Nicolás Ballarini
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View article: Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations
Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations Open
This exploratory study confirmed external comparator strengths and limitations by quantifying the impact of missing data and unmeasured confounding using case studies and simulations. In particular, missing data in key eligibility criteria…
View article: Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial
Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial Open
View article: Protocol for a Multicenter, Prospective, Observational Pilot Study on the Implementation of Resource-Stratified Algorithms for the Treatment of Severe Traumatic Brain Injury Across Four Treatment Phases: Prehospital, Emergency Department, Neurosurgery, and Intensive Care Unit
Protocol for a Multicenter, Prospective, Observational Pilot Study on the Implementation of Resource-Stratified Algorithms for the Treatment of Severe Traumatic Brain Injury Across Four Treatment Phases: Prehospital, Emergency Department, Neurosurgery, and Intensive Care Unit Open
BACKGROUND: Severe traumatic brain injury (sTBI) is a public health issue with great disparity among low- and middle-income countries where the implementation of evidence-based guidelines is challenging because resources are often unavaila…
View article: Optimizing subgroup selection in two‐stage adaptive enrichment and umbrella designs
Optimizing subgroup selection in two‐stage adaptive enrichment and umbrella designs Open
We design two‐stage confirmatory clinical trials that use adaptation to find the subgroup of patients who will benefit from a new treatment, testing for a treatment effect in each of two disjoint subgroups. Our proposal allows aspects of t…
View article: <b>subtee</b>: An <i>R</i> Package for Subgroup Treatment Effect Estimation in Clinical Trials
<b>subtee</b>: An <i>R</i> Package for Subgroup Treatment Effect Estimation in Clinical Trials Open
The investigation of subgroups is an integral part of randomized clinical trials. Exploration of treatment effect heterogeneity is typically performed by covariate-adjusted analyses including treatment-by-covariate interactions. Several st…
View article: Delayed treatment effects, treatment switching and heterogeneous patient populations: How to design and analyze<scp>RCTs</scp>in oncology
Delayed treatment effects, treatment switching and heterogeneous patient populations: How to design and analyze<span>RCTs</span>in oncology Open
SUMMARY In the analysis of survival times, the logrank test and the Cox model have been established as key tools, which do not require specific distributional assumptions. Under the assumption of proportional hazards, they are efficient an…
View article: Hypothyroidism correlates with favourable survival prognosis in patients with brain metastatic cancer
Hypothyroidism correlates with favourable survival prognosis in patients with brain metastatic cancer Open
View article: A critical review of graphics for subgroup analyses in clinical trials
A critical review of graphics for subgroup analyses in clinical trials Open
SUMMARY Subgroup analyses are a routine part of clinical trials to investigate whether treatment effects are homogeneous across the study population. Graphical approaches play a key role in subgroup analyses to visualise effect sizes of su…
View article: Single-reviewer abstract screening missed 13 percent of relevant studies: a crowd-based, randomized controlled trial
Single-reviewer abstract screening missed 13 percent of relevant studies: a crowd-based, randomized controlled trial Open
View article: Response by Andreas et al to Letter Regarding Article, “Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation”
Response by Andreas et al to Letter Regarding Article, “Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation” Open
View article: The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal
The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal Open
View article: Subgroup identification in clinical trials via the predicted individual treatment effect
Subgroup identification in clinical trials via the predicted individual treatment effect Open
Identifying subgroups of treatment responders through the different phases of clinical trials has the potential to increase success in drug development. Recent developments in subgroup analysis consider subgroups that are defined in terms …
View article: Intensive care treatments associated with favorable discharge outcomes in Argentine children with severe traumatic brain injury: For the South American Guideline Adherence Group
Intensive care treatments associated with favorable discharge outcomes in Argentine children with severe traumatic brain injury: For the South American Guideline Adherence Group Open
There is variation in Argentine ICU practice in the care of children with severe TBI. Second insults are common and hyperosmolar therapy use is uncommon. Adherence to best practice TBI care by avoiding hypoxia and providing timely nutritio…
View article: Creating Leaders: A Pilot Pre/Post Evaluation of an Ontological/Phenomenological Model
Creating Leaders: A Pilot Pre/Post Evaluation of an Ontological/Phenomenological Model Open
View article: Benchmarking Prehospital and Emergency Department Care for Argentine Children with Traumatic Brain Injury: For the South American Guideline Adherence Group
Benchmarking Prehospital and Emergency Department Care for Argentine Children with Traumatic Brain Injury: For the South American Guideline Adherence Group Open
This study benchmarks early pediatric TBI care in Argentina and shows that many critically injured children with TBI do not receive timely or best practice PH care, that PH guideline adherence rate is low and that longer transport time was…
View article: Creating Leaders: A Pilot Pre/Post Evaluation of an Ontological/Phenomenological Model
Creating Leaders: A Pilot Pre/Post Evaluation of an Ontological/Phenomenological Model Open
This pilot is a pre/post comparative assessment of a leadership course developed and delivered using an innovative, ontological/phenomenological model of education. Participants in the course delivered in Singapore in July of 2014 provided…
View article: Postdischarge Care of Pediatric Traumatic Brain Injury in Argentina: A Multicenter Randomized Controlled Trial*
Postdischarge Care of Pediatric Traumatic Brain Injury in Argentina: A Multicenter Randomized Controlled Trial* Open
Objective: To develop, in partnership with families of children with traumatic brain injury, a postdischarge intervention that is effective, simple, and sustainable. Design: Randomized Controlled Trial. Setting: Seven Level 1 Pediatric Tra…
View article: Evaluation of the Impact of Anti-Thymocyte Globulin (ATG) on Post-Hematopoietic Cell Transplant (HCT) Outcomes in Patients Undergoing Allogeneic HCT
Evaluation of the Impact of Anti-Thymocyte Globulin (ATG) on Post-Hematopoietic Cell Transplant (HCT) Outcomes in Patients Undergoing Allogeneic HCT Open
Anti-thymocyte globulin (ATG) is often incorporated into allogeneic stem cell transplant (alloHCT) conditioning regimens to prevent graft-versus-host disease (GVHD). Literature regarding the effect of ATG on outcomes is mixed; some data su…