title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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However, patients excluded from the study complied with: | enamel hypoplasia, cavitated lesions | DENTAL FLUOROSIS, ENAMEL HYPOPLASIA, MEDICAL COMPLICATION |
Participant in another trial [Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia to avoid any false-positive results [Participants who had evidence of reduced salivary flow, systemic, or medical complications [Participants with cavitated lesions [Eligible patients were recruited from the o... | PMC9889428 |
Random sequence generation (randomization) | Simple randomization was assigned for participants by generating numbers from 1 to 58 using Random Sequence Generator, Randomness and Integrity Services Ltd ( | PMC9889428 | ||
Allocation-concealment mechanism | The allocation of remineralizing agents to groups was performed through an opaque sealed envelope to ensure complete concealment. Figure | PMC9889428 | ||
Blinding | The patient and assessors were blinded to the material assignment while the operator did not, due to the difference in material presentation and its application protocol. | PMC9889428 | ||
Clinical examination of white spot lesions | WSLs, dryness | DEMINERALIZATION, OPACITY | Full dental and medical history for the patients was taken. A clinical examination of an active white spot lesion was performed to assess the color on the labial aspect of anterior teeth. WSLs defined as “white opacity” occur because of subsurface enamel demineralization that is located on smooth surfaces of teeth. The... | PMC9889428 |
Material application | strokes, tooth | PLAQUE, STROKES | Clinpro White Varnish, 3 M ESPE, 5% sodium fluoride was applied under manufacturer instructions as follows: dryness of the affected tooth was unnecessary as it sets in presence of saliva. Then, a thin layer of varnish was applied with a brush in strokes. No rinsing, suction, or drying was required. The patient was inst... | PMC9889428 |
Statistical methods | This study was performed to compare the qualitative and quantitative effects of two remineralizing agents on post-orthodontic white spot lesions comprising different theories. The first remineralizing agent is the self-assembling peptide P11-4 which follows the non-classical theory of remineralization while the second ... | PMC9889428 | ||
Results | PMC9889428 | |||
Demographic data
| PMC9889428 | |||
Quantitative assessment of the remineralizing process using DIAGNOpen | PMC9889428 | |||
Effect of time | PMC9889428 | |||
Group B (biomimetic self-assembling peptides): | There was a statistically significant difference between T0, T1, and T2 groups where | PMC9889428 | ||
Effect of groups | PMC9889428 | |||
Baseline assessment before applying the remineralizing agents (T0) | GROUP B | There was no statistically significant difference between Group A (fluoride varnish) and Group B (self-assembling peptides) where | PMC9889428 | |
Assessment after the usage of the remineralizing agent by 3 months (T1) | GROUP B | There was a statistically significant difference between Group A (fluoride varnish) and Group B (self-assembling peptides) where | PMC9889428 | |
Assessment after the usage of the remineralizing agent by 6 months (T2) | GROUP B | There was a statistically significant difference between Group A (fluoride varnish) and Group B (self-assembling peptides) where | PMC9889428 | |
Qualitative assessment of the remineralizing process using ICDAS scoring system | The frequencies of ICDAS along with different time intervals of different groups are shown in Table The frequencies of ICDAS along with different time intervals of different groups | PMC9889428 | ||
Effect of time | PMC9889428 | |||
Group A (fluoride varnish with tricalcium phosphate) | There was a statistically significant difference between T0 (baseline assessment before applying any remineralizing agent), T1 (after applying the remineralizing agents by 3 months), and T2 (after applying the remineralizing agents after 6 months) groups where | PMC9889428 | ||
Group B (biomimetic self-assembling peptides) | There was a statistically significant difference between T0 (baseline assessment before applying any remineralizing agent), T1 (after applying the remineralizing agents by 3 months), and T2 (after applying the remineralizing agents after 6 months) groups where | PMC9889428 | ||
Effect of groups | PMC9889428 | |||
Baseline assessment before applying the remineralizing agents (T0) | GROUP B | There was no statistically significant difference between Group A and Group B groups where | PMC9889428 | |
Assessment after usage of the remineralizing agent by 3 months (T1) | GROUP B | There was no statistically significant difference between Group A and Group B groups where | PMC9889428 | |
Assessment after usage of the remineralizing agent by 6 months (T2) | GROUP B | There was no statistically significant difference between Group A and Group B groups where | PMC9889428 | |
Correlation between the quantitative and qualitative analysis of the remineralizing process using DIAGNOdent pen and ICDAS: | As presented in Table Correlation between remineralizing process using DIAGNOpen and ICDAS | PMC9889428 | ||
Representative photos illustrating the qualitative analysis using ICDAS | incisors | A preoperative photo shows a post-orthodontics white spot lesion spread along the surface of the left central incisors. It appeared as a line around the orthodontic bracket in the right central incisors. Both are located mainly in the cervical third of the labial surface of the incisors. The same description applies to... | PMC9889428 | |
Discussion | carious lesions, carious lesion, caries, caries lesion, Tooth enamel, carious enamel lesion, tooth | DENTAL CARIES, DEMINERALIZATION, GROUP B, DENTAL PLAQUE, CARIES, PLAQUE, HYDROXYAPATITE | Orthodontic therapy with fixed appliances may lead to a rapid increase in the volume of dental plaque with an elevated level of acidogenic bacteria. The low pH of dental plaque and subsequent imbalance of the remineralization-demineralization equilibrium favor demineralization in areas where optimum oral hygiene become... | PMC9889428 |
Conclusions | REGRESSION | Within the limitation of the present study, biomimetic remineralization promoted by self-assembling peptides has achieved successful subsurface remineralization making the material a promising guide to lesion regression in post-orthodontic therapy. | PMC9889428 | |
Recommendations | carious lesions, cavitated lesions | FOUNDER, DENTIN HYPERSENSITIVITY |
Clinical trials with further long-term follow-up studies are recommended.Further investigations are needed to assess self-assembling peptides on advanced and cavitated lesions.The material’s efficacy in the management of dentin hypersensitivity needs to be investigated.Investigating the material as a founder to the re... | PMC9889428 |
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC9889428 | ||
Declarations | PMC9889428 | |||
Ethics approval | The protocol of the current study was registered on clinical trials with a unique identification number (I.D. NCT03930927). Ethical approval was obtained before the start of the study. The study was approved by the Research Ethics Committee (CREC), Faculty of Dentistry with an ethical approval number (19754). | PMC9889428 | ||
Informed consent | Informed consent with an easy Arabic language was signed by the recruited participants. | PMC9889428 | ||
Conflict of interest | The authors declare no competing interests. | PMC9889428 | ||
References | PMC9889428 | |||
Key Points | PMC10600583 | |||
Question | BREAST CANCER | Are there racial and ethnic disparities in survival among participants enrolled in clinical trials receiving standardized initial care for early-stage breast cancer? | PMC10600583 | |
Findings | tumor | TUMOR | In this cohort study with 9479 participants, pooled survival data suggest that survival differences exist even within clinical trial participants receiving similar initial care. Subgroups, defined by tumor subtype, age, and/or body mass index, that may drive racial and ethnic disparities in survival were identified. | PMC10600583 |
Meaning | tumor, breast cancer | TUMOR, BREAST CANCER | These findings suggest potential factors contributing to racial and ethnic disparities in survival of patients with breast cancer; it is critical to evaluate interventions for improvement.This cohort study assesses the association of race and ethnicity with survival among clinical trial participants with early-stage br... | PMC10600583 |
Importance | tumor, breast cancer | TUMOR, BREAST CANCER | Black women in the United States have higher breast cancer (BC) mortality rates than White women. The combined role of multiple factors, including body mass index (BMI), age, and tumor subtype, remains unclear. | PMC10600583 |
Objective | tumor | TUMOR | To assess the association of race and ethnicity with survival among clinical trial participants with early-stage BC (eBC) according to tumor subtype, age, and BMI. | PMC10600583 |
Design, Setting, and Participants | 49907, Leukemia, Cancer | ONCOLOGY, GROUP B, LEUKEMIA, CANCER | This cohort study analyzed survival data, as of November 12, 2021, from participants enrolled between 1997 and 2010 in 4 randomized adjuvant chemotherapy trials: Cancer and Leukemia Group B (CALGB) 9741, 49907, and 40101 as well as North Central Cancer Treatment Group (NCCTG) N9831, legacy groups of the Alliance of Cli... | PMC10600583 |
Exposures | Non-Hispanic Black and Hispanic participants were compared with non-Hispanic White participants within subgroups of subtype (hormone receptor positive [HR+]/ | PMC10600583 | ||
Main Outcomes and Measures | Recurrence-free survival (RFS) and overall survival (OS). | PMC10600583 | ||
Results | Of 9479 participants, 436 (4.4%) were Hispanic, 871 (8.8%) non-Hispanic Black, and 7889 (79.5%) non-Hispanic White. The median (range) age was 52 (19.0-89.7) years. Among participants with HR+/ | PMC10600583 | ||
Conclusions and Relevance | In this cohort study, racial and ethnic survival disparities were identified in patients with eBC receiving standardized initial care, and potentially at-risk subgroups, for whom focused interventions may improve outcomes, were found. | PMC10600583 | ||
Introduction | cancer, breast cancer | CANCER, BREAST CANCER | For several decades, non-Hispanic Black women have had substantially higher breast cancer (BC) mortality rates than non-Hispanic White women.A previous pooled analysis of SWOG clinical trials showed that, while no racial disparities were observed for most cancer types, non-Hispanic Black women with BC were more likely ... | PMC10600583 |
Methods | PMC10600583 | |||
Data and Patients | Leukemia, Cancer | GROUP B, LEUKEMIA, CANCER | We included participants enrolled in 4 adjuvant chemotherapy trials: Cancer and Leukemia Group B (CALGB) C9741 ( | PMC10600583 |
Flow Diagram of Participants | Leukemia, Cancer | GROUP B, LEUKEMIA, CANCER | CALGB indicates Cancer and Leukemia Group B; NCCTG, North Central Cancer Treatment Group. | PMC10600583 |
Measures and Outcomes | death, Tumor | EVENTS, RECURRENCE, TUMOR | Tumor hormone receptor (HR) and RFS events included local, regional, or distant BC recurrence or death due to any cause. | PMC10600583 |
Statistical Analysis | Median follow-up was estimated using the reverse Kaplan-Meier method. | PMC10600583 | ||
Results | PMC10600583 | |||
Patient Characteristics | Of 10 011 women enrolled in the included trials, 9479 (94.7%) had available survival and race and ethnicity data and were included in this pooled analysis. Their median (IQR) follow-up time was 9.8 (6.7-13.2) years, and 435 participants (4.6%) were designated as lost to follow-up. All participants were female. There we... | PMC10600583 | ||
Participant Baseline Characteristics | obesity, Leukemia, Cancer | OBESITY, GROUP B, LEUKEMIA, DISEASE, CANCER | Abbreviations: −, negative; +, positive; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CALGB, Cancer and Leukemia Group B; HR, hormone receptor; NCCTG, North Central Cancer Treatment Group.Other race and ethnicity includes American Indian or Alaska Native, Asian, Native H... | PMC10600583 |
Survival and Race and Ethnicity | PMC10600583 | |||
Survival Within Tumor Subtypes by Race and Ethnicity | tumor | TUMOR | We evaluated differences in RFS and OS among racial and ethnic groups for participants with the same BC subtype. Of all 9479 participants, 8588 (90.6%) had available tumor subtype data and were included in these analyses. Global tests for the association of the race and ethnicity variable with tumor subtype were not st... | PMC10600583 |
Forest Plots of Hazard Ratios Comparing Survival in Tumor Subtype by Race/Ethnicity | − Indicates negative; +, positive; HR, hormone receptor; OS, overall survival; and RFS, recurrence-free survival. | PMC10600583 | ||
Survival Within Age Categories by Race and Ethnicity | We next evaluated survival differences within age groups. All 9479 participants had available age data and were included in these analyses. Within the middle age group, ages 50 to younger than 65 years, race and ethnicity were associated with RFS (global | PMC10600583 | ||
Forest Plots of Hazard Ratios Comparing Survival in Age Category by Race/Ethnicity | OS indicates overall survival; RFS, recurrence-free survival.When further analyzed within subgroups jointly defined by subtype and age, race and ethnicity were associated with RFS in older participants with HR+/ | PMC10600583 | ||
Survival Within BMI Categories by Race and Ethnicity | obesity | OBESITY | We also studied survival differences between race and ethnicity groups within BMI categories. Of all 9479 participants, 9352 (98.7%) had available BMI data and were included in these analyses. For participants with underweight and obesity, race and ethnicity were not significantly associated with RFS or OS on global te... | PMC10600583 |
Forest Plots of Hazard Ratios Comparing Survival in Body Mass Index Category by Race/Ethnicity | obesity | OBESITY, DISEASE | Body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) groups were determined based on Center for Disease Control and Prevention definitions of underweight, healthy weight, overweight, and obesity as follows less than 18.5, 18.5 to less than 25.0, 25.0 to less than 30.0, and 30.0 o... | PMC10600583 |
Discussion | obesity, Obesity, Breast Cancer, tumor, HR+ BC, overweight, Cancer | OBESITY, OBESITY, TUMOR, BREAST CANCER, DISEASE, CANCER | We identified disease and patient subgroups with similarities and differences in survival among racial and ethnic groups for participants enrolled in 4 Alliance adjuvant chemotherapy clinical trials for eBC. While race and ethnicity, in general, were not associated with survival when stratified by subtype, non-Hispanic... | PMC10600583 |
Limitations | tumor, death | TUMOR | This study has limitations. Despite the pooled nature of this analysis, there are small sample sizes within certain strata. For example, small numbers of very young patients precluded our ability to specifically study women under the age of 40 years, a group that has been shown to exhibit differences in tumor genomics ... | PMC10600583 |
Conclusions | tumor | TUMOR | In this cohort study of clinical trial participants treated for eBC, we observed worse survival among Black or Hispanic participants within subgroups defined by age, BMI, or tumor subtype. These data suggest that, in addition to addressing the social and structural factors that contribute to racial and ethnic dispariti... | PMC10600583 |
Abstract | PMC10652308 | |||
Background | PDAC | PANCREATIC DUCTAL ADENOCARCINOMA | Pancreatic ductal adenocarcinomas (PDAC) are characterized by frequent cell cycle pathways aberrations. This study evaluated safety and efficacy of abemaciclib, a cyclin‐dependent kinase 4 and 6 inhibitor, as monotherapy or in combination with PI3K/mTOR dual inhibitor LY3023414 or TGFβ inhibitor galunisertib versus sta... | PMC10652308 |
Methods | PDAC | DISEASE | This Phase 2 open‐label study enrolled patients with metastatic PDAC who progressed after 1–2 prior therapies. Patients were enrolled in a safety lead‐in (abemaciclib plus galunisertib) followed by a 2‐stage randomized design. Stage 1 randomization was planned 1:1:1:1 for abemaciclib, abemaciclib plus LY3023414, abemac... | PMC10652308 |
Results | One hundred and six patients were enrolled. Abemaciclib plus galunisertib did not advance to Stage 1 for reasons unrelated to safety or efficacy. Stage 1 DCR was 15.2% with abemaciclib monotherapy, 12.1% with abemaciclib plus LY3023414, and 36.4% with SOC. Median PFS was 1.7 months (95% CI: 1.4–1.8), 1.8 months (95% CI... | PMC10652308 | ||
Conclusion | PDAC.Pancreatic ductal adenocarcinomas, PDAC | DISEASE | In patients with pretreated metastatic PDAC, abemaciclib‐based therapy did not improve DCRs or PFS compared with SOC chemotherapy. No treatment arms advanced to Stage 2. Abemaciclib remains investigational in patients with PDAC.Pancreatic ductal adenocarcinomas (PDAC) are characterized by frequent cell cycle pathways a... | PMC10652308 |
INTRODUCTION | cancer deaths, PDAC, Abemaciclib | PANCREATIC DUCTAL ADENOCARCINOMA | Pancreatic ductal adenocarcinoma (PDAC) is highly lethal and the fourth leading cause of cancer deaths worldwide, with a 5‐year survival of only 10%.
Preclinical data with the CDK4/6 inhibitors, palbociclib and abemaciclib, demonstrated variable single‐agent efficacy in PDAC models.Abemaciclib is a potent, selective sm... | PMC10652308 |
METHODS | PMC10652308 | |||
Study design | PDAC | DISEASE PROGRESSION | Study I3Y‐MC‐JPCJ was an international, multicenter, adaptive, randomized, open‐label, Phase 2 study in patients with metastatic PDAC who had disease progression after 1 or 2 prior therapies. The study aimed to evaluate the safety and efficacy of abemaciclib monotherapy or in combination with targeted agents versus sta... | PMC10652308 |
Patients | PDAC | DISEASE PROGRESSION, DISEASE, DIABETES MELLITUS, CENTRAL NERVOUS SYSTEM METASTASES, ONCOLOGY | Eligible patients were ≥18 years of age with metastatic PDAC and disease progression following 1 or 2 prior lines of therapy. Patients were required to have measurable disease as defined by RECIST v1.1, an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, adequate organ function, and be consi... | PMC10652308 |
Randomization and treatment | toxicity, PD, death, toxicities | DISEASE | An interactive web response system assigned treatment. Investigational treatments were administered orally with or without food on a 28‐day cycle, unless otherwise noted. Standard chemotherapy was administered according to prescribing label recommendations. Treatment was continued until progressive disease (PD), unacce... | PMC10652308 |
Safety and efficacy assessments | Cancer | ADVERSE EVENT, ADVERSE EVENT, CANCER | Adverse events (AEs) were collected and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. | PMC10652308 |
Pharmacokinetics | pre‐dose | For patients receiving abemaciclib, PK samples were collected on Cycle 1 Day 1 approximately 2 h after dosing and pre‐dosed on Day 1 of Cycles 2, 3, and 4. During the safety lead‐in, PK samples were collected pre‐dose on Cycle 1 Days 1 and 14, and at 0.5‐, 1‐, 2‐, 4‐, 6‐, and 8‐h post‐dose. Pharmacokinetics samples wer... | PMC10652308 | |
Endpoints | tumor, SD, death | DISEASE, TUMOR | Stage 1 primary endpoint was disease control rate (DCR) defined as the proportion of patients with a best tumor response of CR, PR, or SD (DCR = CR + PR + SD) in the intent‐to‐treat population. Responses and SD did not require confirmation. Secondary endpoints included ORR (CR + PR), pharmacokinetics (PK) of abemacicli... | PMC10652308 |
Statistical analyses | tumor | TUMOR | The study had a two‐stage design. During Stage 1, approximately 25 patients per arm were planned to provide a preliminary assessment of DCR and safety. The DCR of abemaciclib (Arm A) and abemaciclib plus LY3023414 (Arm B) were compared to SOC chemotherapy (Arm D). The null hypothesis assumed the DCR with SOC or abemaci... | PMC10652308 |
RESULTS | PMC10652308 | |||
Patients | fluoropyrimidine‐based | ONCOLOGY | From January 2017 to December 2017, 7 patients were treated with abemaciclib plus galunisertib (safety lead‐in), and 99 patients were randomized to receive abemaciclib (Arm A: Summary of patient disposition.Demographics and baseline characteristics (safety lead‐in and ITT population).Abbreviations: ECOG PS, Eastern Coo... | PMC10652308 |
Treatment | Median duration of abemaciclib treatment was 7.9 weeks (galunisertib safety lead‐in), 6.7 weeks (Arm A), 4.1 weeks (Arm B), 10.6, and 5.1 weeks with gemcitabine and capecitabine (Arm D), respectively. At the data cutoff, a total of 86 patients (86.9%) had discontinued study treatment. Reasons for treatment discontinuat... | PMC10652308 | ||
Efficacy | deaths, tumor | DISEASE, BEST, TUMOR | Sixty‐one of 99 patients enrolled (61.6%) were evaluable for response, and 38 patients (38.4%) did not have a post‐baseline scan and were considered non‐evaluable. Of these non‐evaluable patients, 8 (21.1%) were randomized but never treated, 21 (55.3%) died before imaging assessment, and 9 (23.7%) withdrew consent or r... | PMC10652308 |
Safety | neutropenia, fatigue, toxicity, thrombocytopenia, TEAEs | ADVERSE EVENTS, THROMBOCYTOPENIA, NEUTROPENIA | Treatment‐emergent adverse events (TEAEs) occurred in >99% of the treated patients (Treatment‐emergent adverse events occurring in ≥15% of patients (Safety Population).Abbreviations: Grade 4 neutropenia in 1 (14.3%) patient.Grade 4 thrombocytopenia in 1 (3.1%) patient.Grade 4 thrombocytopenia in 3 (9.1%) patients.Grade... | PMC10652308 |
Pharmacokinetics | The PK parameters for abemaciclib and galunisertib in the safety lead‐in arm and for abemaciclib plus LY3023414 in Arm B were consistent with the PKs observed in single agent studies (Table Similarly, steady‐state exposures for abemaciclib, its metabolites, galunisertib, and LY3023414 (Figure | PMC10652308 | ||
DISCUSSION | nausea, fatigue, diarrhea, toxicity, toxicities, gastrointestinal AEs, PDAC, anemia | ADVERSE EVENTS, ADVANCED CANCER, CANCER PROGRESSION, ANEMIA |
Following a safety lead‐in of abemaciclib plus galunisertib, testing of this combination was stopped by the sponsor for reasons unrelated to safety, and it did not advance to Stage 1. In Stage 1, no abemaciclib‐containing arms demonstrated DCRs superior to SOC chemotherapy in the ITT population (15.2% and 12.1% vs. 36... | PMC10652308 |
LIMITATIONS | PDAC | DISEASE | Patients with metastatic PDAC have rapidly progressive disease, and few clinical trials, especially in the absence of a chemotherapy backbone, have demonstrated clinical benefit for patients with such advanced disease and an absence of targetable molecular alterations. | PMC10652308 |
CONCLUSION | PDAC | Abemaciclib monotherapy or in combination with the PI3K/mTOR inhibitor LY3023414 did not improve DCR, PFS, or OS compared to standard chemotherapy in pretreated metastatic PDAC.Given the aggressive nature of metastatic PDAC, molecularly guided interventions will need to account for complex signaling pathways and select... | PMC10652308 | |
AUTHOR CONTRIBUTIONS | PMC10652308 | |||
FUNDING INFORMATION | The work was supported by Eli Lilly and Company (Indianapolis, IN, USA). Eli Lilly and Company had a role in the study design, collection, analysis, and interpretation of the data, writing of the manuscript, and submission of the manuscript for publication. | PMC10652308 | ||
CONFLICT OF INTEREST STATEMENT | Cancer, Novocure | CANCER | E. Gabriela Chiorean reports personal fees from AstraZeneca, Bayer, Celgene, Eisai, Ipsen, Legend, Merck, Novartis, Noxxon, Pfizer, Seattle Genetics, Sobi, and Stemline, and grants from Boehringer–Ingelheim, Bristol–Myers Squibb, Celgene, Clovis, Corcept, Fibrogen, Halozyme, Incyte, Lonza, Lilly, MacroGenics, Merck, Ra... | PMC10652308 |
ETHICS STATEMENT | The study was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments, the International Conference on Harmonization Guidelines for Good Clinical Practice, and applicable local regulations. It was approved by the ethics committees of participating centers. | PMC10652308 | ||
PATIENT CONSENT STATEMENT | All patients provided written informed consent prior to participation in the study. | PMC10652308 | ||
Supporting information | APPENDIX |
Appendix S1
Click here for additional data file. | PMC10652308 | |
ACKNOWLEDGEMENTS | The authors are grateful to the patients, their families, and caregivers for participating in this study. The authors thank the study investigators and site staff for their participation. The authors would like to acknowledge Dr. Howard Burris for reviewing the protocol. Writing and editorial support were provided by N... | PMC10652308 | ||
DATA AVAILABILITY STATEMENT | Eli Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever... | PMC10652308 | ||
REFERENCES | PMC10652308 | |||
Background | COMPLICATIONS | Many training curricula were introduced to deal with the challenges that minimally invasive surgery (MIS) presents to the surgeon. Situational awareness (SA) is the ability to process information effectively. It depends on general cognitive abilities and can be divided into three steps: perceiving cues, linking cues to... | PMC10234874 | |
Methods | This is a prospective, randomized, controlled study conducted at the MIS Training Center of Heidelberg University Hospital. Video sessions showing the steps of the laparoscopic cholecystectomy (LC) were used for cognitive training. The intervention group trained SA with interposed questions inserted into the video clip... | PMC10234874 | ||
Results | 72 participants were enrolled of which 61 were included in the statistical analysis. The SA-group performed LC significantly better (OSATS-Score SA: 67.0 ± 11.5 versus control: 59.1 ± 14.0, | PMC10234874 |
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