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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Author Contributions | Conceptualization, A.J.D., J.C.A., I.R. and M.B.; methodology, M.A.R., J.D., F.J.O., C.C.-R. and M.R.-R.M.; software, M.J.B., N.G.-G., E.S.-S. and C.C.-R.; validation A.J.D., J.C.A. and I.R.; formal analysis, M.J.B., N.G.-G. and E.S.-S.; resources, A.J.D., J.C.A., I.R. and J.D.; data curation, M.J.B., N.G.-G., M.B., J.... | PMC10648681 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki (2013), and approved by the Institutional Ethics Committee of Cádiz (protocol code 0159-N-20 02-25-2020). | PMC10648681 | ||
Informed Consent Statement | Informed consent was obtained from all patients involved in the study. | PMC10648681 | ||
Data Availability Statement | The data are collected in a database prepared by the research team. | PMC10648681 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10648681 | ||
References | fatigue, chronic illness, muscle damage, psoriatic, psoriasis | CHRONIC ILLNESS, PSORIASIS | Baseline characteristics of psoriatic patients in the intervention and control groups.Note: Results were expressed as mean (SD). PASI: psoriasis area severity index score BMI: body mass index expressed as kg/mSerum lipid profile, glycemia, and markers of muscle damage at baseline (pre intervention) and at the end of th... | PMC10648681 |
ABSTRACT | PMC10487390 | |||
Introduction | BRAIN METASTASES, METASTATIC BREAST CANCER | Around 25% of metastatic breast cancer (mBC) patients develop brain metastases, which vastly affects their overall survival and quality of life. According to the current clinical guidelines, regular magnetic resonance imaging screening is not recommended unless patients have recognized central nervous system–related sy... | PMC10487390 | |
Patient Presentation | cancer, fatigue | BRAIN METASTASES, CANCER | The patient participated in the EFFECT study, a randomized controlled trial aimed to assess the effects of a 9-month structured, individualized and supervised exercise intervention on quality of life, fatigue and other cancer and treatment-related side effects in patients with mBC. She attended the training sessions re... | PMC10487390 |
Conclusion and clinical implications | cancer | BRAIN METASTASES, CANCER | The brain metastases of this patient were detected earlier due to the recognition of subtle symptoms detected by her exercise trainer and the trust and rapid action by the clinician. The implementation of physical exercise programs for cancer patients requires well-trained professionals who know how to recognize possib... | PMC10487390 |
Key Words | seizures, breast cancer, vomiting, nausea,, headache | ONCOLOGY, BRAIN METASTASES, METASTATIC BREAST CANCER, BREAST CANCER | The incidence of brain metastases (BM) from breast cancer has increased in recent decades due to improved survival rates for metastatic breast cancer (mBC) and advances in neuroimaging leading to earlier detection (According to the American Society of Clinical Oncology and the European Society for Medical Oncology, reg... | PMC10487390 |
CASE REPORT | cancer, comorbidity, infratentorial lesion, primary breast cancer | BRAIN METASTASIS, HYPERCHOLESTEROLEMIA, CANCER, DISEASE, ONCOLOGY | A 75-yr-old woman with a diagnosis of mBC (ER+, PR-, HER2-; Ki-67 10%) participated in the EFFECT study (The woman was diagnosed with primary breast cancer in 2014, which had disseminated to the liver in 2016, to the bone in 2017 and to lymph nodes and the kidney in 2020. She had undergone chemotherapy, radiotherapy to... | PMC10487390 |
DISCUSSION | cancer, nausea, seizures | CANCER, RARE HEADACHE | This is a case report of a patient with mBC whose BM were detected early as a result of her participation in a supervised exercise program. For this to happen, three aspects were crucial: (i) the close monitoring of the patient by an experienced exercise trainer, (ii) the established communication pathways between the ... | PMC10487390 |
PRIMARY TAKE AWAY LESSONS OF THIS CASE REPORT | gait disturbance, forceful | ONCOLOGY, DISEASE PROGRESSION | Close monitoring performed by qualified exercise trainers during supervised exercise sessions can lead to the detection of subtle but significant signs of disease progression that may not be recognized yet by clinicians, patients or their family. Early detection of disease progression can make a significant difference ... | PMC10487390 |
REFERENCES | PMC10487390 | |||
Introduction | The learning curve in minimally invasive surgery (MIS) is steep compared to open surgery. One of the reasons is that training in the operating room in MIS is mainly limited to verbal instructions. The iSurgeon telestration device with augmented reality (AR) enables visual instructions, guidance, and feedback during MIS... | PMC10520207 | ||
Methods | COMPLICATIONS | Forty medical students were randomized into the iSurgeon and the control group. The iSurgeon group performed 10 LCs receiving interactive visual guidance. The control group performed 10 LCs receiving conventional verbal guidance. The performance assessment using Objective Structured Assessments of Technical Skills (OSA... | PMC10520207 | |
Results | The iSurgeon group performed LCs significantly better (global GOALS 17.3 ± 2.6 vs. 16 ± 2.6, | PMC10520207 | ||
Conclusion | COMPLICATION | Visual guidance using the telestration device with AR, iSurgeon, improves performance and lowers the complication rates in LCs in novices compared to conventional verbal expert guidance. | PMC10520207 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00464-023-10360-y. | PMC10520207 | ||
Keywords | STERILITY | Open Access funding enabled and organized by Projekt DEAL.Minimally invasive surgery (MIS) has brought significant benefits to patients undergoing surgical treatment [On the contrary to open surgery, the MIS learning curve is often hindered by the fact that instructions can only be given verbally due to distance, ergon... | PMC10520207 | |
Materials and methods | PMC10520207 | |||
Study design and participants | hand gestures | This study was designed as a randomized, controlled two-arm study. The total sample size was 40 trainees. The study was performed as a part of the complementary MIS training curriculum for medical students (trainees) in their clinical years (3rd to 6th year) at Heidelberg University Medical School, Germany. The trainin... | PMC10520207 | |
Materials | fenestrated gall bladder | COMPLICATIONS | The study was performed on a Szabo–Berci–Sackier Box Trainer and a standard laparoscopy tower (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany). A study-specific task station was specifically constructed for this study. The iSurgeon was developed at the Department of General, Visceral, and Transplantation Surgery at Heid... | PMC10520207 |
The iSurgeon | The iSurgeon is a collaborative telestration device with AR that enables interactive visual guidance during MIS procedures. With a specifically designed camera, the iSurgeon captures the tutor’s hand above the surgical field and projecting it on the operating screen. It allows tutors to draw, annotate, and provide the ... | PMC10520207 | ||
Laparoscopic cholecystectomy on an ex vivo porcine liver | fibrous, bile duct injury, Fibrous, luxation | After inserting the instruments and identifying critical anatomical structures, the gallbladder's neck was grasped with consequent luxation and identification of Calot's triangle (trigonum cholecystohepaticum) [The next step was the preparation of Calot's triangle blunt or with diathermy. Fibrous tissue strands could b... | PMC10520207 | |
Outcome parameters | injury of the gallbladder, gallbladder perforation | LIVER DAMAGE, COMPLICATION, COMPLICATIONS, COMPLICATIONS | The primary outcome of the study was performance scores assessed using standardized Objective Structured Assessments of Technical Skills (OSATS) (task-specific and global) and Global Operative Assessment of Laparoscopic Skills (GOALS) (task-specific and global) scores for all LCs performed. Global and task-specific OSA... | PMC10520207 |
Statistical analysis | REGRESSION | Statistical analysis and descriptive statistics were performed using the SPSS software (version 25.0, IBM SPSS Inc., Chicago, Illinois, USA), and data are given as absolute frequency and mean ± standard deviation. Differences between the LC were assessed using the t-test for independent samples in parametric data and t... | PMC10520207 | |
Secondary endpoints | major damage | SECONDARY | The secondary endpoints are presented in Table On the left: CVS achievement compared between the two groups. On the right: comparison of the LC’s successful completion within the 90 min time limit and without major damage to crucial anatomical structures | PMC10520207 |
Discussion | INTRAOPERATIVE COMPLICATIONS, COMPLICATION, COMPLICATIONS | Efficient training is still a challenge in the field of MIS. Several studies showed that telestration with AR showed great potential for improving surgical performance at the beginning of MIS training [There are several telestration devices with AR that have been developed to assist with surgical training and performan... | PMC10520207 | |
Limitations | STERILE | Due to the nature of the study and the spatial and temporal conditions, trainees from the iSurgeon and control group occasionally worked together in the same room. Thus, the flow of information between the two groups could have been a potential bias in both directions and within the two groups. Furthermore, since the t... | PMC10520207 | |
Conclusion | verbal and visual guidance completed more LCs | COMPLICATIONS | MIS training with the iSurgeon telestration system with AR showed better task-specific and overall MIS performance for the first ten repeated ex vivo LCs. Trainees with verbal and visual guidance completed more LCs within the time limit and performed fewer complications despite higher difficulty levels of the LCs compa... | PMC10520207 |
Acknowledgements | The authors would like to thank the medical students at the University Heidelberg for showing remarkable interest and motivation to participate and contribute to this study. | PMC10520207 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. No funding to disclose. | PMC10520207 | ||
Declarations | PMC10520207 | |||
Disclosures | P. | Amila Cizmic, Felix Müller, Philipp Anthony Wise, Frida Häberle, Felix Gabel, Karl-Friedrich Kowalewski, Vasile Bintintan, Beat P. Müller-Stich, and Felix Nickel have no conflicts of interest or financial ties to disclose. | PMC10520207 | |
References | PMC10520207 | |||
Objective | maltreatment, anhedonia | Childhood maltreatment is a potent enviromarker of risk for poor response to antidepressant medication (ADM). However, childhood maltreatment is a heterogeneous construct that includes distinct exposures that have distinct neurobiological and psychological correlates. The purpose of the current study is to examine the ... | PMC10411366 | |
Methods | depression | In a multicentre clinical trial of major depression, 164 individuals were assessed for childhood emotional, physical, and sexual maltreatment with a contextual interview with independent, standardized ratings. All individuals received 8 weeks of escitalopram, with nonresponders subsequently also receiving augmentation ... | PMC10411366 | |
Results | REMISSION | Greater severity of emotional maltreatment perpetrated by the mother was a significant and direct predictor of lower odds of week 16 remission (odds ratio [OR] = 1.68, | PMC10411366 | |
Conclusions | anhedonia | We identify emotional maltreatment as a specific early exposure that places patients at the greatest risk for nonremission following pharmacological treatment. Further, we suggest that anhedonia is a key symptom domain driving nonremission in patients with particular maltreatment histories. | PMC10411366 | |
Résumé | PMC10411366 | |||
Objectif | Les mauvais traitements dans l’enfance sont un puissant marqueur environnemental du risque d’une mauvaise réponse aux médicaments antidépresseurs (MAD). Toutefois, les mauvais traitements dans l’enfance sont une construction hétérogène qui inclut des expositions distinctes ayant des corrélats neurobiologiques et psycho... | PMC10411366 | ||
Méthodes | Dans un essai clinique multicentrique de la dépression majeure, 164 personnes ont été évaluées relativement aux mauvais traitements émotionnels, physiques et sexuels dans l’enfance et ont répondu à une entrevue contextuelle avec des notations indépendantes, standardisées. Toutes les personnes ont reçu 8 semaines d’esci... | PMC10411366 | ||
Résultats | Les mauvais traitements émotionnels plus graves perpétrés par la mère étaient un prédicteur significatif et direct de probabilités plus faibles d’une rémission à 16 semaines (RC = 1,68, | PMC10411366 | ||
Conclusions | Nous identifions les mauvais traitements émotionnels comme étant une exposition précoce spécifique qui place les patients à risque accru de non-rémission par suite d’un traitement pharmacologique. En outre, nous suggérons que l’anhédonie est un domaine de symptômes principal entraînant la non-rémission chez les patient... | PMC10411366 | ||
Introduction | maltreatment, anhedonia, sexual abuse, ARI, depressive disorder, MDD, depression, Depression, disability | REMISSION, SYNDROME | Major depressive disorder (MDD) affects close to 300 million people globally and is the leading worldwide cause of disability.Childhood maltreatment, including a history of emotional, physical, and/or sexual abuse, represents a particularly promising marker. Childhood maltreatment is the strongest developmental risk fa... | PMC10411366 |
Methods | PMC10411366 | |||
Participants | MDD, DSM-IV-TR, anhedonia | SECONDARY, DISORDERS | The current study involved a secondary analysis of 164 outpatients in a current episode of MDD who completed assessments of childhood maltreatment and anhedonia during the 6-site CAN-BIND-1 trial (ClinicalTrials.gov identifier: NCT01655706).Inclusion criteria were as follows: (1) 18–60 years old, (2) Diagnostic and Sta... | PMC10411366 |
Data Analysis | ARI, anhedonia | REGRESSION, REMISSION | SPSS statistical software version 26.0 was used for all analyses. Preliminary univariate analyses identified potential demographic or clinical covariates to include in our final models. Our first research question (maltreatment predicts remission status) was tested with a logistic regression model. The dependent variab... | PMC10411366 |
Childhood Maltreatment and Week 8 Response | ARI | REGRESSION | A multivariate logistic regression model predicting need for ARI augmentation at week 8 (i.e., week 8 response) from severity of emotional, physical, and sexual maltreatment, entered as a block, was not significant, χ | PMC10411366 |
Childhood Maltreatment, Week 8 Anhedonia, and Week 16 Remission | anhedonia | REMISSION | However, lower scores on the week 8 DARS residual (i.e., less change from baseline, and thus, greater severity of week 8 anhedonia) were significantly correlated with greater severity of emotional maltreatment, Greater severity of (a) emotional maltreatment and (b) physical maltreatment predicted less change in anhedon... | PMC10411366 |
Discussion | anhedonia, ARI, treatment-refractory, MDD, depression, depressive recall | EVENTS, MALTREATMENT, REMISSION | In a large multicentre trial that included rigorous contextual assessment of childhood maltreatment history, we found that greater severity of mother-perpetrated emotional maltreatment directly predicted lower odds of remission following 16 weeks of treatment with ESC or ESC + ARI. Further, emotional maltreatment perpe... | PMC10411366 |
References | PMC10411366 | |||
Objectives | T2DM, Diabetes | TYPE 2 DIABETES MELLITUS, DIABETES | Edited by: Yan Shu, University of Maryland, United StatesReviewed by: Haoyan Chen, Shanghai Jiao Tong University, China; Jian Zhou, Shanghai Jiao Tong University, China; Yuqian Bao, Shanghai Jiao Tong University, China†These authors have contributed equally to this workThis article was submitted to Systems Endocrinolog... | PMC9982119 |
Methods | T2DM | 77 patients with IGT in the PPDP trial were randomized to either probiotic or placebo. After the completion of the trial, 39 non-T2DM patients were invited to follow up glucose metabolism after the next 4 years. The incidence of T2DM in each group was assessed using Kaplan-Meier analysis. The 16S rDNA sequencing techno... | PMC9982119 | |
Results | T2DM | The cumulative incidence of T2DM was 59.1% with probiotic treatment versus 54.5% with placebo within 6 years, there was no significant difference in the risk of developing T2DM between the two groups ( | PMC9982119 | |
Conclusions | T2DM | Supplemental probiotic therapy does not reduce the risk of IGT conversion to T2DM. | PMC9982119 | |
Clinical Trial Registration | PMC9982119 | |||
Introduction | T2DM, prediabetes | IMPAIRED GLUCOSE TOLERANCE, TYPE 2 DIABETES MELLITUS, PREDIABETES | Compared with normal glucose tolerance (NGT), people with prediabetes, especially impaired glucose tolerance (IGT), have a higher risk of developing type 2 diabetes mellitus (T2DM). Early intervention can significantly reduce the probability of developing T2DM in the IGT population (After the PPDP trial was completed, ... | PMC9982119 |
Research design and methods | PMC9982119 | |||
PPDP study | T2DM | SECONDARY | The design and primary results of the PPDP study have been reported previously (Feces of the two groups before and after intervention were collected. The 16S rDNA sequencing technology was used to analyze intestinal microbiota’s structural composition and abundance changes. The primary outcome was the cumulative preval... | PMC9982119 |
PPDP follow-on study | T2DM, blood tumor | After the completion of the initial PPDP study, patients who with undiagnosed T2DM continue to be invited to participate in the PPDP Follow-On study without probiotics intervention. A total of 39 non-T2DM patients agreed to follow up glucose metabolism for next 4 years. Patients were asked to monitor fasting and postpr... | PMC9982119 | |
16S rRNA gene sequencing and analysis | Fresh fecal samples were collected and bacteria’s 16S rRNA gene sequence was detected using paired-end configuration on an Illumina MiSeq system (Illumina, San Diego, USA). Briefly, microbial DNA was extracted and DNA quality was examined by agarose gel electrophoresis. The V3-V4 regions of the bacteria’s 16S rRNA gene... | PMC9982119 | ||
Statistical analyses | Statistical analyses were performed by SPSS version 23.0 (IBM Corp, Armonk, NY, USA) and GraphPad Prism version 8.0 (San Diego, California, USA). Continuous data were described as means ± standard deviation, and inter-group comparison was performed with a t-test or analysis of variance. All continuous data were abnorma... | PMC9982119 | ||
Results | PMC9982119 | |||
Baseline characteristics | T2DM | INSULIN RESISTANCE | The baseline characteristics of the Probiotics group and Placebo group in the PPDP study have been presented in the previous article (9). Specifically, there were no significant differences in sex composition, age, body mass index (BMI), blood pressure, heart rate, liver function, blood lipid profile, FPG, post-glucose... | PMC9982119 |
Comparison of the incidence of T2DM | T2DM | In the next 4 years, there were 6 patients in the Probiotics group and 5 patients in the Placebo group who developed T2DM. Thus, the cumulative incidence of T2DM was 59.1% in the probiotic group and 54.5% in the placebo group within 6 years. As shown in Kaplan-Meier analysis of the cumulative incidence of T2DM within 6... | PMC9982119 | |
COX regression analysis of risk factors for T2DM | T2DM | REGRESSION | COX regression model was used to analyze the risk factors affecting the development of T2DM. Probiotic intervention or not, age, gender, BMI, waist circumference, blood pressure, liver function, blood lipid, blood glucose, serum insulin and HbA1c were used as covariates, and results showed that 30-minute post-glucose l... | PMC9982119 |
Gut microbiota analysis | T2DM | According to the informed consent and research protocol, fecal samples were collected at baseline (day 0) and the end of the 2-year follow-up visit. The 16S rDNA sequencing technology was used to analyze gut microbiota’s structural composition and abundance changes. A total of 32 stool samples in the Probiotic group an... | PMC9982119 | |
Discussion | obesity, gestational diabetes, metabolic diseases, metabolic disease, T2DM, diabetes | METABOLIC DISEASES, OBESITY, GESTATIONAL DIABETES, DIABETES | IGT is closely associated with metabolic disease progression. According to the epidemiological data, about 70% of IGT patients progress to DM within 5 years in China (The treatment of metabolic diseases with probiotics is a hot topic in intestinal microbiota research. However, there are fewer studies on probiotics for ... | PMC9982119 |
Conclusions | Lactobacillus acidophilus | Nevertheless, the results of this study suggest that supplementation with active probiotics of Bifidobacterium, Lactobacillus acidophilus and Enterococcus faecalis is safe, although it does not reduce the risk of IGT conversion to DM. More clinical and laboratory studies using large samples and long-term observation ar... | PMC9982119 | |
Data availability statement | The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found below: NCBI BioProject [ | PMC9982119 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the institutional review board of Shanghai East Hospital and was conducted in accordance with the Declaration of Helsinki. The patients/participants provided their written informed consent to participate in this study. | PMC9982119 | ||
Author contributions | BF designed the study and oversaw the project implementation. QY conceived and carried out experiments. WH and YT participated in data analyses, interpretation and writing publications. XUL, YY and XIL participated in data collection, data analyses and interpretation and writing publications. All authors were involved ... | PMC9982119 | ||
Acknowledgments | We were grateful to the participants and nurses in the Department of endocrinology of Shanghai East hospital for participating in this study. | PMC9982119 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9982119 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9982119 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC9982119 | ||
References | PMC9982119 | |||
Subject terms | coronavirus disease 2019 | SECONDARY, CORONAVIRUS DISEASE 2019 | Large clinical trials often generate complex and large datasets which need to be presented frequently throughout the trial for interim analysis or to inform a data safety monitory board (DSMB). In addition, reliable and traceability are required to ensure reproducibility in pharmacometric data analysis. A reproducible ... | PMC10539503 |
Introduction | coronavirus disease 2019 | CORONAVIRUS, CORONAVIRUS DISEASE 2019, SEVERE ACUTE RESPIRATORY SYNDROME | Clinical trial datasets are becoming larger and increasingly complex with innovative advances in biomarker including genomic, transcriptomic, proteomic, and metabolomic measurements, mobile or wearable patient surveillance, and the use of real-world dataPharmacometricians are experts in data review, processing, and ana... | PMC10539503 |
Methods | PMC10539503 | |||
Workflow structure | The reproducible pharmacometric workflow was designed in consensus between the pharmacometricians, clinicians, and data managers within the project, and is shown in Fig. Overview of the pharmacometric reproducibility workflow. Clinical operations were the initial start of the workflow, but because of its circularity, a... | PMC10539503 | ||
Clinical trial data | ADVERSE EVENTS, INJECTION SITE REACTION, EVENTS, RESPIRATORY TRACT INFECTION (RTI) | The clinical trial data was captured in four master databases namely Screening/enrolment, Events, Lab results, and Follow-up, which consisted of 59 datasets in total. The Screening/enrolment database contained the participant demographics, medical and social history, and trial specific information such as inclusion/exc... | PMC10539503 | |
Data review | The clinical team’s QC ensured all data entries to the eCRF platform corresponded to the paper source documentation. The data management’s QC subsequently checked the eCRF platform data on MedDRA coding, duplicates, incomplete or non-QC-ed records, etc. Once data had passed the clinical and data management QCs successf... | PMC10539503 | ||
Reporting | Frequent reporting on the progress of the trial was critical to identify early evidence of efficacy, if present. To that aim, the reports contained graphical and tabular exploration of the data without formal interim statistical testing. To limit the time between data transfer and distributing data reports, the pharmac... | PMC10539503 | ||
Pharmacometric analysis preparation | The pharmacometric processing script was also utilized for the pharmacometric analysis preparation. The integrated database that was input for the tables and graphs in the report, was transformed into the pharmacometric analysis datasets in NONMEM v.7.4.3 | PMC10539503 | ||
Results | PMC10539503 | |||
Transfer of clinical trial data | Instead of the conventional approach of receiving data for pharmacometric analysis after the trial completion, an iterative data transfer and reproducible data handling workflow was developed by consensus between the clinical, data management, and pharmacometric teams who collaborated in this clinical trial. Data QC an... | PMC10539503 | ||
Understanding and confidence in handling through data review | COVID-19 respiratory tract infections, viral syndrome | SARS-COV-2 INFECTION, ASYMPTOMATIC SARS-COV-2 INFECTION, COVID-19 PNEUMONIA, DISEASE, EVENT, COVID-19 INFECTION, POST VIRAL SYNDROME, EVENTS, VIRAL SYNDROME, EVENTS, POST VIRAL SYNDROME | The frequent interim data QC by the clinical, data management, and pharmacometric teams was a time-saving investment. All records were subject to check after entry into the eCRF, and the clinical QC and data management combined found in 20.9% of the records that a correction was needed when the eCRF was compared to the... | PMC10539503 |
Interoperability | Interoperability between members of the pharmacometric team was essential to divide the work with the short timelines. The pharmacometric processing script was stored in a private Github repository where multiple coders could work simultaneously. Through Github, changes to parts of the script by team members could be r... | PMC10539503 | ||
Automatically compiled and consistent data reports | The pharmacometric team prepared the data reports for the DSMB to review the safety and efficacy of the ongoing trial. Because of the time-sensitive nature of the vaccination trial, initially biweekly reporting was proposed, which was later amended to a lower frequency by request of the DSMB and the clinical team becau... | PMC10539503 | ||
Pharmacometric analysis preparation | RTI, SECONDARY | The pharmacometric processing script was also developed to include the pharmacometric analysis dataset creation. This resulted in a transparent, traceable, and version-controlled workflow from the raw eCRF input data to the analysis dataset in NONMEM format. Moreover, because the same script and integrated database was... | PMC10539503 | |
Discussion | SECONDARY | A reproducible pharmacometric workflow was developed here to review data iteratively during a clinical trial, report the trial data frequently to the DSMB, and prepare for the pharmacometric analyses of the primary and secondary endpoints upon trial completion to answer time-sensitive questions. Early collaboration bet... | PMC10539503 | |
Conclusion | The reproducible pharmacometric workflow we developed resulted in fast, efficient, and reliable analyses in a large clinical trial during the COVID-19 pandemic in South Africa. The constructive collaboration between clinical, data management, and pharmacometric teams enabled this efficient and robust pharmacometric dat... | PMC10539503 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-43412-3. | PMC10539503 | ||
Acknowledgements | The authors gratefully acknowledge all members of the clinical and data management teams for their hard work under short timelines and for the constructive discussions. This project was part of the EDCTP2 programme supported by the European Union (grant number RIA2020EF-2968-Re-BCG-CoV-19). The computations were enable... | PMC10539503 | ||
Author contributions | All authors conceptualized the work and designed the workflow. All authors wrote the manuscript and approved the final version. | PMC10539503 | ||
Funding | Open access funding provided by Uppsala University. | PMC10539503 |
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