Non-randomized Design Research Articles

Effect of Bilingual Instruction-Mode on Pre-Service Integrated Science Teachers’ Cognitive and Practical Skill Achievements in Ecology

Nigeria is a multilingual country with diverse cultural background. The language (English) used when Nigeria was a British Colony is still the only official language and medium of instruction in the Nigerian schools. The purpose of this study therefore is to investigate the effect of bilingual (English and English-Yoruba) instruction-mode on cognitive achievement and practical skill achievements in ecology among colleges of education integrated science students in Lagos State, Nigeria. A 2x2 pretest posttest nonrandomised quasi-experimental design was adopted for the study. The sample comprised two hundred and eighty-five year two integrated science students from Adeniran Ogunsanya College of Education, Otto/Ijankin, Lagos and Federal College of Education (Technical), Akoka, Lagos. Ecology Cognitive Achievement Test (ECAT) and Ecology Practical Skills Achievement Test (EPSAT) were the two instruments used to collect data for the study. The two research questions and null hypotheses formulated were analysed with mean, standard deviation and t-test at 0.05 alpha level using Statistical Package for Social Science (Version 23.0). Results showed that there is statistical significant effect of the treatment (bilingual instruction-mode) on the cognitive achievement of students in ecology concepts [t(283)=9.583; p<.05]. Mean score of Bilingual teaching strategy is (=12.669) and control group scored the least (=9.683) in achievement in Ecology. Study finding also revealed statistical significant effect of the treatment on the practical skills achievement of students [t(283)=13.917; p<.05]. The study, therefore recommends, inter-alia, that integrated science teachers should utilize bilingual approach to support teaching of integrated science in Nigeria tertiary institutions to enhance students’ academic performance.

Exploring the potential of YouTube videos towards enhancing achievement and retention of undergraduate students in environmental education

The poor performance of students in environmental education calls for different approaches towards teaching of the course of which the incorporation of technology is one of them. Hence, this study investigated the effect of YouTube-supported instructional strategy on academic achievement of environmental education students in University of Abuja, Nigeria. The study adopted a one group pre-/post-test quasi-experimental non-equivalent, non-randomized control group design. The population of the study comprised of 768 year three undergraduate students of Department of Science and Environmental Education, Faculty of Education at University of Abuja. A purposive sampling technique was used to select 126 year three students of environmental education in Department of Science and Environmental Education offering EED 322: Natural ecosystem. The instruments for the study were environmental education achievement test (EEAT) and YouTube videos used as test and treatment instruments, respectively. The instruments were validated by experts in the field of educational technology and environmental education. EEAT was tested using split-half method of reliability and a co-efficient value of 0.89 was obtained using Pearson product moment correlation. The findings revealed that the students performed better in the post-test (mean gain=40.01) and retention test (mean loss=2.01) after exposure to tailored YouTube videos matching their lecture contents and that a significant difference was found in the students’ achievement (t=5.21, p=.000) and retention scores (t=2.44, p=.000). It was therefore recommended, amongst others, that lecturers should adopt the use of YouTube videos in teaching and learning for they are effective.

Quality of Life and Patient-Reported Outcomes Following Proton Therapy for Oropharyngeal Carcinoma: A Systematic Review

Complex anatomy surrounding the oropharynx makes proton therapy (PT), especially intensity-modulated PT (IMPT), a potentially attractive option due to its ability to reduce the volume of irradiated healthy tissues. Dosimetric improvement may not translate to clinically relevant benefits. As outcome data are emerging, we aimed to evaluate the evidence of the quality of life (QOL) and patient-reported outcomes (PROs) following PT for oropharyngeal carcinoma (OC). We searched PubMed and Scopus electronic databases (date: 15 February 2023) to identify original studies on QOL and PROs following PT for OC. We employed a fluid strategy in the search strategy by tracking citations of the initially selected studies. Reports were extracted for information on demographics, main results, and clinical and dose factor correlates. Quality assessment was performed using the NIH's Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. The PRISMA guidelines were followed in the preparation of this report. Seven reports were selected, including one from a recently published paper captured from citation tracking. Five compared PT and photon-based therapy, although none were randomized controlled trials. Most endpoints with significant differences favored PT, including xerostomia, cough, need for nutritional supplements, dysgeusia, food taste, appetite, and general symptoms. However, some endpoints favored photon-based therapy (sexual symptoms) or showed no significant difference (e.g., fatigue, pain, sleep, mouth sores). The PROs and QOL improve following PT but do not appear to return to baseline. Evidence suggests that PT causes less QOL and PRO deterioration than photon-based therapy. Biases due to the non-randomized study design remain obstacles to a firm conclusion. Whether or not PT is cost-effective should be the subject of further investigation.

To experiment or not to experiment in tax policy?

Despite the increasing use of experiments in policy-making the suitability of experimenting in the public sector context is still under debate. In this article, we focus on experimenting in the field of tax policy and ask: what are the promises and pitfalls of using experimental approaches in tax policy? While the existing discussions on tax policy experimentation focus on randomized controlled trials from a legal perspective, we adopt a broader view and provide a more comprehensive discussion by synthesizing insights from the fields of political science, public policy, public administration, and governance. Our analysis encompasses randomized controlled trials, non-randomized policy pilots and design experiments. We summarize the existing knowledge on using experimental approaches in policy-making and discuss the implications of the knowledge for experimenting in tax policy. We seek to offer a more holistic and critical take on whether we should promote the use of experimental approaches in this domain.

Comparative Effect of use of Graphic Organizers on Students’ Learning Outcomes in Organic Chemistry

The purpose of this study is to determine the comparative effectiveness of the use of concept map and mind map graphic organizers on students’ learning outcomes in organic chemistry. This research adopted a quasi-experimental design involving a 3X2 pre-test post-test non-randomized and non-equivalent control group design. The study is premised on the dual coding theory of cognition, and involved 183 respondents whom were purposively selected from three intact classes. Data for the study was gathered through an organic chemistry achievement test whose reliability was determined through a test retest method and a reliability index of 0.74 was obtained. Data was analyzed using t-test and Analysis of Covariance. Findings show that there was a significant difference between the achievement of students taught organic chemistry using concept map graphic organizers and those taught with the mind map graphic organizer (F(1,118)= 7.04, p<.05). Using t-test statistics, findings also indicated that there was no significant difference in the achievement of male and female students when exposed to either concept map (t(75)= .47, p = .63) or mind map graphic organizer (t(42)= .64, p = .52). Hence, it was concluded that mind map is a more effective tool for learning organic chemistry when compared to the concept map. Irrespective of students’ gender, either of concept map or a mind map can help improve students’ achievement in organic chemistry.

Abstract 4359: Interventions to improve pathologic nodal staging of curatively resected lung cancer: A population-based implementation study

Abstract Introduction. Despite its importance, pathologic nodal (pN) staging of lung cancer remains poor. We evaluated the quality and survival impact of two interventions to improve pN staging. Methods. Using a non-randomized stepped-wedge design, we implemented use of a lymph node (LN) specimen collection kit to improve intraoperative LN collection (surgical intervention) and a novel gross dissection method for intrapulmonary LN retrieval (pathology intervention) in 12 hospitals in five contiguous Hospital Referral Regions in AR, MS and TN (2009-2021). With appropriate statistical methods we compared surgical quality and survival of patients among: neither (Group 1), pathology only (Group 2), surgical only (Group 3), and both (Group 4) interventions. Results. Of 4,019 patients, 50%, 5%, 21% and 24%, were in Groups 1-4 respectively. Rates of non-examination of LNs and non-examination of mediastinal LNs: 11%, 9%, 0% and 0%; 29%, 35%, 2% and 2% respectively in Groups 1-4 (p<0.0001). Attainment of American College of Surgeons Operative Standard 5.8: 22%, 29%, 72%, 85%; International Association for the Study of Lung Cancer’s stringent definition of ‘complete resection’: 14%, 21%, 53%, 61% (p<0.0001). Compared to Group 1, adjusted hazard ratios, aHR (95% CI), were: Group 2, 0.93 (0.76-1.15); Group 3, 0.91 (0.78-1.03); Group 4, 0.75 (0.64-0.87). Compared to Group 2, Group 4 aHR- 0.72 (0.57-0.91); compared to Group 3, was 0.83 (0.69-0.99). These relationships remained after excluding wedge resections. Discussion. Combining a LN collection kit and novel gross dissection method significantly improved pN evaluation and survival in a population-based cohort. Citation Format: Meredith A. Ray, Carrie Fehnel, Olawale Akinbobola, Andrea Saulsberry, Kourtney Dortch, Anberitha Matthews, Amal Anga, Christopher Giampapa, Elizabeth Sales, Sherry Okun, Edward T. Robbins, Bradley Wolf, Paul Levy, Horace L. Wiggins, Thomas Ng, Vishal Sachdev, Ganpat Valaulikar, Hetal D. Patel, Nicholas R. Faris, Matthew Smeltzer, Raymond U. Osarogiagbon. Interventions to improve pathologic nodal staging of curatively resected lung cancer: A population-based implementation study. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4359.

Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: A narrative review.

This narrative review describes the application of negative control outcome (NCO) methods to assess potential bias due to unmeasured or mismeasured confounders in non-randomized comparisons of drug effectiveness and safety. An NCO is assumed to have no causal relationship with a treatment under study while subject to the same confounding structure as the treatment and outcome of interest; an association between treatment and NCO then reflects the potential for uncontrolled confounding between treatment and outcome. We focus on two recently completed NCO studies that assessed the comparability of outcome risk for patients initiating different osteoporosis medications and lipid-lowering therapies, illustrating several ways in which confounding may result. In these studies, NCO methods were implemented in claims-based data sources, with the results used to guide the decision to proceed with comparative effectiveness or safety analyses. Based on this research, we provide recommendations for future NCO studies, including considerations for the identification of confounding mechanisms in the target patient population, the selection of NCOs expected to satisfy required assumptions, the interpretation of NCO effect estimates, and the mitigation of uncontrolled confounding detected in NCO analyses. We propose the use of NCO studies prior to initiating comparative effectiveness or safety research, providing information on the potential presence of uncontrolled confounding in those comparative analyses. Given the increasing use of non-randomized designs for regulatory decision-making, the application of NCO methods will strengthen study design, analysis, and interpretation of real-world data and the credibility of the resulting real-world evidence.

Online and onsite supervised exercise therapy and education for individuals with knee osteoarthritis - A before and after comparison of two different care delivery models.

To compare the 3 and 12-month changes on pain, function and quality of life between online and onsite delivery of Good Life with Osteoarthritis in Denmark (GLA:D® ) in individuals with knee osteoarthritis (OA). Non-inferior comparison of individuals with knee OA receiving physiotherapist-supervised online (TeleGLA:D) or onsite (GLA:D®) (12 exercise and 2 education sessions). The primary outcome was the baseline-to-3-month change on KOOS-12 summary score. Secondary outcomes were changes in KOOS-12 subscales pain, function and quality of life and pain intensity (Visual Analog Scale (VAS 0-100)) at 3 and 12months; 40m fast-paced walk and 30s chair-stand at 3months. Using mixed linear regressions, comparisons were adjusted for age, sex, BMI, comorbidities and number of knees and hips with OA. Over a 1-year period (May 2020-May 2021), we included data from 3789 participants (3701 GLA:D®; 88 TeleGLA:D). At 3months, TeleGLA:D showed non-inferior change-scores to GLA:D® on KOOS-12 summary score; adjusted mean difference (90% Confidence Intervals (CI)) -2.40 (-5.55 to 0.75). For secondary outcomes, there was a statistically significant difference in change-scores, favouring TeleGLA:D in gait speed; adjusted mean difference (90%CI) 0.23m/s (0.18-0.27). TeleGLA:D remained non-inferior to GLA:D® at 12months. Online delivery of physiotherapist-supervised neuromuscular exercise and education for individuals with knee OA may be non-inferior to traditional onsite delivery in reducing pain and improving function and quality of life. The wide confidence intervals, baseline imbalance, loss to follow-up and the non-randomized design highlight the need for a confirmatory randomized controlled trial.

Use of cytokine-induced killer cell therapy in patients with colorectal cancer: a systematic review and meta-analysis

BackgroundThe number of clinical studies evaluating the benefit of cytokine-induced killer cell (CIK) therapy, an adoptive immunotherapy, for colorectal cancer (CRC) is increasing. In many of these trials, CIK therapy...

An Interactive Communication Model for Self-Care—Regardless of Health Literacy: Protocol for a Quasi-Experimental Study

Clear dialogue-based (interactive) communication that ensures comprehension and recall becomes more important in patient-provider interactions, especially in relation to patients with chronic diseases, where self-management education and counseling are cornerstones in managing these diseases. If patients with chronic disease experience challenges in obtaining, understanding, and applying health-related information (necessary to make informed health decisions and sufficiently manage their health), clear communication and ensuring comprehension become even more critical in the patient-provider interactions. Furthermore, patient-provider communication has been proposed as a potential pathway through which health literacy might influence health outcomes, especially in individuals with chronic diseases. Hence, adjusting communication to the individual level of health literacy might have a positive influence on health outcomes. On this basis, the authors have developed a web-based interactive communication model that both seeks to accommodate health literacy by allowing tailored communication and ensure comprehension and recall between nurses and patients. This study seeks to examine the use of an IT solution that comprises an interactive communication model that seeks to accommodate health literacy in communication and ensure comprehension and recall between nurses and patients. A quasi-experimental control group study including full economic evaluation with 6-month follow-up. Based on power calculation, a total of 82 participants will be included. Participants are assigned either the interactive communication model (intervention) or usual nursing care. It will be assessed if the model influences the level of health literacy and participants experience a higher health-related quality of life. Further, cost-effectiveness will be evaluated. Overall, the statistical methods will follow an intention-to-treat principle. Results will be presented in accordance with the Transparent Reporting of Evaluations with Non-randomized Designs guidelines for nonrandomized designs as well as the Consolidated Health Economic Evaluation Reporting Standards. This paper describes a protocol for a clustered quasi-experimental control study that seeks to evaluate the effectiveness of the interactive communicative model. Most studies in the field of health literacy are epidemiological studies that seek to address the effects of poor health literacy in populations and its potential impact on health inequity. A total of 82 participants, who receive community nursing will be included. The final trial day is May 1, 2022, with the first report of results in the final quarter of 2022. The results of the trial can create the base for conducting a large-scale study and inspire the conduction of more studies that seeks to create and evaluate interventions aimed at enhancing the level of health literacy and reducing the usage of health resources. ClinicalTrials.gov NCT04929314; https://clinicaltrials.gov/ct2/show/NCT04929314. DERR1-10.2196/37673.

Dentoskeletal and soft-tissue changes of class II malocclusion treatment with modified first class appliances: a prospective clinical trial.

Intraoral distalizers are effective and conservative alternatives for Class II malocclusion treatment. However, the literature is still controversial regarding the effects of using skeletal anchorage in intraoral distalizers with different designs. The aim of this study is to compare dentoskeletal and soft-tissue changes of Class II malocclusion patients treated with three types of First Class (FC) distalizers. The sample of this prospective clinical trial included 30 consecutive patients divided into three groups: G1-FC conventionally anchored; G2-FC skeletally anchored Type 1; G3-FC skeletally anchored Type 2. Each group consisted of 10 patients. Lateral cephalograms were analyzed in two stages: at pre-treatment (T0) and after distalization (T1). The radiographs were digitized and analyzed using the software Dolphin Imaging 11.5. Comparisons of treatment changes between groups (T1-T0) were performed using one-way analysis of variance (ANOVA), followed by the Tukey test. Patients treated with the conventionally anchored FC showed significantly greater incisors protrusion and labial inclination, second premolars mesial inclination and mesialization than the FCs skeletally anchored. No differences were observed regarding the amount of molar distalization and molar angulation between groups. It can be considered that the limitation of this study lies in its non-randomized design. First Class distalizers with conventional and skeletal anchorage are effective alternatives for Class II molar distalization. Distalization associated with indirect skeletal anchorage reduce the undesirable effects observed in the incisors and premolars during distalization when compared to distalization conventionally anchored.

Guided Discovery Learning-Based Chemistry E-Module and Its Effect on Students' Higher-Order Thinking Skills

This study aims to analyze the effectiveness of guided discovery learning-based e-modules in improving senior high school students' higher-order thinking skills. It belongs to quasi-experimental research with a nonrandomized control-group pretest-posttest design. Three schools in Padang, Indonesia, were chosen as the samples through a purposive sampling technique, and experimental and control classes in each school were assigned based on the homogeneity of their previous academic score. Research instruments were a higher-order thinking cognitive test using multiple-choice questions and worksheets in the guided discovery learning-based e-module made for salt hydrolysis, electrolyte and nonelectrolyte solutions, and chemical elements. Students' test scores were analyzed using the N-gain test and independent sample t-test. The results show that students' higher-order thinking skills in the experimental classes were significantly higher than in the control classes. Most students could fill in the worksheets in the e-modules whose problems were made according to higher-order thinking skills criteria. Multiple representations integrated with learning materials in the e-modules helped students understand chemistry concepts. The ordered stages of guided discovery learning integrated with complete and interactive multimedia in the e-modules facilitated students to engage in learning, investigating, and evaluating information to conclude; the attempts to train higher-order thinking skills. Therefore, it can be concluded that guided discovery learning-based chemistry e-module can effectively improve senior high school students' higher-order thinking skills.

A theory-driven, culture-tailored educational intervention for cervical cancer screening among rural Chinese females: A feasibility and pilot study

ObjectiveThis study aimed to evaluate the feasibility and preliminarily estimate the effects of a theory-driven, culture-tailored, community-based educational intervention promoting cervical cancer screening among rural females. MethodsAn experimental study with the two-arm parallel, nonrandomized control trial design was implemented, followed by individual semi-structured interviews. Thirty rural females between 26 and 64 were recruited, with 15 in each group. Both groups were exposed to the usual care about cervical cancer screening promotion from the local clinics, while participants in the intervention group additionally received five educational sessions in 5 weeks. Data were collected at baseline and immediately postintervention. ResultsAll participants completed the study, and the retention rate was 100%. Participants in the intervention group had more significant increments in cervical cancer screening-related self-efficacy (P ​< ​0.001), knowledge (P ​< ​0.001), and intention levels (P ​= ​0.003) than those in the control group. Most participants showed acceptance and satisfaction with this educational intervention. ConclusionsThis study revealed that the theory-driven, culture-tailored, community-based educational intervention was feasible among the rural populations to promote cervical cancer screening. A large-scale interventional study with a prolonged follow-up duration is warranted to explore this educational intervention's effectiveness further.

Enhancing cultural competency and empathy toward foreign patients for Korean nursing students through a simulation: A quasi-experimental study

AimThis study aimed to develop a transcultural nursing simulation-based learning program with patients from the United Arab Emirates and evaluate its effects on cultural competence and empathy among undergraduate nursing students in South Korea. BackgroundThe importance of cultural competency and empathy has increased with the increased number of foreign patients in Korea. The United Arab Emirates (UAE) is one of the top Middle Eastern countries from which patients visit Korea for medical services. Because South Korea is a largely homogenous country, foreign patients often experience difficulties in their hospitalizations when Korean nurses lack cultural competency in caring for them. To improve cultural competency, a practical form of education, such as a simulation, is necessary. In addition, the simulation module based on cultural competency model allowing nursing students to provide effective and culturally responsive services to ethnically diverse patients. DesignThis quasi-experimental study used a non-randomized control group design with a convenience sample. MethodsThe program was administered to 53 Korean undergraduate nursing students (26 control and 27 experimental). Fourteen teams of two students practiced infection prevention training with the mother of a 7-year-old child with immunodeficiency. Participants’ cultural competency and empathy were assessed before and after the TN-SBL using an online survey. The effects of cultural competency and empathy were analyzed using a generalized estimation equation. ResultsNursing students in the TN-SBL group showed more positive improvement in cultural competence and had increased cognitive empathy levels than students in the control group. ConclusionThe simulation module developed in this study improved students’ cultural competency and empathy levels. It is valuable because the scenario was developed based actual clinical cases of Emirati patients and their families. The simulation module was designed based on the cultural competency model to raise awareness of cultural diversity and allow students to directly practice culturally competent care. It can be used to educate Korean nurses and improve the quality of care provided to Arabic-speaking Muslim patients.

New therapies in non-small cell lung cancer with EGFR exon 20 insertion mutations.

Patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations have a poor prognosis and few therapeutic alternatives. We conducted a review of scientific evidence about therapies in NSCLC with EGFR exon 20 insertion mutations. A systematic review in PubMed® database was performed up to November 19, 2022. Clinical trials (CTs) about treatments of patients diagnosed with advanced or metastatic NSCLC harbouring EGFR exon 20 insertions who had previously received platinum-based chemotherapy were selected. CTs with a sample size of less than 10 patients were discarded. Efficacy results were used to determine the most interesting drugs. Subsequently, a more exhaustive analysis of the design of the CTs and safety of the most interesting schemes was conducted. Comparisons were attempted to develop. A total of 40 records were found in the systematic search. Twelve selected CTs included the following therapies: poziotinib, osimertinib, pertuzumab-trastuzumab-docetaxel scheme, mobocertinib, amivantamab, erlotinib-onalespib regimen, luminespib, ado-trastuzumab emtansine and dacomitinib. Mobocertinib, amivantamab and poziotinib were determined as the most interesting treatments according to efficacy data. Gastrointestinal and dermatological adverse reactions were relevant in these regimens. All CTs presented a non-randomised design. No reliable comparisons could be developed. The efficacy of mobocertinib, amivantamab and poziotinib in NSCLC with EGFR exon 20 insertion mutations is promising. However, therapies were assessed in single-arm CTs with low-quality evidence. Comparative studies with more extensive patient follow-up, larger sample size and better design are needed to reliably quantify the effect of these drugs.

Biopsychosocial effects and experience of use of robotic and virtual reality devices in neuromotor rehabilitation: A study protocol.

Robot-assisted therapy (RAT) and virtual reality (VR)-based neuromotor rehabilitation have shown promising evidence in terms of patient's neuromotor recovery, so far. However, still little is known on the perceived experience of use of robotic and VR devices and the related psychosocial impact. The present study outlines a study protocol aiming to investigate the biopsychosocial effects and the experience of use of robotic and non-immersive VR devices in patients undergoing neuromotor rehabilitation. Adopting a prospective, two-arm, non-randomized study design, patients with different neuromotor diseases (i.e., acquired brain injury, Parkinson's Disease, and total knee/hip arthroplasty) undergoing rehabilitation will be included. In a real-world clinical setting, short- (4 weeks) and long-term (6 months) changes in multiple patient's health domains will be investigated, including the functional status (i.e., motor functioning, ADLs, risk of falls), cognitive functioning (i.e., attention and executive functions), physical and mental health-related quality of life (HRQoL), and the psychological status (i.e., anxiety and depression, quality of life satisfaction). At post-intervention, the overall rehabilitation experience, the psychosocial impact of the robotic and VR devices will be assessed, and technology perceived usability and experience of use will be evaluated through a mixed-methods approach, including both patients' and physiotherapists' perspectives. Repeated measures within-between interaction effects will be estimated, and association analyses will be performed to explore the inter-relationships among the variables investigated. Data collection is currently ongoing. The biopsychosocial framework adopted will contribute to expanding the perspective on patient's recovery within the technology-based rehabilitation field beyond motor improvement. Moreover, the investigation of devices experience of use and usability will provide further insight into technology deployment in neuromotor rehabilitation programs, thereby maximising therapy engagement and effectiveness. ClinicalTrials.gov ID: NCT05399043.

Automatic Stop Orders for Opioids

&#x0D; Automatic stop orders may reduce or have no significant effect on opioid-based prescriptions at the institutional level.&#x0D; We did not find any evidence regarding a range of clinical outcomes (e.g., rates of opioid dependence, misuse, and diversion; reduction in opioid dependence, health-related quality of life, and adverse events) associated with automatic stop orders.&#x0D; We did not find any evidence-based guidelines regarding the use of automatic stop orders for opioid prescriptions.&#x0D; Given the limited number and observational, nonrandomized design of the included studies, as well as the absence of any evidence-based guidelines regarding the use of automatic stop orders for opioid prescriptions, it was difficult to draw any firm conclusions about the clinical effectiveness of automatic stop orders for opioid prescriptions in the Canadian context.&#x0D;

Abstract OT3-21-01: A pilot study of robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction using da Vinci SP ® single-port system

Abstract Introduction- Robotic mastectomy is a novel breast surgery approach accessed from a concealable anterior axillary incision showing better cosmetic outcomes with a scarless front view. The oncological safety awaits further follow-up from clinical trials or registered studies to mature. Compared to older da Vinci systems with multiple arms, the new SP system is single-armed, equipped with flexible instruments and a camera that may avoid instrument collision and dead spots in the surgical field. This trial (NCT05448963) is not only the leading SP mastectomy trial in Asia but also the first one that incorporates autologous flap reconstruction. Methods- -Objectives: To determine the performance, technical algorithm, safety data, and patient-reported outcomes in single-port-accessed nipple-sparing mastectomy using da Vinci SP® system. -Study design: This study is a pilot clinical study conducted in a single-arm, non-randomized design with a goal to recruit 30 participants. The da Vinci SP ® surgical robot is applied in the nipple-sparing mastectomy and axillary lymph node dissection (if indicated) of each enrolled patient in Chang Gung Memorial Hospital Linkou Medical Center. The post-mastectomy reconstructive method may use autologous flaps or implants depending on the type of build, technical feasibility, and flap site availability of the patient. The eligibility criteria include: I. Meet at least one of the following indications of NSM for breast cancer: 1. Preoperative clinical tumor sizes less than 5 cm, with an adequate tumor-skin distance of at least 3mm and above, and without nipple-areolar involvement in at least 1cm around the nipple by image 2. Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meeting criteria 1. 3. Germline pathogenic/likely pathogenic BRCA1 or 2 mutation carriers (actionable mutations including pathogenic and likely pathogenic mutations) with a breast cancer diagnosis or requiring unilateral or bilateral prophylactic mastectomy as a risk reduction procedure II. Age equal to or above 20 years III. ECOG (Eastern Cooperative Oncology Group) performance score 0-1 IV. ASA anesthesia risk class 1~2, and with adequate organ functions Endpoint measures: -Primary endpoint: Ability to complete nipple-sparing mastectomy with da Vinci SP system in the per-protocol population. -Secondary endpoints: Safety measured by adverse events through 30-day post-operative follow up -Exploratory endpoints: Surgical time, blood loss, hospital stay, breast specimen weight, cancer resection margin, nipple-preservation rate morbidity and mortality rate within 30 days of operation, and reoperation within 30 days post-surgery -Statistical analysis: Point estimation with a 95% confidence interval will be used to analyze the mean or proportion of key performance parameters. No interim analysis will be performed due to the limited number intended to recruit. -Trial status: Active recruitment Conclusion: The single-port robotic system features single port access with multi-jointed instruments which is particularly designed for narrow surgical spaces such as mastectomy. The feasibility of applying da Vinci SP systems to robotic nipple-sparing mastectomy and robiotic axillary lymph node dissection will be demonstrated in this study. Citation Format: Wen-Ling Kuo, Chia-Huei Chu, Jung-ju Huang. A pilot study of robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction using da Vinci SP ® single-port system [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-21-01.

COMPARISON BETWEEN ANTHROPOMETRIC MEASUREMENT RESULTS BY CADRES AND MEDICAL PROFESSION STUDENTS USING TIPS (TIKAR PENDETEKSI STUNTING)

Stunting prevalence in District Kalipare on February 2019 was about 14%. Based on the results of the preliminary studies, one of the obstacles to achieving a free stunting rate is caused by anthropometric measurement errors by cadres. The objective of this study was to compare cadres of District Kalipare anthropometric measurement results with medical profession students' anthropometric results using the Tikar Pendeteksi Stunting (TIPS). This quasi-experimental study was conducted using a non-randomized control group pretest-posttest design. The sample of toddlers is 51 toddlers. The experiment was carried out by training 50 community-based health or posyandu cadres who were representatives from 8 villages in Kalipare District. Of the 50 cadres, 25 were selected by purposive sampling according to posttest scores per village. The selected cadres were asked to measure 1-3 infants or toddlers who had previously been measured before attending the training. The variables studied were nutritional status and height. The results showed that the Kappa test obtained a value of p = 0.838 or very good agreement. This study concludes that the results of height measurements by toddler posyandu cadres are the same as or close to the results of height measurements carried out by medical profession students. Therefore, after they have received training, we can include posyandu cadres in measuring anthropometrics.

Sotrovimab for the Treatment of COVID-19

&#x0D; Sotrovimab may not have clinical effectiveness in treating Omicron subvariant BA.2.&#x0D; This finding generally aligns with the Health Canada and WHO recommendations and the findings of previously published in vitro studies against the use of sotrovimab for Omicron subvariants, except for BA.1.&#x0D; Given the limited number and observational, nonrandomized design of the included studies, and the absence of evidence on the clinical effectiveness of sotrovimab for outpatients with confirmed COVID-19 Omicron subvariants BA.3 to BA.5, it was difficult to draw a firm conclusion about the clinical effectiveness of sotrovimab for Omicron subvariants.&#x0D;