive relationship.

Categorical Data Clustering: A Bibliometric Analysis and Taxonomy

Numerous real-world applications apply categorical data clustering to find hidden patterns in the data. The K-modes-based algorithm is a popular algorithm for solving common issues in categorical data, from outlier and noise sensitivity to local optima, utilizing metaheuristic methods. Many studies have focused on increasing clustering performance, with new methods now outperforming the traditional K-modes algorithm. It is important to investigate this evolution to help scholars understand how the existing algorithms overcome the common issues of categorical data. Using a research-area-based bibliometric analysis, this study retrieved articles from the Web of Science (WoS) Core Collection published between 2014 and 2023. This study presents a deep analysis of 64 articles to develop a new taxonomy of categorical data clustering algorithms. This study also discusses the potential challenges and opportunities in possible alternative solutions to categorical data clustering.

TIMING OF THE STOMA REVERSAL, WHAT IS THE SAFE PERIOD?: A RETROSPECTIVE OBSERVATIONAL STUDY

Objective: The objective of the study is to determine the most suitable timing for the reversal of enteric stomas and to investigate the complications associated with the presence and reversal of stomas among different age groups and genders. Methods: This was a retrospective study conducted in the Department of General Surgery of a tertiary care medical institute. The institutional ethical committee approved the study. We reviewed the digitally recorded data of patients who had undergone both the creation and reversal of stomas at our institution over various time intervals spanning from January 2017 to December 2022. Beyond the electronically stored clinical data encompassing patient demographics, stoma type, and complications encountered between stoma insertion and reversal, we conducted a thorough review of the database containing information on outpatient follow-ups for a month. The gender and age distribution, indications for surgery, type of stoma, and its correlation with age and gender were analyzed. Duration from surgery to stoma reversal and complications were also analyzed. Categorical data were presented as frequency and percentage, whereas quantitative data were summarized using the mean and standard deviation. Closure of the stoma after surgery was compared based on age and sex, employing an independent t-test. Results: In this study 82 patients undergoing stoma surgery, 68.29% were male and 31.71% were female. The mean age of male and female patients was found to be 44.26 and 35.96 years, respectively. Males had a higher median duration for ileostomy and jejunostomy reversals at 14 and 17 weeks, respectively, whereas females showed longer durations for ileostomy at 15 weeks. Common indications for surgery included intestinal obstruction (32.9%) and peritonitis (20.7%). Post-stoma closure 50% of the patients experienced complications, with 24% occurring within 1 month of reversal. Major complications occurred in 41% of cases, including parastomal hernia and suspected anastomotic leaks. Minor complications were observed in 28 patients, representing 35% of all surgeries. Conclusion: Stoma reversal between 8 and 12 weeks post-surgery is recommended for minimizing complications and avoiding psychological burden. While early closure may reduce hospital stay, it increases the risk of infections. Optimal timing for stoma closure is complex, requiring personalized, collaborative decision-making.

Carotid Body Tumor Excision with and without Carotid Artery Reconstruction: Equivalency of 30-Day Outcomes over 12 Years in the American College of Surgery National Surgical Quality Improvement Program (ACS-NSQIP) Database

Background: Carotid body tumors (CBTs) are rare benign tumors that arise from the chemoreceptor tissue located at the carotid bifurcation that require excision if symptomatic. Depending on the size and location of the tumor, the carotid artery may need to be repaired after resection. This study aims to assess whether CBT excision with artery resection had higher rates of 30-day postoperative outcomes compared with CBT excision without artery resection. Methods: This is a retrospective cohort study. Patients were identified in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) registry from 2005 to 2017. They were divided into two groups, based on Current Procedural Terminology (CPT®) codes: group A had CBT excision without carotid artery excision (CPT code 60600) and group B with carotid artery excision (CPT code 60605). Patient demographic characteristics, co-morbidities, and 30-days postoperative outcomes were compared between the two groups. Categorical data were analyzed using Pearson’s X2 or Fisher exact tests and presented as proportions (percentages). Continuous data were analyzed using parametric or non-parametric tests as appropriate. Statistical significance was defined as p &lt; 0.05. Statistical analysis was performed using the SPSS statistical software package. Results: A total of 463 patients were identified, 410 (88.4%) in group A and 53 (11.4%) in group B. Overall, there were 291 (62.9%) women. A higher proportion of women underwent CBT excision only, compared to men (91.1% [265/291] vs. 84.3% [145/172], p &lt; 0.0001). Demographics and comorbidities were similar between groups. There was no significant difference in the 30-day postoperative outcomes. The reoperation rate was higher in group B (3.8% vs. 1.5%, p = 0.334), while the readmission rate was higher in group A (3.2% vs. 0% p = 0.269), and both were not significantly different. Overall morbidity and serious morbidity were higher in group B (7.5% vs. 5.9%, p = 0.626) and lower in group A (5.7% vs. 3.9%, p = 0.544), respectively, but were not significantly different. Operative time (mean, SD) was higher in group B (187 ± 107 vs. 138 ± 66 min, p &lt; 0.001). However, the median (IQR) of hospital length of stay (LOS) was similar (2 [1, 4] vs. 2 [1, 3] days, p = 0.134). Conclusions: Overall, no difference was noted in the 30-day postoperative outcome between the two surgical approaches of CBT. However, operative time was longer when artery resection was performed. Further research to determine the factors predicting the need for carotid artery resection among patient gender is needed.

Transgender people in clinical trials of drugs and biologics: An analysis of ClinicalTrials.gov from 2007 to 2023.

Transgender people have unmet health needs related to chronic conditions such as dementia, osteoporosis and hypertension. Community-driven advocacy increased transgender representation in phase III trials for pharmacological prevention of HIV, but the extent to which drug trials for other conditions have included transgender people is unknown. We investigated the extent to which trials of drugs and biologics represented transgender people across therapeutic areas on ClinicalTrials.gov. Cross-sectional analysis of trials of drugs and biologics registered on ClinicalTrials.gov from 2007-2023. We included efficacy and effectiveness trials (phase II-IV) with transgender-related terms (e.g. 'transgend*'). We labelled trials as Inclusive or Exclusive of transgender people using the trial eligibility criteria. We compared trials (therapeutic area, trial design, enrolment), summarized trials registered from 2008 onward and characterized participant enrolment for Inclusive trials with primary trial publications. We summarized continuous data using median (range), categorical data using frequencies and percentages and compared trial characteristics using Fisher's exact test. Ninety-seven trials represented transgender people. Characteristics were similar between 85 Inclusive and 12 Exclusive trials. Among Inclusive trials, 58% focused on infectious diseases (e.g. treatment or prevention of HIV and COVID-19), 15% on mental health (e.g. post-traumatic stress disorder, substance use-related disorders), and the remainder focused on endocrine (9%), pain (5%), digestive system disorders (1%) and neoplasms (1%). Twenty (of 25) trials reported enrolment of transgender participants in primary trial publications or reported results. Transgender-inclusive trials have increased since 2008. Most trials focused on infectious diseases and mental health. Investigators should increase opportunities to include of transgender people in trials of drugs and biologics for chronic diseases.

A hypothesis test for detecting spatial patterns in categorical areal data

The vast growth of spatial datasets in recent decades has fueled the development of many statistical methods for detecting spatial patterns. Two of the most commonly studied spatial patterns are clustering, loosely defined as datapoints with similar attributes existing close together, and dispersion, loosely defined as the semi-regular placement of datapoints with similar attributes. In this work, we develop a hypothesis test to detect spatial clustering or dispersion at specific distances in categorical areal data. Such data consists of a set of spatial regions whose boundaries are fixed and known (e.g., counties) associated with a categorical random variable (e.g. whether the county is rural, micropolitan, or metropolitan). We propose a method to extend the positive area proportion function (developed for detecting spatial clustering in binary areal data) to the categorical case. This proposal, referred to as the categorical positive areal proportion function test, can detect various spatial patterns, including homogeneous clusters, heterogeneous clusters, and dispersion. Our approach is the first method capable of distinguishing between different types of clustering in categorical areal data. After validating our method using an extensive simulation study, we use the categorical positive area proportion function test to detect spatial patterns in Boulder County, Colorado USA biological, agricultural, built and open conservation easements.

173 Assessing the impact of fiber and antioxidant supplementation during the periparturient period on gilt constipation, piglet viability, and body condition score

Abstract Fiber supplementation during the periparturient and lactation period is increasingly recognized for its potential to improve sow and litter performance. Yucca saponins and vitamin C have been shown to improve antioxidant status, reduce hypoxia and increase farrowing performance, but their interaction with fiber remains uncharted. The experimental objective was to evaluate fiber supplementation and its combination with yucca and vitamin C during the periparturient period of gilts on constipation status, body condition score, and farrowing performance. A total of 567 gilts were allotted to a randomized complete block design distributed across six farrowing rooms to 1 of 3 dietary treatments (n = 189/treatment). A subset of gilts from one farrowing room (n = 32/treatment) were selected for fecal sample collection. Dietary treatments included a control top dress targeting a daily intake of 277 g of total dietary fiber (TDF) using ground corn (CON); a top dress consisting of wheat middlings, beet pulp, soy hulls, rice hulls, ground corn, and a stimbiotic (Signis, AB Vista) targeting an intake of 440 g of TDF per d with 40 g being soluble fiber (FIB); and FIB with 680 mg of vitamin C and 2,500 mg of yucca (PLUS). A total of 454 g of the respective top dress was provided on top of lactation diet for a minimum of 3 d pre-farrow, and throughout lactation. Litter performance was collected throughout lactation. A daily constipation score (DCS) was assessed using a five-point scale from study initiation until 3 d post farrowing: 0 = absence of feces, 1 = dry and pellet shaped, 2 = between normal and dry, 3 = normal, soft, but formed, and 4 = wet, not firm. Caliper score (CS) was measured at loading and weaning employing a four-point caliper system: 0 = very thin, 1 = thin, 2 = ideal, and 3 = over conditioned. Litter viability was evaluated at 24- and 72-h post-farrowing using a predefined scale. Categorical data was analyzed using odd logistic regression with a model considering treatment and block as fixed effects. By d 3 of supplementation, there was a greater proportion of gilts fed FIB or PLUS, who had a DCS of 2 or 3 (P &amp;lt; 0.05). Overall, when DCS was categorized as either constipated (0, 1) and not constipated (2, 3, 4), there were less incidences of constipation in FIB or PLUS treatments (P = 0.032). Treatment did not impact litter viability (24-h P = 0.917; 72-h P = 0.882). Similarly, CS distribution pre-farrowing and at weaning did not differ among treatments (P &amp;gt; 0.52). Gilts fed FIB and PLUS tended to wean more pigs per sow (86.9%, 88.6%, and 89.8% of pigs weaned for CON, FIB, and PLUS, respectively, P = 0.093), associated with reduced stillborn rate (P = 0.09) and pre-weaning mortality (P = 0.03). Collectively, increasing TDF during the periparturient and lactation period may aid in alleviating constipation and improve litter performance.

Exploring Attribute Associations in Pedestrian-Involved Hit-and-Run Crashes through Cluster Correspondence Analysis

Pedestrian-involved hit-and-run (PIHR) crashes represent a significant public health concern, and identifying patterns in these crashes can aid in developing effective countermeasures. Cluster correspondence analysis (CCA) is a multidimensional statistical technique that combines dimension reduction and clustering to identify patterns in categorical data. This method provides insights into underlying patterns and relationships among categories. The current study analyzed a Louisiana crash dataset of 2,201 PIHR crashes from 2015 to 2019 using CCA to identify underlying patterns. CCA identified six clusters, examined the top associative attributes, and assessed their cluster-to-dataset percentage ratio. The first two clusters, representing 66% of PIHR crashes, mainly involved crashes on city streets, occurring primarily during early night (7 to 11 p.m.) in Cluster 1 and the afternoon (12 noon to 4 p.m.) in Cluster 2. Clusters 3 and 4, accounting for 30% of PIHR crashes, predominantly exhibited crashes on U.S. and state highways. Cluster 4, which featured fatalities, primarily concentrated on state highways during the early morning hours (4 to 6 a.m.). Meanwhile, Clusters 5 and 6 focused on high-speed highways, specifically interstates involving pedestrian fatalities. A discussion on implementing strategic countermeasures tailored to the distinct characteristics of each cluster is presented. Alongside improvements in context-based countermeasures to ease pedestrian movement and enhance their visibility, strategies such as advocating for stringent hit-and-run laws, incentivizing the use of dashcams, and broadly publicizing resources for crash reporting are projected to be highly effective in curbing PIHR crashes.

Abstract PO4-23-05: Magnetic lymphatic tracing for omission of sentinel lymph node biopsies in mastectomy patients: a community cancer center experience

Abstract Background Patients with ductal carcinoma in situ (DCIS) and patients undergoing risk reduction mastectomy traditionally undergo sentinel lymph node biopsy (SLNB) at the time of mastectomy to complete axillary staging were invasive malignancy to be identified on final pathology. About 10% of patients with DCIS undergoing mastectomy will have invasive disease on final pathology; thus, about 90% would be able to avoid SLNB. Standard lymphatic mapping for SLNB includes a combination of radioisotope and blue dye, which have a short half-life. Superparamagnetic tracers, such as Magtrace®, are non-inferior to this standard and remain active for several weeks, allowing many patients to avoid SLNB in the setting of mastectomy. Reducing SLNB may also reduce associated risks with SLNB such as hematoma, seroma, and subsequent lymphedema. Objective We hypothesized using Magtrace® would reduce the number of SLNB in patients undergoing mastectomy for DCIS or risk reduction. Consequently, this would reduce the number of SLNB-associated complications. We report a community cancer center experience with Magtrace® for omission of SLNB in select mastectomy patients. Methods This was a retrospective review of 52 female patients with DCIS or known genetic predisposition undergoing mastectomy. Magtrace® was injected ipsilateral to DCIS or bilateral for prophylactic mastectomy patients. Our primary outcome was rate of return to the OR for delayed SLNB. Secondary outcomes included post operative complications within 30 days of surgery and OR time. We compared outcomes to a control group of 28 women undergoing mastectomy for DCIS or risk reduction who underwent SLNB at their index operation. Continuous variables were reported using median and interquartile range (IQR) and were compared using the Mann-Whitney U-test. Categorical data were reported using frequency and percent; they were compared using Pearson’s Chi-Square or Fisher’s Exact test, as appropriate. Alpha was set to 0.05 to determine statistical significance. Results There were a total of 80 patients (52 Magtrace®, 28 control). Median age of Magtrace patients was 49.5 (IQR 40-60.75) vs. 54.5 (IQR 48-65) years for the controls. 57.7% of Magtrace® patients underwent mastectomy for DCIS vs. 89.3% in the control group. 8 Magtrace® patients (15.4%) had invasive ductal carcinoma on final pathology and 7 of those patients underwent SLNB and none were positive for metastatic disease. Of these, 6 patients underwent mastectomy for DCIS. Average number of sentinel lymph nodes was 1.57 in Magtrace® patients and 1.60 in the control patients. Rates of post operative complications were similar between the groups, including hematoma, seroma, surgical site infection, skin necrosis. OR times were also similar with median OR time 202 minutes (min) for the Magtrace® group vs. 195 min for the control group. Conclusion Use of Magtrace® avoided SLNB in 84.6% of our patients. We found no difference in rates of postoperative complications or operative times in patients using Magtrace® for omission of SLNB at time of mastectomy compared to the control group. Our findings suggest SLNB can be avoided in a majority of patients undergoing mastectomy for DCIS or risk reduction in the setting of genetic predisposition. Table. Citation Format: Mia Samaha, Barbara Wexelman, Anne Kurtizky, Kathleen Raque, Angie Fellner. Magnetic lymphatic tracing for omission of sentinel lymph node biopsies in mastectomy patients: a community cancer center experience [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 PO4-23-05.

Abstract PO4-20-01: A PROSPECTIVE PILOT STUDY OF MAMMOGRAPHIC PREDICTION OF WOMEN’S RISK (M-POWER) IN NIGERIA

Abstract Background There have been no sustained efforts at stemming the rising incidence and mortality from breast cancer in sub-Saharan African countries like Nigeria. Mammography is the gold standard for breast cancer screening and is associated with improved survival particularly among women 50 to 69. Reports from various parts of Nigeria show very low mammography screening uptake. Causes include lack of geographical access, financial issues (less than 5% of the population is covered by the National Health Insurance Scheme), lack of awareness and the increasing expertise gap from the continued brain drain, despite the already low number of radiologists in the country. Given these obstacles, our long-term goal is to devise a rational basis for identifying mammographic risk categories so that this resource can be deployed cost-effectively. We propose to carry out a 5-year prospective mammographic study in Nigerian women and to use machine learning to develop a risk prediction algorithm, so that following a single screening mammogram, the appropriate frequency of subsequent mammograms can be determined. Our immediate goal is to examine the feasibility of performing such a study. To this end, we have initiated a cross-sectional pilot study that will recruit up to 2000 women in multiple urban centers in Nigeria. Objective: To explore feasibility of creating a digital mammography image database representative of the radiological features of the breast of Nigerian women. Objective: To explore feasibility of creating a database that can be used to inform a predictive mammographic risk model for breast cancer and identify the appropriate population that will benefit from breast cancer screening in Nigeria. Design This is a prospective, open-label, cross-sectional pilot study in 2000 eligible women in Nigeria and will include a single screening mammography examination. The mammography images will be read by the study radiologist. The Pilot phase will determine the feasibility and aid in the design of the of the Extension phase in which up to 20,000 participants will undergo yearly mammography examination for 5 years. Incident cases of breast cancer during the study period will permit the development of deep learning algorithms for predicting the risk of breast cancer in this population. Main Eligibility Criteria: Inclusion Criteria All consecutive women aged ≥40 years and &amp;lt; 65 years presenting for screening mammography at the participating institutions will be eligible. Signed study-specific written informed consent. Exclusion Criteria Complaint of a focal dominant lump or a bloody or clear nipple discharge. History of breast implants. Any woman who is pregnant or has reason to believe that she might be pregnant. Statistical Methods Analyses of continuous data will be summarized using descriptive statistics where the following parameters will be reported: Number of observations, Number of missing observations, Mean, Median, Standard deviation (SD), Minimum (Min), Maximum (Max) Categorical data will be presented with absolute and relative frequency (n and %). Present Accrual and Target accrual Two hundred ninety-six women have been enrolled and screening digital mammographic images using GE Digital mammography equipment have been obtained on all participants at 2 study sites in 2 cities in Southern Nigeria. The target accrual is 2000 participants over 12 months. Conclusion Our preliminary experience to date suggests the feasibility of proceeding with a larger prospective study to define mammographic risk groups in Nigerian women which will permit the rational allocation of resources for breast cancer prevention activities in this underserved population. Contact Information: Dr Toyin Shonukan at tshonukan@yemanjacancercare.org Citation Format: Oluwatoyin Shonukan, Hyelakumi Ibrahim, Esther Udoh, Wahab Egbeolu, Kanyinsola Oyeyinka, Jonas Haggstrom. A PROSPECTIVE PILOT STUDY OF MAMMOGRAPHIC PREDICTION OF WOMEN’S RISK (M-POWER) IN NIGERIA [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 PO4-20-01.

Abstract PO5-09-05: Characteristics of newly diagnosed breast cancer patients at a large safety-net system: Implications for health equity and care delivery

Abstract Introduction: Despite the increased awareness and advocacy for health equity, racial and socioeconomic disparities remain prevalent among breast cancer patients. Since lack of access to care is a major barrier, safety-net systems that provide services for the uninsured/underinsured play a significant role in promoting health equity and eliminating disparities. Understanding the patient population treated within these systems, which are often resource-limited, can help develop strategies to improve care delivery and outcomes. Here, we describe characteristics of breast cancer patients treated at a large safety-net system. Methods: Parkland Health (PH) is the safety-net system for Dallas County, and is affiliated with the University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center (NCI-CCC). Electronic medical records of patients with a new invasive breast cancer diagnosis between 2018 to 2020 at PH were reviewed and data on demographics and clinical presentation were collected. Categorical data was summarized with counts and percentages and continuous data was summarized with median and interquartile range. Statistical comparisons used Chi-square test for categorical data and rank sum test for continuous data with a significance level of 0.05. Data from the National Cancer Database (NCDB) for the same period was used for comparison. Results: A total of 657 patients at PH were included in the analysis (50.2% Hispanic; 32.3% Black). Median age at diagnosis was 53 years (range 46-61), with 39.1% of patients &amp;lt; 50 (12.3% &amp;lt; 40). The majority of patients were uninsured at the time of diagnosis (67.0%). Hispanic patients were younger than others (median age 49 years (range 43-57) vs 57 (range 48-63), p &amp;lt; 0.01), with 51.2% &amp;lt; 50. Late-stage diagnosis was observed in 30.6% of patients (stage III 16.4%, stage IV 14.2%), and triple negative breast cancer (TNBC) accounted for 22.8% of cases. While the stage distribution was not statistically different between racial and ethnic subgroups (p=0.66), black patients were diagnosed with TNBC at a significantly higher rate compared to others (30.2% vs 19.3%, p &amp;lt; 0.01). Although a trend towards higher rate of HER2(+) disease was noted among Hispanics, this difference did not reach the level of statistical significance (22.7% vs 16.5%, p=0.06). One hundred eighty-nine patients (28.8%) were diagnosed outside PH. Compared to Black patients, Hispanic patients were more often diagnosed in the community (22.2% vs 32.4%, p=0.01). Of the 564 patients with stage I-III, 340 (60.3%) had T2-4 and 203 (36.0%) had node positive disease at diagnosis. Median time to treatment initiation (TTI) was 51 days (range 35-76) and was significantly longer in patients who were diagnosed in the community compared to those diagnosed at PH, median 63 days (range 44-96) vs 48 (range 34-70), p &amp;lt; 0.01. Compared to the NCDB, PH patients were younger (39.1% vs 18.4% &amp;lt; 50 years, p &amp;lt; 0.01), presented at a higher rate with late-stage disease (30.6% vs 13.2%, p &amp;lt; 0.01) and TNBC (22.8% vs 10.7%, p &amp;lt; 0.01), and had a longer median time from diagnosis to treatment initiation - 51 days (range 35-76) vs 33 (range 21-49), p &amp;lt; 0.01. Conclusion: Breast cancer patients at PH were significantly different from the national average, with over a third below the USPSTF recommended breast cancer screening age. The rate of late-stage diagnosis at PH was more than two-fold the national average. Lowering the screening age to 40, expansion of outreach mammography programs, improving patient navigation, and simplifying access to indigent care programs are among strategies to promote health equity. Considering the high disease burden among safety-net patients, a systematic effort to increase resources at safety-net health systems is warranted. Citation Format: Sarah Kashanian, Shifa Kanjwal, L. Steven Brown, Andrea Semlow, Mary Hodges, Robyn Cobb, Brad Walsh, Umber Dickerson, Navid Sadeghi. Characteristics of newly diagnosed breast cancer patients at a large safety-net system: Implications for health equity and care delivery [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 PO5-09-05.

Abstract PO5-09-06: Outcomes of breast cancer in a minority-enriched population treated at a large safety-net system: Is site of care a predictor of poor outcomes?

Abstract Background: Breast cancer outcomes in the United States continue to improve, but sociodemographic disparities remain prevalent and impact care delivery and outcomes in vulnerable populations. Safety-net health systems are intended to address inequities by providing access to care for the uninsured/underinsured. Care delivery in a safety-net setting is often inherently complicated by limited resources at these institutions. Here, we present the overall survival (OS) data of breast cancer patients treated at a large safety-net system, compared to the national average. Methods: Parkland Health (PH) is the safety-net system for Dallas County and is affiliated with the University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center (NCI-CCC). Electronic medical records of patients diagnosed with invasive breast cancer between 2018 to 2020 at PH were reviewed and data on demographics, treatment, and outcomes were collected. Categorical data was summarized with counts and percentages and continuous data was summarized with median and interquartile range. Statistical comparisons used Chi-square test for categorical data and rank sum test for continuous data with a significance level of 0.05. Survival data was analyzed using Cox proportional hazard model. Data from the National Cancer Database (NCDB) for the same period was used for comparison. Results: Of the 657 patients included in the study, the majority (82.5%) belonged to racial and ethnic minorities (Hispanic 50.2%; Black 32.3%). Compared to the NCDB, PH patients were more often uninsured (67% vs 1.6%) or enrolled on Medicaid (14.5% vs 6.9%), and less often on Medicare (8.5% v. 43%) (p&amp;lt; 0.01). Triple negative breast cancer (TNBC) phenotype and late-stage diagnosis (stage III/IV) rates were higher at PH compared to NCDB (TNBC 22.8% vs 10.7%, p&amp;lt; 0.01; late stage 30.6% vs 13.2%, p&amp;lt; 0.01). At a median follow up of 33 (range 24-43) months in PH and 28 (range 21-36) months in NCDB, the unadjusted OS for the PH population was 86.3% vs 92.6% for the NCDB population (p &amp;lt; 0.01). Within the PH population, Black race, higher stage, and TNBC were associated with decreased OS. There was a significant interaction between Black race and TNBC. When combining all patients (PH+NCDB), site of care (PH) was associated with a higher risk of death from breast cancer (HR 1.467, 95% CI 1.192-1.805, p&amp;lt; 0.0005), however, multivariate analysis did not show a significant difference based on site of care. Factors associated with a significantly increased risk of death in this multivariate analysis (corrected for interaction between Black race and TNBC phenotype) included age, late-stage diagnosis, TNBC, Black race, and uninsured status (Table 1). Conclusions: Breast cancer patients treated at PH were more likely to have adverse disease characteristics compared to the NCDB population. When accounting for these risk factors in multivariate analysis, patients treated at PH had similar outcomes compared to the national average. Our findings reinforce the critical role of safety-net systems in promoting health equity and eliminating disparities. Table 1 Citation Format: Sarah Kashanian, Shifa Kanjwal, L. Steven Brown, Andrea Semlow, Mary Hodges, Robyn Cobb, Brad Walsh, Umber Dickerson, Navid Sadeghi. Outcomes of breast cancer in a minority-enriched population treated at a large safety-net system: Is site of care a predictor of poor outcomes? [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 PO5-09-06.

Abstract PO5-16-12: EFFICACY AND TOLERABILITY OF METRONOMIC CHEMOTHERAPY (mChT) WITH CYCLOPHOSPHAMIDE, METHOTREXATE AND CAPECITABINE (CMX) IN PATIENTS WITH HEAVILY PRETREATED ADVANCED BREAST CANCER. RESULTS FROM A MULTICENTER RETROSPECTIVE STUDY

Abstract BACKGROUND mChT consists on the administration of repetitive, low doses of chemotherapy drugs and represents an attractive and active therapeutic strategy in cancer patients. Beyond the traditional cytotoxic effect of each drug on tumor cells, mChT seems to play a role in the modulation of angiogenesis and immune-regulation. mChT has demonstrated promising clinical activity and low toxicity in patients with advanced breast cancer (ABC). The aim of this study is to describe the safety and efficacy of CMX in a retrospective cohort of heavily pretreated HER2-negative ABC patients. METHODS This is a multicenter, retrospective study that included patients with HER2-negative ABC who received treatment with CMX (capecitabine 500 mg thrice daily, methotrexate 2.5 mg twice a week, and cyclophosphamide 50 mg daily). Demographic data, tumor characteristics, previous therapies, efficacy, and toxicity of the CMX treatment were collected. Statistical analyses were performed with Stata v.14. For standard summary statistics, mean and range for continuous data and relative and absolute frequencies for categorical data were used while for survival analysis Kaplan Meier approach was employed. RESULTS A total of 25 patients from 4 centers in Spain treated between October 2016 and February 2023 were included in this analysis. Median age was 63 years (range: 37-87), 68% had visceral disease, and 48% had triple-negative tumors. All patients previously received a median of 5 prior lines of systemic therapy in the metastatic setting and 80% of patients had been treated with capecitabine, most of them in the metastatic scenario with a median treatment duration of 6.2 months. Dose reductions were necessary in 5 patients and 1 patient discontinued treatment due to toxicity. No grade 3-4 hand-foot syndrome or diarrhea were reported. Objective response rate was 20.8% and disease control rate was 54.2%. Median progression-free survival was 6.1 months (95% confidence interval [CI] 95%; 4.3 - 12.4) and median overall survival was 12.3 months (95% CI; 6.8 - 24.7). Neither the number of previous lines of treatment nor the prior use of capecitabine showed a negative impact on the efficacy of CMX. CONCLUSIONS CMX is an effective and well-tolerated scheme of mChT and may represent an adequate treatment option for patients with heavily pretreated HER2-negative ABC, including those patients that previously received capecitabine as single agent. These encouraging data warrant further investigation. Citation Format: Cristina Saavedra, María Gion, Alfonso Cortés, Patricia Cortez, Laia Garrigós, José Manuel Pérez-García, Gabriele Antonarelli, Javier Cortés. EFFICACY AND TOLERABILITY OF METRONOMIC CHEMOTHERAPY (mChT) WITH CYCLOPHOSPHAMIDE, METHOTREXATE AND CAPECITABINE (CMX) IN PATIENTS WITH HEAVILY PRETREATED ADVANCED BREAST CANCER. RESULTS FROM A MULTICENTER RETROSPECTIVE STUDY [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 PO5-16-12.

Abstract PO1-05-10: Clinical effectiveness of CDK4/6 inhibitors in HER2-low metastatic breast cancer

Abstract Introduction: There is growing evidence indicating that human epidermal growth factor 2 (HER2)-low is a unique subtype of breast cancer that comprises a substantial share of patients historically classified as HER2 negative. Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) are important in the treatment of hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC). Whether HER2-low status or the level of HER2 gene amplification have prognostic significance for HR+/HER2-negative MBC patients treated with ET and CDK4/6i remains an area of active investigation. Methods: Patients diagnosed with HR+/HER2-negative MBC and who were treated with palbociclib, ribociclib, or abemaciclib from 6/10/2015 to 12/28/2022 were selected from the Montefiore Health system database and followed until 3/24/2023. HER2-0 was defined as immunohistochemistry (IHC) 0, and HER2-low was defined as IHC 1+ or IHC 2+/in situ hybridization negative by 2018 ASCO/CAP guidelines. Median values were used to establish cutoffs for HER2/CEP17 ratio and HER2 gene copy number (GCN). Characteristics of the patients and tumors in the subgroups were compared using chi-squared/Fisher’s exact test for categorical data and Kruskal-Wallis/Wilcox signed rank tests for continuous data. Kaplan-Meier and Cox proportional hazards analysis were used to compare overall survival (OS) and progression free survival (PFS). Results: 239 patients received CDK4/6i, with 46 HER2-0 and 193 HER2-low patients. There was no statistically significant difference in clinicopathological characteristics between both cohorts. No significant differences were observed in median OS (36 vs 34 months, P &amp;gt; 0.9) and median PFS (44 vs 35 months, P = 0.4) between HER2-0 and HER2-low patients. Adjusting for HER2 status, multivariable analysis showed no statistically significant association between HER2-low status and worse OS (HR: 1.03, P = 0.9) or worse PFS (HR: 1.37, P = 0.4). The median HER2/CEP17 ratio was 1.25 (Interquartile range (IQR): 1.18-1.39), and the median HER2 GCN was 2.58 (IQR: 2.10-3.18). Median OS (25 vs 37, P = 0.15) and median PFS (35 vs 37, P = 0.15) showed no significant differences between ratio-below vs above-median patients. However, patients with GCN-below-median had significantly worse OS (25 vs 37 months, P = 0.026), with no significant difference in median PFS (38 vs 35 months, P = 0.3). Multivariate analysis revealed a significant effect of GCN-below-median on OS (HR: 0.50, P = 0.022) but not on PFS. Conclusion: The clinical effectiveness of CDK4/6i is not influenced by HER2-low status; however, the extent of HER2 gene amplification may have a substantial impact on therapy responsiveness in MBC patients undergoing CDK4/6i treatment. Table 1. Baseline characteristics of patients with MBC comparing HER2-0 vs HER2-low, above/below median HER2/CEP17 ratio, and above/below median HER2 GCN. Table 2. Median OS and PFS in patients with MBC comparing HER2-0 vs HER2-low, above/below median HER2/CEP17 ratio, and above/below median HER2 GCN. Table 3. Multivariable analysis of OS and PFS for patients with MBC comparing HER2-0 vs HER2-low, above/below median HER2/CEP17 ratio, and above/below median HER2 GCN. Citation Format: Frank Zhang, Jesus Anampa Mesias. Clinical effectiveness of CDK4/6 inhibitors in HER2-low metastatic breast cancer [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 PO1-05-10.

A Novel Approaches to Crop Variety Development for Sustainable Agriculture using Hybrid Machine Learning Model

The growing global population and changing climate need sustainable agriculture practices and new crop varieties. This study proposes a hybrid machine learning technique that combines linear regression and logistic regression to identify and extract unique traits from a broad range of crop species. The system integrates these qualities to create new crop types with a variety of benefits. The system begins by collecting detailed data on multiple crop species, including production potential, drought resilience, disease tolerance, nutritional content, and adaptation to different climates. Preprocessing ensures data quality. The hybrid machine learning algorithm uses the revised dataset. Linear regression identifies variables with strong connections with the required attributes, making it easier to find good candidates for the new crop variety. Logistic regression analyzes categorical data, including disease resistance genes and nutritional variables that affect crop quality. The method efficiently identifies and ranks the best characteristics across varied crop species by combining regression model findings. The traits have been strategically combined to create a pioneering cultivar that optimizes crop productivity, robustness, nutritional composition, and versatility while reducing vulnerability to pathogenic diseases and ecological challenges. The innovative crop variety is tested in various agricultural situations to determine the system's effectiveness. The topic under inquiry is compared to current kinds in terms of yield, quality, and sustainability. This unique hybrid machine learning technology may combine the best qualities from multiple sources to develop cutting-edge agricultural cultivars. The system's speed and accuracy in identifying beneficial traits promotes sustainable agriculture by reducing monospecific breeding and increasing crop resilience to environmental challenges. This work advances global food security and resource-efficient crop varieties.

Health Care Utilization by Patients With Chronic Pelvic Pain.

To describe the patterns of health care utilization among patients with chronic pelvic pain. Deidentified administrative claims data from the OptumLabs Data Warehouse were used. Adult female patients who had their first medical claim for chronic pelvic pain between January 1, 2016, and December 31, 2019, were included. Utilization was examined for 12 months after the index diagnosis. The greedy nearest neighbor matching method was used to identify a control group of individuals without chronic pelvic pain. Comparisons were made between those with and those without chronic pelvic pain using χ2 tests for categorical data and Wilcoxon rank-sum tests for continuous data. In total, 18,400 patients were analyzed in the chronic pelvic pain cohort. Patients with chronic pelvic pain had a higher rate of chronic overlapping pain conditions. Patients with chronic pelvic pain had higher rates of health care utilization across all queried indices. They had more outpatient office visits; 55.5% had 10 or more office visits. Patients with chronic pelvic pain showed higher utilization of the emergency department (ED) (6.3 visits vs 1.9 visits; P<.001). Urine culture and pelvic ultrasonography were the most utilized tests. One-third of patients with chronic pelvic pain utilized physical therapy (PT), and 13% utilized psychological or behavioral therapy. Patients with chronic pelvic pain had higher rates of hysterectomy (8.9% vs 0.6%). The average total health care costs per patient with chronic pelvic pain per year was $12,254. Patients with chronic pelvic pain have higher rates of chronic overlapping pain conditions and undergo more ED visits, imaging tests, and hysterectomies than patients without chronic pelvic pain. Improving access to multidisciplinary care, increasing utilization of interventions such as PT and psychological or behavioral therapy, and reducing ED utilization may be possible targets to help reduce overall health care costs and improve patient care.

Abstract PO3-05-09: The impact of body mass index on CDK4/6 inhibitor treatment survival outcomes in metastatic breast cancer

Abstract Introduction: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) are important in the treatment of hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC). Previous studies have shown that CDK4/6is affect metabolic processes and cell metabolism, including adipogenesis, lipid synthesis, and glucose regulation. Obesity has been associated with worse survival in breast cancer. We aimed to assess the effect of body mass index (BMI) on survival outcomes in patients treated with CDK4/6is for MBC. Methods: Patients diagnosed with metastatic HR+/HER2-negative BC and who were treated with palbociclib, ribociclib, or abemaciclib from 6/10/2015 to 12/28/2022 were selected from the Montefiore Health system database and followed until 3/24/2023. The patients were divided into three groups according to BMI level as follows; normal: 18.5-24.9 kg/m2, overweight: 25-29.9 kg/m2 and obese: ≥ 30 kg/m2. Patients were also stratified by BMI measured after 3 months of therapy. Characteristics of the patients and tumors in the subgroups were compared using chi-squared/Fisher’s exact test for categorical data and Kruskal-Wallis/Wilcox signed rank tests for continuous data. Kaplan-Meier and Cox proportional hazards analysis were used to compare overall survival (OS) and progression free survival (PFS). Results: Among 221 patients, 66 were normal weight, 78 were overweight, and 77 were obese. There was no statistically significant difference in clinicopathological characteristics among the cohorts. Neither BMI measured at baseline nor after 3 months of therapy had any association with OS (P = 0.8 at baseline and P = 0.1 after 3 months) or PFS (P = 0.4 at baseline and P = 0.6 after 3 months). Multivariable analysis showed no statistically significant association between BMI and worse OS (HR: 1.1 for overweight, P = 0.7; and 0.96 for obese, P = 0.9) or worse PFS (HR: 0.9 for overweight, P = 0.8; and 0.76 for obese, P = 0.5). Multivariate analysis revealed a significant effect of obese BMI after 3 months of treatment on OS (HR: 0.48, P = 0.035) but not on PFS (HR: 0.88, P = 0.8). Overweight BMI after 3 months of treatment was not found to have a significant effect on OS (HR: 0.49, P = 0.063) or PFS (HR: 0.89, P = 0.9). Conclusion: The clinical effectiveness of CDK4/6is was not found to be influenced by BMI measured prior to therapy; however, there may be an association between improved OS and obese BMI after 3 months of treatment. Median OS and PFS in patients with MBC comparing different BMI groups (normal, overweight, and obese) at baseline prior to therapy and after 3 months of therapy. Table 1 Baseline characteristics of patients with MBC comparing different BMI groups (normal, overweight, and obese) at baseline prior to therapy and after 3 months of therapy. Table 2 Table 3 Multivariable analysis of OS and PFS for patients with MBC comparing different BMI groups (normal, overweight, and obese) at baseline prior to therapy and after 3 months of therapy. Citation Format: Frank Zhang, Jesus Anampa Mesias. The impact of body mass index on CDK4/6 inhibitor treatment survival outcomes in metastatic breast cancer [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 PO3-05-09.

Multi-nutrients and periodontal disease - a new adjunct to improving treatment outcomes? A randomised placebo-control clinical trial.

This study by Laky et al. is a single-centre, double-blinded randomised placebo-controlled clinical trial, examining the effects of micronutrient supplementation in combination with non-surgical hygiene phase therapy (nsHPT)for Stage III and IV periodontal disease. The study was carried out at the Medical University of Vienna (Austria), School of Dentistry. The patients enrolled in the study were randomised to receive a commercially available multi-nutrient supplement (containing: vitamin C, vitamin E, zinc, selenium, alpha-lipoic-acid, cranberry extract, grapeseed extract, and coenzyme Q10) or a cellulose placebo to take for 2 months, alongside a course of non-surgical hygiene phase therapy. At baseline, the patients had a periodontal index screening (PSI) performed. Patients scoring >3 and meeting the inclusion criteria were enrolled in the trial. Oral hygiene instruction and patient education was performed, followed by 1 or more sessions of nsHPT depending on the clinical assessment of each patient, and a full periodontal probing depth (PPD) chart was recorded. The patients were then randomised to receive either the multi-nutrient supplement or the placebo to take twice daily for 8 weeks. Following this 8-week period the PPD as well as bleeding on probing (BOP), gingival recession (GR) and clinical attachment loss (CAL) were measured. The randomisation was carried out by a study-independent member of staff at the centre using a computer programme. A total of 149 patients were assessed for eligibility for this trial. Out of these patients, 83 were deemed to be unsuitable for the trial as they failed to meet the inclusion criteria, and 24 declined to participate. A total of 42 patients were then randomised to each arm of the study. The inclusion criteria included patients with Stage III and IV periodontal disease. Patients were deemed eligible if they met the following criteria: presence of 18 or more scorable teeth (excluding 3rd molars); >4 teeth with PPD of >6 mm; CAL > 5 mm, and no previous periodontal treatment in the past. Percentage bone loss at the most severe site, smoking status, and presence of diabetes and diabetic control were all taken into consideration. Patients were deemed ineligible for the trial if they were pregnant or under 18 years old. Exclusion criteria also included: recent periodontal abscess; a past or current co-morbidity which may confound the results of the study or endanger patients partaking in the study (i.e. malignancy, rheumatoid arthritis, and other severe systemic conditions); and obesity. PPD was used as the primary variable in this study. Other measured outcomes such as GR, CAL, BOP and other measurements taken, such as papillary bleeding index (PBI) and papillary inflamed surface area (PISA), were considered as secondary outcome variables. A variety of tests were used in order to assess the collected data. The Kolmogorov‒Smirnov test and Levene test were used for the equality of variances, and ICC and 95% CI were used when comparing periodontal chartings for PPD (in mm). Chi-square or Fisher tests were used for categorical data between intervention and placebo. The baseline and reevaluation data was compared using the McNemar test. All data was analysed using statistical software. Significant data is indicated by a p value < 0.05. The number of patients included for analysis was reduced to n = 20 for the intervention group and n = 19 for the placebo group. Patients were lost due to a variety of reasons including need for antibiotics and lost to follow-up. The authors concluded that in each arm of the trial, periodontal and hygiene parameters improved overall. The results show that the intervention group had a significantly higher reduction in PPD; however, following data analysis, these findings were found to be statistically insignificant. The authors conclude that the addition of a multi-nutrient supplement, alongside nsHPT for patients undergoing treatment for Stage III and IV periodontal disease, showed a reduction in PPD and BOP when compared with a placebo and nsHPT.