title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Conclusion | necrosis | REMISSION, DISEASE, MEDULLOBLASTOMA, NECROSIS | For patients with medulloblastoma, remission at time of cRIT was associated with significantly improved survival outcomes. Relapses are often multifocal, particularly in the setting of measurable disease at cRIT initiation. EBRT is a promising tool to achieve NED status at cRIT initiation, with no cases of radiation ne... | PMC10050019 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s11060-022-04235-w | PMC10050019 | ||
Keywords | PMC10050019 | |||
Introduction | toxicity, necrosis | PRIMARY TUMORS, RECURRENT DISEASE, REMISSION, MEDULLOBLASTOMA, NECROSIS | Curative treatment options for patients with recurrent primary tumors of the central nervous system (CNS) are limited. Many patients have had previous multimodality therapy, including external beam radiotherapy (EBRT), which introduces the potential for toxicity with additional treatments. For instance, radiation necro... | PMC10050019 |
Materials and methods | PMC10050019 | |||
Eligible patients | medulloblastoma, ependymoma, Cancer | PRIMARY BRAIN TUMORS, MEDULLOBLASTOMA, EPENDYMOMA, CANCER | Patients with recurrent medulloblastoma or ependymoma known to express B7H3 by immunohistochemical staining were eligible to receive cRIT with 131-I-omburtamab at Memorial Sloan Kettering Cancer Center (MSK) on an IRB-approved phase I protocol (NCT# 00089245) from 2004 TO 2019. Patients were eligible for the protocol i... | PMC10050019 |
131-I-omburtamab administration | toxicity | cRIT with 131-I-Omburtamab was delivered as previously described: a test dose (2 milliCurie [mCi]/injection), then if tolerated, followed by 1 or 2 monthly injections (10-70 mCi/injection) with dosing based on a phase I dose-escalation level at the time of patient entry. Clinical status, vital signs and neurologic exam... | PMC10050019 | |
Bridging therapies | Bridging therapy was defined as treatment delivered after diagnosis of the most recent relapse prior to initiation of cRIT. Specifically, surgical resection, EBRT (focal and/or CSI), and medical therapy (both systemic and intrathecal chemo- or immunotherapies) at time of most recent relapse prior cRIT were noted. In ad... | PMC10050019 | ||
Evaluation of response | cavernomas, radionecrosis | EVENTS, RECURRENCE | All patients had conventional MRI of the brain and spine within 3 weeks prior to cRIT and approximately 5 weeks after each therapy administration along with CSF collection. MRIs included sagittal and axial T1-weighted, axial T2-weighted, axial fluid-attenuated inversion recovery (FLAIR), axial diffusion weighted images... | PMC10050019 |
Statistics | death | DISEASE, EVENT | Progression-free survival (PFS) was calculated both from time of first 131-I-omburtamab injection and from time of relapse pre-cRIT to progression, relapse, or death. Overall survival (OS) was calculated from time of first 131-I-omburtamab injection and time of pre-cRIT relapse until death. Extent of disease at cRIT in... | PMC10050019 |
Results | PMC10050019 | |||
External beam radiotherapy prior to 131-I-omburtamab | medulloblastoma, ependymoma | MEDULLOBLASTOMA, EPENDYMOMA | All patients had EBRT at a median time of 0.9 years (range 0.1–5.2) preceding cRIT (Supplemental Table 1). Most patients received CSI (22, 81%), with a median dose of 2340 cGy (range 2300–3960 cGy) with a boost to 5400 cGy (range 5040–6000 cGy). Ten (37%) CSI treatments were delivered with protons, all for patients wit... | PMC10050019 |
Disease response | PMC10050019 | |||
Medulloblastoma | medulloblastoma, ependymoma, leptomeningeal disease | RECURRENCES, DISEASE PROGRESSION, EPENDYMOMA, DISEASE, REMISSION, MEDULLOBLASTOMA, EVENTS | All 20 patients received EBRT prior to cRIT at a median time of 0.6 years (range, 0.1–4.9). Most patients (12, 60%) received EBRT as part of bridging therapy, nearly all (11, 92%) of which were re-irradiation and three were with protons (2 CSI, 1 focal; Table Swimmer’s plot demonstrating timing of treatments received a... | PMC10050019 |
Ependymoma | LMD disease, ependymoma | DISEASE, RECURRENCE, EPENDYMOMA | While all the patients with ependymoma had received EBRT at a median time of 1.2 years (range, 0.2–5.2) preceding cRIT, none had received EBRT as a bridge to cRIT after the most recent relapse (Table Five patients ultimately had progression at a median time of 0.4 years (range, 0.2–1.9) after most recent relapse and 0.... | PMC10050019 |
Radiologic events | radionecrosis, AML, infarcts, cavernoma, intramedullary hemorrhage, cerebral aqueduct stenosis, PRES | ACUTE MYELOID LEUKEMIA, INTRAMEDULLARY HEMORRHAGE, EVENT, HYDROCEPHALUS, AML, SECONDARY, SYNDROME, EFFUSIONS, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME | Of the 13 patients who had radiologic findings following cRIT, there were no cases of radionecrosis (Supplemental Table 2). The most common event identified was cavernoma (6, 46%), although all were asymptomatic and none required intervention. Three patients (23%) had hydrocephalus, one of whom was symptomatic secondar... | PMC10050019 |
Discussion | death, ependymoma, radionecrosis, toxicity, cancer, AML, medulloblastoma, necrosis, tumors | DISEASE PROGRESSION, EPENDYMOMA, DISEASE COURSE, CANCER, DISEASE, TUMORS, AML, REMISSION, MEDULLOBLASTOMA, NECROSIS, DISEASE, MINIMAL RESIDUAL DISEASE | Patients with recurrent primary CNS tumors unfortunately have few curative treatment options. Here, we demonstrate that long-term survival over two years is possible among patients with recurrent medulloblastoma or ependymoma treated with multimodality therapy at relapse. These patients comprise a heavily treated popul... | PMC10050019 |
Author contributions | OU | KRT, SLW, NKC, BEM, NPT, MS, and KK: contributed to the study design. KRT, SLW, MK, SH, NKC, BEM, MR, NPT, and KK: contributed to experimental implementation. Data analysis was performed by KRT, SLW, MK, SH, LP, OU, and KK. Data interpretation was performed by KRT, SLW, MK, SH, LP, OY, MR, JKB, NKC, MS, EMB, NPT, PBZ, ... | PMC10050019 | |
Funding | Cancer | CANCER | This work has been supported in part by the NIH/NCI Cancer Center Support Grant P30 CA008748 to Memorial Sloan Kettering Cancer Center. | PMC10050019 |
Data availability | The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10050019 | ||
Declarations | PMC10050019 | |||
Conflict of interest | Cancer | CANCER | Both Memorial Sloan Kettering Cancer Center (MSK) and Dr. Cheung have financial interest in Y-mAbs, Abpro-Labs and Eureka Therapeutics. Dr. Cheung also reports receiving commercial research grants from Y-mabs Therapeutics and Abpro-Labs Inc. Dr. Cheung was named as inventor on multiple patents filed by MSK, including n... | PMC10050019 |
References | PMC10050019 | |||
Background | infections, neutropenic, Cancer | INFECTIONS, CANCER | Multidrug-resistant Gram-negative bacterial (MRGNB) infections represent a major public health threat. Cancer patients and, among them, hematological patients are most vulnerable to these infections. Gut colonization by MRGNB is a common phenomenon occurring during hospitalization and chemotherapy exposure. In the neut... | PMC10612155 |
Methods | febrile neutropenia, acute leukemia | FEBRILE NEUTROPENIA, ACUTE LEUKEMIA | A phase III randomized, controlled, clinical trial, open-label parallel-group with a 1:1 ratio, aimed to demonstrate the non-inferiority of oral fosfomycin versus oral ciprofloxacin for febrile neutropenia prevention in patients with acute leukemia (AL) or hematopoietic cell transplant (HSC) receptors. Weekly surveilla... | PMC10612155 |
Discussion | febrile neutropenia | FEBRILE NEUTROPENIA | This trial will provide evidence of the efficacy of an alternative drug to ciprofloxacin for febrile neutropenia prevention in high-risk hematological patients. The battery of planned microbiological studies will allow us to evaluate prospectively the microbiological safety of both pharmacological strategies in terms o... | PMC10612155 |
Trial registration | Clinical trials NCT05311254, Registered on 5 April 2022, | PMC10612155 | ||
Keywords | PMC10612155 | |||
Administrative information | Martorell | DEL | Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see 1. Hematology Department, University Hospital Central of Asturias. Avenida Roma, 33011, Oviedo, Spain2. Instituto de Investigación Sanitaria del Principado de... | PMC10612155 |
Introduction | PMC10612155 | |||
Background and rationale {6a} | neutropenia, musculoskeletal and neurological adverse, dermatological infections, infection, hematologic | URINARY TRACT INFECTIONS, NEUTROPENIA, CNS INFECTIONS, INFECTION, EVENTS, GASTROINTESTINAL TRACT INFECTIONS | The use of fluoroquinolones (FQ) ciprofloxacin or levofloxacin is an established practice for the prevention of infectious events in hematologic patients in whom long lasting and profound neutropenia (absolute neutropenia count ≤ 0.1/ × 10The concerns about the increasing incidence of MRGNB and its risks have led to qu... | PMC10612155 |
Choice of comparator {6b} | febrile neutropenia | FEBRILE NEUTROPENIA | The choice of ciprofloxacin over levofloxacin is based on the evidence supporting its superiority in the prevention of febrile neutropenia [ | PMC10612155 |
Objectives {7} | PMC10612155 | |||
Hypotheses | neutropenic, fever of infectious | The use of oral fosfomycin is not inferior to oral ciprofloxacin in the prevention of fever of infectious origin in high-risk neutropenic patients. This hypothesis is based not only on the broad-spectrum activity of fosfomycin but also on the low rate of resistance to this drug. In addition, we anticipate that the clin... | PMC10612155 | |
Objective | febrile neutropenia, acute leukemia | FEBRILE NEUTROPENIA, ACUTE LEUKEMIA | The main objective of this clinical trial is to demonstrate non-inferiority in efficacy of oral fosfomycin versus oral ciprofloxacin in preventing febrile neutropenia in patients with acute leukemia treated with intensive chemotherapy and/or recipients of hematopoietic stem cell transplantation. | PMC10612155 |
Trial design {8} | DISEASE, ACUTE LEUKEMIA | The FOVOCIP study is a randomized, open-label, phase III clinical trial with a non-inferiority design, in which patients are randomized in a 1:1 ratio into two parallel, controlled prophylaxis groups: fosfomycin or ciprofloxacin. The groups are stratified by site and by underlying disease (acute leukemia or stem cell t... | PMC10612155 | |
Methods: participants, interventions, and outcomes | PMC10612155 | |||
Study setting {9} | RECRUITMENT, ACUTE LEUKEMIAS | The sponsor of this study is FINBA and plans to include 156 patients over 2 years; therefore, 11 Spanish national hospitals are needed to achieve the described objective.The hospitals included are:✓ University Hospital Central of Asturias.✓ University Hospital La Paz.✓ University Clinic Hospital San Carlos.✓ Hospital S... | PMC10612155 | |
Eligibility criteria {10} | tumor, neoplasia, psychiatric illness, Fever of infectious, infection, leukemic infiltration, mucositis, neoplasm, allogeneic hematopoietic progenitor transplant, Hematopoietic Comorbidity, acute leukemia | TUMOR, NEOPLASIA, LIVER, HYPERSENSITIVITY, INFECTION, MUCOSITIS, NEOPLASM, ONCOLOGY, ACUTE LEUKEMIA | Candidate selection will be performed in 2 different settings depending on the therapeutic procedure:In subjects with a suspected diagnosis of acute leukemia, where the diagnosis of the neoplasm is made as an inpatient, the selection will take place once the diagnosis has been confirmed and prior to the start of intens... | PMC10612155 |
Who will take informed consent? {26a} | Principal investigators in each site will provide informed consent to patient candidates for participation. The latest version approved of the patient’s information sheet will be signed by all selected subjects before inclusion in the clinical trial.In the case of selected subjects who cannot understand the study or do... | PMC10612155 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | This study complies with the current regulations of Law 14/2007 on biomedical research regarding the protection of the rights of patients who freely wish to participate and the handling of biological samples.No biological samples from patients will be stored after the end of the clinical trial. | PMC10612155 | ||
Interventions | PMC10612155 | |||
Explanation for the choice of comparators {6b} | PMC10612155 | |||
Intervention description {11a} | The description of the interventions and comparators is detailed in Table Intervention description | PMC10612155 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | EVENTS, FEBRILE NEUTROPENIA | Treatment will be interrupted when any of the following events occurs first:
Febrile neutropenia requiring antibacterial treatment (main end point of the study).Absolute neutrophil count (ANC) > 0.5 × 10If the subject fails to achieve more than 0.5 × 10Death | PMC10612155 | |
Strategies to improve adherence to interventions {11c} | Study patients will be hospitalized during the period in which they are receiving the study treatment. The investigator of each site will review and record the traceability of the medication administered. | PMC10612155 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | The concomitant medication recommendations listed in the technical data form for ciprofloxacin should be taken into consideration.Special attention should be paid to drugs that prolong the QT interval (class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, and antipsychotics) as well as tizanidine, m... | PMC10612155 | ||
Provisions for post-trial care {30} | The health professionals participating in this clinical trial belong to the Spanish National Health System. These are non-commercial studies where the sponsor is a non-profit foundation, FINBA. The trial subjects do not receive any compensation. | PMC10612155 | ||
Outcomes {12} | death, fever, febrile neutropenia, infections, infection, Fever | HAND INFECTION, FEBRILE NEUTROPENIA, ADVERSE EVENTS, INFECTIONS, MIXED INFECTION, INFECTION | The primary endpoint is febrile neutropenia requiring antibacterial treatment.Fever is defined as a single oral temperature of 38.3 °C or a temperature of 38 °C sustained over a 1-h period.If the patient is receiving any medication highly likely to induce fever or has previously received a transfusion, at least one pos... | PMC10612155 |
Microbiological assessments |
Rate of patients colonized by GNMRB as determined by surveillance and metagenomic sequencing.Changes in the gut microbiome produced in both groups. | PMC10612155 | ||
Participant timeline {13} | The flow chart for the study and the schedule visits and assessments at different points in the study protocol are described in Table Schedule of visits and assessments at different points of the study protocol
| PMC10612155 | ||
Sample size {14} | infectious fever, thirty-four | The reviewed clinical trials and meta-analyses have consistently shown that 65% of patients receiving prophylactic the fluoroquinolones levofloxacin and ciprofloxacin will develop infectious fever (2,17,18) which is consistent with success rate of 35%. Considering that the actual rate of resistance to fluoroquinolones ... | PMC10612155 | |
Recruitment {15} | acute leukemia | ACUTE LEUKEMIA | There were strategies for achieving adequate participant enrolment to reach the target sample size.Patients who are undergoing HSCT will be previously evaluated in the pre-transplant consultation while patients diagnosed with acute leukemia will be evaluated during the first days of hospitalization. Based on whether th... | PMC10612155 |
Assignment of interventions: allocation | PMC10612155 | |||
Sequence generation {16a} | acute leukemia | DISEASE, ACUTE LEUKEMIA | The randomization will be carried out by the electronic clinical registry (eCRF) called MACRO. The management of the electronic tool is carried out by the SCReN clinical research platform work-package.After inclusion, the randomization list included in the eCRF will automatically assign the case to the control or exper... | PMC10612155 |
Concealment mechanism {16b} | Allocation concealment will be ensured as MACRO will not release the randomization code until the patient has been recruited into the trial. | PMC10612155 | ||
Implementation {16c} | CRF | DIAZ, CRF | The patient assignment codes are made up of 4 digits. On the one hand is the hospital number, University Hospital Central of Asturias (number 01), Hospital San Pedro Alcantara (number 2), University Hospital Morales Messeguer (number 03), University Hospital La Paz (number 04), University Hospital Fundación Jimenez Dia... | PMC10612155 |
Assignment of interventions: blinding | PMC10612155 | |||
Who will be blinded {17a} | The study is open-label. The investigators and the patient are aware of the treatment administered. The project manager only knows the randomization list, so the investigator does not know the treatment that will be assigned to the patient until the candidate is randomized. The assessors and data analysts will be blind... | PMC10612155 | ||
Procedure for unblinding if needed {17b} | The design is open label with only outcome assessors being blinded, so unblinding will not occur. | PMC10612155 | ||
Data collection and management | PMC10612155 | |||
Plans for assessment and collection of outcomes {18a} | biochemistry and coagulation | SECONDARY | To evaluate the primary and secondary variables of the study, vital signs (blood pressure, heart rate, temperature) will be checked during the physical examination at successive visits. Laboratory tests including blood count, biochemistry and coagulation, electrocardiogram (ECG), microbiological studies, and review of ... | PMC10612155 |
Plans to promote participant retention and complete follow-up {18b} | ADVERSE EFFECTS | An end-of-treatment visit is made to coincide with the last dose of study medication (fosfomycin or ciprofloxacin). And a follow-up visit is scheduled 15 days after the last dose of treatment to perform physical examinations and record adverse effects, ECOG, concomitant treatment, electrocardiogram (ECG), laboratory in... | PMC10612155 | |
Data management {19} | The MACRO® software is a data collection and study management application that uses a secure web browser. It provides access to clinical study data and management of the clinical study process.The objective is that, at the end of the study, all the available forms are as follows:✓ Completed by the investigator✓ With no... | PMC10612155 | ||
Confidentiality {27} | Personal data will be processed in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals regarding the processing of personal data and on the free movement of such data and the relevant local laws.The data collected for the study will be... | PMC10612155 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | MDRGN, neutropenic | INFECTIOUS DISEASES | All study subjects will be screened for MDRGN gut colonization by microbiological culture at the first visit and weekly thereafter during the neutropenic period, until study completion. In each participating center, rectal exudates will be collected in ESwab™ (Copan Diagnostics Inc., Murrieta, CA) that will be sent to ... | PMC10612155 |
Statistical methods | PMC10612155 | |||
Statistical methods for primary and secondary outcomes {20a} | infections, febrile neutropenia, fever | ADVERSE EVENT, NEUTROPENIC FEVER, FEBRILE NEUTROPENIA, ADVERSE EVENT, EVENT, INFECTIONS, SECONDARY, REGRESSION | This phase 3 trial will compare the efficacy of fosfomycin with that of ciprofloxacin in preventing the occurrence of at least one episode of neutropenic fever of infectious origin in a randomized non-inferiority design.The primary endpoint is febrile neutropenia of infectious origin. This analysis will be performed in... | PMC10612155 |
Interim analyses {21b} | An interim analysis will be performed by a data and safety monitoring board (DSMB) for the primary outcome measure after the inclusion of 50 patients. O’Brien- Fleming stopping criteria will be used for the primary outcome (24). If the | PMC10612155 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | There is no planned sub-group analysis. | PMC10612155 | ||
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | FCS | ACUTE LEUKEMIA | To prevent attrition bias, two types of analysis will be performed: an intention-to-treat analysis, in which all randomized patients will be analyzed according to the group to which they were randomized, regardless they received the assigned treatment or not, and, in addition, a per-protocol analysis will be performed ... | PMC10612155 |
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | Dissemination of results directed to patients will be channeled through the Spanish Agency for Medicines and Health Products, and their content will be adapted to patients. | PMC10612155 | ||
Oversight and monitoring | PMC10612155 | |||
Composition of the coordinating center and trial steering committee {5d} | The The
Finally, PIs in each center are responsible for including identifying potential recruits and taking consent. | PMC10612155 | ||
Composition of the data monitoring committee, its role and reporting structure {21a} | A meeting will be held by non-study personnel to evaluate the results of 80 patients. The interim analysis committee will be composed of a hematologist, a microbiologist and a clinical pharmacologist. | PMC10612155 | ||
Adverse event reporting and harms {22} | ADVERSE EVENTS, EVENTS, ADVERSE REACTIONS, ADVERSE EVENT | The investigators will be responsible for collecting all the adverse events in the clinical history based on those referred by the patient spontaneously or by interview during the follow-up visits. The causality of the adverse event related to the intervention will be evaluated and recorded in the clinical history and ... | PMC10612155 | |
Frequency and plans for auditing trial conduct {23} | fever | ADVERSE REACTIONS, EVENTS, SECONDARY, RECRUITMENT | The CRA is a person independent of the research team who is not involved in patient recruitment and follow-up.The local CRA makes a start-up and closing visit to each site. A first visit will take place in each center 30 days after the inclusion of the first patient. Subsequently, 4 to 6 visits will be performed per si... | PMC10612155 |
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | All notifications defined as relevant or non-relevant amendments will be made to the Spanish Agency for Medicines and Health Products and to the Ethics Committee of reference in accordance with Spanish legislation on clinical trials RD 1090/2015 of December 4. These decrees regulate clinical trials with medicinal produ... | PMC10612155 | ||
Dissemination plans {31a} | The results of the present project will be communicated to the scientific community through scientific publications. All publications will be open access. It is foreseen that the project will result in at least 2 peer reviews. All generated data will be accessible and stored in open access data repositories. A list of ... | PMC10612155 | ||
Discussion | neutropenia, febrile neutropenia, fever, infections, transfusional | ACUTE MYELOID LEUKEMIA, NEUTROPENIA, FEBRILE NEUTROPENIA, CNS INFECTIONS, INFECTIONS, GRAM-NEGATIVE BACTERIAL INFECTIONS, DISEASES | The debate on the efficacy of FQ prophylaxis in the era of multidrug resistance is ongoing. Our study will contribute to this debate by comparing the efficacy and safety of ciprofloxacin with fosfomycin in a homogeneous population of patients treated at several centers with different prevalence in MRGNB.The supporters ... | PMC10612155 |
Trial status | MAY, RECRUITMENT | Current version of the protocol is 3.0 of 11 of May 2021.Trial is currently recruiting. The first patient was included in March 2021. At the time of submission, 106 patients have been recruited. The recruitment is expected to be completed by March 2024. | PMC10612155 | |
Acknowledgements | Nicolás | DEL | Institutions and investigators participating in the FOVOCIP groupJavier Fernández Domínguez: Microbiology Department, University Hospital Universitario Central of Asturias.Ana Fernández Verdugo: Microbiology Department, University Hospital Central of Asturias.Pilar Lumbreras Iglesias: Instituto de Investigación Biosani... | PMC10612155 |
Authors’ contributions {31b} | TBC, LLA | TBC | TBC and JFD are the principal investigators of the study. TBC is the clinical coordinator, and JFD coordinates the microbiological part of the study. TBC and JFD have conceived the idea and developed the clinical trial protocol. MGS is responsible for the clinical trial agency at IDIVAL and the SCReN node in Cantabria.... | PMC10612155 |
Funding {4} | FOUNDER | This trial is an investigator-initiated trial which is funded by a National Health Research Projects with the identifier PI21/01590. The founder did not have any role in the design of the study and will not have any role in collection, analysis, and interpretation of data and in writing the manuscript.The funding perio... | PMC10612155 | |
Availability of data and materials {29} | The protocol and the results of the trial will be the exclusive property of the sponsor, who reserves the right to request on its behalf the industrial property rights that may derive from them. There are no agreements with other entities.The principal investigators are responsible for the preparation of the final repo... | PMC10612155 | ||
Declarations | PMC10612155 | |||
Ethics approval and consent to participate {24} | MAY | Ethical approval for this trial, which is in compliance with the Helsinki Declaration and in agreement with the SPIRIT statement, was obtained for the Ethics Committee of Principado de Asturias dated 26 August 2021 to corresponds to version 2.1 (19 August 2021). The protocol amendment version 3.0 was approved by the AE... | PMC10612155 | |
Consent for publication {32} | No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. | PMC10612155 | ||
Competing interests {28} | The authors declare that they have no competing interests. | PMC10612155 | ||
References | PMC10612155 | |||
Objective | People differ in whether they understand graphical or numerical representations of statistical information better. However, assessing these skills is often not feasible when deciding which representation to select or use. This study investigates whether people choose the representation they understand better, whether t... | PMC10625725 | ||
Methods | GIST | In an experiment, 160 participants received information about the benefits and side effects of painkillers using either a numerical or a graphical representation. In the “no choice” condition, the representation was randomly assigned to each participant. In the “choice” condition, participants could select the represen... | PMC10625725 | |
Results | GIST | In the “choice” condition, most (62.5%) chose the graphical format, yet there was no difference in graph literacy or numeracy (nor age or gender) between people who chose the graphical or the numerical format. Whereas choice slightly increased verbatim knowledge, it did not improve gist or overall knowledge compared wi... | PMC10625725 | |
Limitations | The sample consisted of highly educated undergraduate students with higher graph literacy than the general population. The task was inconsequential for participants in terms of their health. | PMC10625725 | ||
Conclusions | When people can choose between representations, they fail to identify what they comprehend better but largely base that choice on how attractive the representation is for them. | PMC10625725 | ||
Highlights | fits | GIST | People differ systematically in whether they understand graphical or numerical representations of statistical information better. However, assessing these underlying skills to get the right representation to the right people is not feasible in practice. A simple and efficient method to achieve this could be to let peop... | PMC10625725 |
What Will Be Chosen Predominantly, and Who Chooses Graphs Rather than Numbers? | fits | Based on the existing literature, we can expect that most people will choose the graphical rather than the numerical representation: graphs are generally preferred,But do people—despite this general preference for graphical representations—choose the representation that fits to their skills such as graph literacy and n... | PMC10625725 | |
Does Being Able to Choose a Representation Foster Knowledge of Statistical Information? | If people who can choose between representations actually succeeded in choosing the representation that they understand better, they should perform better when confronted with knowledge questions compared with people who randomly received either of the representations, and this should hold true for both individuals who... | PMC10625725 | ||
Does Choice Increase Ratings of Accessibility and/or Attractiveness of the Representation? | Subjective ratings of the accessibility of the information as well as of the attractiveness of the representation could yield additional insights into how representations are chosen. As mentioned above, graphical representations have generally been found to be rated as more attractive than numerical ones (e.g., Gaissma... | PMC10625725 | ||
Methods | PMC10625725 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.