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Model selection | REGRESSION | Starting with the full model, tests for multicollinearity were conducted with all variables included, and the model selection process proceeded iteratively by removing variables one at a time until there was no longer a positive test for multicollinearity. Variables found to be most collinear, based on individual multicollinearity tests with non-significant regression coefficients, were removed first. If only significant variables were remaining as collinear, the least significant were removed next. When there was no longer an overall positive test for multicollinearity, remaining statistically insignificant variables were removed and the fit of the model from before and after was compared.Further details on the model selection methodology and a full list of overall and individual tests used for the multicollinearity testing can be found in | PMC10761522 | |
Results | PMC10761522 | |||
Patient demographic and clinical characteristics | PNH | PNH | Data were available for 246 complement inhibitor-naive patients with PNH who were randomized to receive either ravulizumab ( | PMC10761522 |
Associations between variables of interest and PROs | PMC10761522 | |||
Overall results | PNH | PNH | From baseline to day 183, complement C5 inhibitor-mediated reductions in absolute mean LDH levels were significantly associated with improvements in mean FACIT-F score (ΔBL PRO score and laboratory variables over time in patients with PNH: | PMC10761522 |
PROs stratified by LDH response status | In this study, improvement in LDH levels with C5 inhibitor treatment was associated with improvements in FACIT-F and EORTC QLQ-C30 GH scores. Compared with patients with LDH levels ≥ 1.5 × ULN at day 183 (Mean ΔBL PRO scores stratified by LDH levels at day 183 in patients receiving eculizumab or ravulizumab: In patients with LDH levels < 1.5 × ULN at day 183, improvements in mean Hb level were associated with continual improvements in mean FACIT-F score throughout the study period (Fig. Mean ΔBL FACIT-F scores stratified by ΔBL Hb in patients receiving eculizumab or ravulizumab: | PMC10761522 | ||
Discussion | dysphagia, fatigue, abdominal pain, IVH, anemia, PNH, erectile dysfunction | DYSPHAGIA, ANEMIA, NA DEFICIENCY, REGRESSION, PNH, ERECTILE DYSFUNCTION | This Individuals with PNH frequently experience symptoms of fatigue, which contribute to impaired QoL [PNH is characterized by a deficiency of cell surface glycosylphosphatidylinositol-anchored proteins, including the complement regulatory proteins CD55 and CD59. The absence of CD55 and CD59 causes uncontrolled terminal complement activity that leads to IVH, which is indicated by increased LDH levels. IVH releases large amounts of free Hb causing nitric oxide depletion which manifests clinically as symptoms of fatigue, dysphagia, abdominal pain, and erectile dysfunction [In study 301, C5 inhibition with eculizumab or ravulizumab demonstrated significant improvements in key clinical parameters associated with PNH, with 219 patients (90.5%) achieving LDH < 1.5 × ULN at day 183. The improvement seen in LDH levels was associated with improvements in patient fatigue and QoL, as assessed by FACIT-F and EORTC QLQ-C30 GH, respectively. In other studies, improvements in Hb levels associated with C5 inhibition have previously been reported to be associated with QoL outcomes in patients with PNH [To understand the interaction between LDH and Hb in study 301, a regression analysis was performed. The interaction of LDH response with improvements in Hb level was a significant predictor of improvement in fatigue in the current study, demonstrating the significance of LDH level in driving PROs. This is similar to a previous multivariate analysis of data from TRIUMPH, a phase 3 trial of eculizumab and placebo, which demonstrated that a reduction in IVH was better than improvements in anemia in predicting improvements in fatigue [There are limitations to this study that must be considered. Although study 301 collected data covering both physical functioning and fatigue subscales of the EORTC QLQ-C30, only the GH subscale was used for this analysis. Future research may benefit from incorporating additional domains to describe the interactions between clinical outcomes and PROs further. The use of PNH-specific PRO and QoL tools may also be considered in future studies once further validation and psychometric properties have been established. The changes in LDH levels linked to improvements in fatigue and QoL beyond 26 weeks remain unknown. Additionally, study 301 was a controlled trial and may not be reflective of real-world clinical practice. | PMC10761522 |
Conclusions | PNH, fatigue, IVH | PNH | Understanding key clinical drivers of improvements in QoL and fatigue during C5 inhibitor therapy is important for developing appropriate management strategies for patients with PNH. In conclusion, these findings suggest that LDH level, as a surrogate parameter for IVH, is a key determinant of fatigue and QoL outcomes in patients with PNH. Treatment goals, particularly for C5-inhibitor naive patients, should focus on the improvement of LDH levels and subsequent avoidance of IVH, which C5 inhibitors have been demonstrated to successfully achieve. | PMC10761522 |
Acknowledgements | RARE DISEASE | Writing assistance was provided by Vikte Lionikaite, PhD, Stephen McKenna, MSc, and Rebecca Hornby, PhD, of Oxford PharmaGenesis, Oxford, UK, with funding from Alexion, AstraZeneca Rare Disease. | PMC10761522 | |
Author contribution | RPL | RECRUITMENT | This study was conceptualized by AW and designed by AW with refinement by IT and YP. EP and AC performed the coding and statistical analysis, and HS, AK, LM, RPL, TD, SO, RW, and JWL contributed to patient recruitment, data collection, and interpretation of the results. All authors reviewed the data and contributed to the writing of the manuscript. All authors read and approved the final manuscript. | PMC10761522 |
Funding | RARE DISEASE | Open Access funding enabled and organized by Projekt DEAL. Alexion, AstraZeneca Rare Disease. | PMC10761522 | |
Data availability | RARE DISEASE | Alexion, AstraZeneca Rare Disease will consider requests for disclosure of clinical study participant-level data provided that participant privacy is assured through methods such as data de-identification, pseudonymization, or anonymization (as required by applicable law), and if such disclosure was included in the relevant study informed-consent form or similar documentation. Qualified academic investigators may request participant-level clinical data and supporting documents (statistical analysis plan and protocol) pertaining to Alexion-sponsored studies. Further details regarding data availability and instructions for requesting information are available in the Alexion Clinical Trials Disclosure and Transparency Policy at Link to data-request form: | PMC10761522 | |
Declarations | PMC10761522 | |||
Ethics approval and consent to participate | The protocol for study 301 (NCT02946463) was approved by the institutional review board or independent ethics committee at each participating center, and the study was conducted in accordance with the Declaration of Helsinki and the Council for International Organizations of Medical Sciences International Ethical Guidelines. All patients gave written informed consent. | PMC10761522 | ||
Competing interests | MITCHELL, RARE DISEASE, WELLS | Hubert Schrezenmeier has received travel support, fees, and research support (to University of Ulm) from Alexion, AstraZeneca Rare Disease, and Novartis, and fees (to University of Ulm) from Apellis, Roche, and Sanofi. Austin Kulasekararaj has received fees for service, travel support, and consulting fees from Alexion, AstraZeneca Rare Disease. Lindsay Mitchell has received fees from Alexion, AstraZeneca Rare Disease. Prof de Latour received fees for service, travel support, consulting fees and served as a member of an advisory board for Alexion, AstraZeneca Rare Disease, Novartis and Pfizer. Timothy Devos has served as a member of an advisory board for AbbVie, Alexion, AstraZeneca Rare Disease, Celgene/Bristol Myers Squibb, and Novartis. Shinichiro Okamoto has received fees and research funding from Alexion, AstraZeneca Rare Disease. Richard Wells has received fees and research funding from Alexion, AstraZeneca Rare Disease, Celgene, and Novartis, and consulting fees from Alexion, AstraZeneca Rare Disease. Evan Popoff and Antoinette Cheung are full-time employees of Broadstreet HEOR. Yogesh Patel is a full-time employee of Alexion, AstraZeneca Rare Disease. Ioannis Tomazos and Alice Wang were full-time employees of Alexion, AstraZeneca Rare Disease at time of study. Jong Wook Lee has received grants and fees from Alexion, AstraZeneca Rare Disease, and has served as a member of an advisory board for Alexion, AstraZeneca Rare Disease. | PMC10761522 | |
References | PMC10761522 | |||
Background | DISEASES | Vaccine hesitancy is a concerning menace to the control of vaccine-preventable diseases. Effective health communication could promote an overall understanding of the importance, risks, and benefits of vaccination and reduce vaccine hesitancy. | PMC10273550 | |
Methods | DISEASE | In this survey, four fictitious newspaper articles addressing an emerging bogus disease and its vaccine were randomly assigned to participants. The first version focused on information about the disease; the second was akin to the first, including a case description and image. The third version focused on vaccine safety/efficacy; the fourth version was like the third, including a case description and image. After reading a single version of the article, participants responded if they would take the vaccine and if they would vaccinate their children. We used chi-squared tests for comparisons and investigated interactions with vaccine-hesitant attitudes. | PMC10273550 | |
Results | DISEASE, DISEASE CHARACTERISTIC | We included 5233 participants between August/2021 and January/2022; 790 were caregivers of a child ≤ 5 years old, and 15% had prior vaccine hesitancy. Although most declared intention to take the vaccine, the percentage was highest among those exposed to the newspaper article focusing on the vaccine safety/efficacy with the case description and picture (91%; 95% confidence interval 89–92%), and lowest among participants exposed to the article focusing on the disease with no case description (84%; 95% confidence interval 82–86%). Similar trends were observed in the intention of offspring vaccination. We found evidence of effect modification by vaccine-hesitant attitudes, with a higher impact of communication focusing on vaccine safety/efficacy compared to that focusing on disease characteristics among hesitant participants. | PMC10273550 | |
Conclusion | Communication strategies focusing on different aspects of the disease-vaccine duet may impact vaccine hesitancy, and storytelling/emotive imagery descriptions may improve risk perception and vaccine uptake. Moreover, the effect of message framing strategies may differ according to previous vaccine hesitant attitudes. | PMC10273550 | ||
Keywords | PMC10273550 | |||
Introduction | infectious diseases, viral disease, yellow fever, hepatitis A, tetanus | INFECTIOUS DISEASES, VIRAL DISEASE, YELLOW FEVER, SMALLPOX, PERTUSSIS, HEPATITIS A, TETANUS, POLIO | Mass vaccination has been adopted for almost two centuries to prevent infectious diseases such as smallpox, polio, tetanus, pertussis, hepatitis A and B, HPV, and yellow fever [Vaccine effectiveness depends not only on the availability of resources but also on mass acceptance and uptake of accessible vaccines. Vaccine hesitancy is defined as the delay in acceptance or refusal to vaccinate despite the availability of vaccination services [Health communication strategies are essential tools to address vaccine hesitancy [In this randomized experiment, we investigate the effect of different communication strategies on the intention to receive a vaccine for a bogus emerging viral disease and the intention of offspring vaccination. We also explored interactions between communications strategies and prior vaccine-hesitant attitudes. | PMC10273550 |
Methods | this disability, fever, meningitis, pain, infection, Meningitis, deaths, four-year-old, hearing lossThere | ADVERSE REACTIONS, VIRUS, STILL, MENINGITIS, ADVERSE EVENT, DISEASE, RECRUITMENT, INFECTION, MENINGITIS, ALBERT | In this survey experiment, we recruited participants ≥ 18 years old living in Brazil using social media appliances (Instagram and WhatsApp) disseminated by the study investigators, the study's official social media profiles, and the official profiles of Faculdade de Medicina da Universidade de Sao Paulo. Participants responded to a self-administered electronic questionnaire including three sections: 1-demographics; 2-intention to receive a vaccine to prevent an emerging bogus disease and to vaccinate their offspring if applicable; and 3-knowledge/attitudes regarding vaccines. Before section 2, each participant was exposed to a fictitious newspaper article describing a bogus disease and its vaccine. Four versions of the newspaper article were randomly assigned to study participants, with each participant having access to a single version (Fig. Schematic of study recruitment and proceduresNewspaper articles describing an emerging bogus disease and its vaccineNewspaper article Version 1Group 1Newspaper articleVersion 2Group 2In Brazil, four-year-old Pedro was the first case observed in the country, generating much commotion. The child was hospitalized for 28 days at Hospital das Clinicas, Universidade de Sao Paulo, and survived. Still, the infection resulted in irreversible hearing lossThere is still no specific treatment for HAMV, but a vaccine against the virus is under development. Pedro's father, mechanic Valdir Amilton, 39, regretted that the immunization was not available sooner: "Now we will have to cope with this disability, but at least other people will not have to go through it." The vaccine is expected to be available within a few weeks in Brazil, with distribution led by the national health systemNewspaper articleVersion 3Group 3Newspaper articleVersion 4Group 4Several countries, including Brazil, have already implemented vaccination campaigns against the Human Acute Meningitis Virus (HAMV), which causes severe meningitis and has resulted in more than 500 deaths across five continents since February 2020The vaccine is given as a single dose and was found to be safe in two large studies with more than 10,000 people in the United Kingdom and Australia. Mild adverse reactions were observed in only 10% to 15% of study participants. Adverse events include pain at the injection site and low-grade fever. According to experts and health authorities, the vaccine is highly effective, protecting more than 95% of children ten days after vaccinationFour-year-old Pedro was the first case observed in Brazil, generating much commotion. The child was hospitalized for 28 days at Hospital das Clinicas, Universidade de Sao Paulo, and survived. Still, the infection resulted in irreversible hearing lossThere is still no specific treatment for HAMV, but a vaccine against the virus is under development. Pedro's father, mechanic Valdir Amilton, 39, regretted that the immunization was not available sooner: "Now we will have to cope with this disability, but at least other people will not have to go through it."In Brazil, the vaccine is available at public primary care clinics, private clinics, and select drugstoresThe primary dependent variables in our analyses were the reported intention to take the vaccine and the intention of offspring vaccination.As other studies have shown that the effect of specific message framing strategies may differ according to prior (hesitant) beliefs regarding vaccines [We used the REDCap platform [The DEBRA study has been reviewed and approved by the Ethics Committees at Hospital Israelita Albert Einstein (Nº 5,246,486) and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Nº 4,737,962). All subjects or their legal guardian(s) provided informed consent before inclusion in the study. We collected no identifiable private information from study participants. All methods were carried out following relevant guidelines and regulations. Images presented in Table We compared demographic characteristics in each group using Kruskal–Wallis tests and chi-squared tests as appropriate, with a 0.05 significance level. We describe counts, percentages, and 95% confidence intervals (CI) for responses concerning the intention to receive a vaccine and to vaccinate offspring in each study group; two by two comparisons were also performed using chi-squared tests. We calculated prevalence ratios comparing groups according to prior hesitant beliefs and explored the presence of multiplicative interaction using Mantel–Haenszel's homogeneity tests. We handled missing as missing completely at random. We used Stata (StataCorp. College Station, TX: StataCorp LP) version 15.1 in all analyses. | PMC10273550 |
Results | PMC10273550 | |||
Intention to vaccinate offspring against the emerging bogus disease | Among the 790 participants who declared themselves to be parents or legal caregivers of a child ≤ 5 years old, 732 (93%) provided valid answers to the question on the intention to vaccinate their offspring. Responses are presented in Table Other responses in the third section of the questionnaire, concerning knowledge/attitudes regarding vaccines, will be analyzed and presented in a separate manuscript. | PMC10273550 | ||
Acknowledgements | We thank Faculdade de Medicina da Universidade de Sao Paulo for promoting our study in the institution's official Instagram profile. | PMC10273550 | ||
Authors’ contributions | VIAS, RV, and MTC conceptualized the study. VIAS, RV, LF, CLAB, and MTC produced the study questionnaire. SNFS and MEMS worked of the electronic data collection form. LF and TM revised the fictitious newspaper article. All authors contributed with promoting the study in social media venues. VIAS performed statistical analysis. VIAS and MTC wrote the manuscript. VIAS and MTC verified the underlying data. All author revised and approved the final version of the manuscript. All authors had full access to all the data in the study and accept responsibility to submit for publication. | PMC10273550 | ||
Funding | This work was not supported by any specific fund. | PMC10273550 | ||
Availability of data and materials | Currently, the datasets used and analyzed during the study are available from the corresponding author at reasonable request. | PMC10273550 | ||
Declarations | PMC10273550 | |||
Ethics approval and consent to participate | ALBERT | The DEBRA study has been reviewed and approved by the Ethics Committees at Hospital Israelita Albert Einstein (Nº 5,246,486) and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Nº 4,737,962). We obtained informed consent from all subjects or their legal guardian(s) before inclusion in the study. We collected no identifiable private information from study participants. All methods were carried out following relevant guidelines and regulations. Images in Table | PMC10273550 | |
Consent for publication | Not applicable. | PMC10273550 | ||
Competing interests | The authors declare no competing interests. | PMC10273550 | ||
References | PMC10273550 | |||
Background | tinnitus distress, Tinnitus, tinnitus | DISEASE, TINNITUS, TINNITUS | Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. | PMC10367236 |
Methods | tinnitus distress, Tinnitus, tinnitus | AIDS, TINNITUS, TINNITUS | Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. | PMC10367236 |
Discussion | tinnitus | TINNITUS | The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. | PMC10367236 |
Trial registration | ClinicalTrials.gov Open Access funding enabled and organized by Projekt DEAL. | PMC10367236 | ||
Background | UNITI, Tinnitus, tinnitus | DISEASE, TINNITUS, TINNITUS | Tinnitus is a common condition associated with a high global disease burden. Currently, there is no universal treatment or cure for tinnitus [A study protocol for UNITI-RCT has previously been published [The UNITI-RCT is executed in five clinical centers across the EU. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis. The already published study protocol delineates the rationale and methods of the study, its population plus the respective inclusion and exclusion criteria, the description of outcome measures, collected covariates, and the used interventions. As a follow-up to the study’s protocol, this statistical analysis plan (SAP) aims to further describe the statistical techniques in more detail used to address the primary objectives of the RCT. To increase the transparency of data analysis, this plan will be made public before database closure (UNITI website: | PMC10367236 |
Methods/design | PMC10367236 | |||
Patient population | chronic subjective tinnitus, word of mouth | Each center aims to enroll 100 patients for the RCT, for a total number of 500 patients with chronic subjective tinnitus (i.e., lasting for at least 6 months). At all sites, potential candidates are recruited via media advertising (according to local regulations) as well as on an individual basis at the clinical sites through, e.g., information sheets, word of mouth, or conversations with medical staff. | PMC10367236 | |
Outcomes | Tinnitus | SECONDARY, TINNITUS | The Tinnitus Handicap Inventory (THI) will be used as a primary outcome measure (see Table Additional measures which are not defined as primary or secondary outcomes but may be used for sample description and additional analyses include: European School of Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ [ | PMC10367236 |
Intervention | PMC10367236 | |||
Treatment conditions | The main objective of the UNITI RCT is to investigate the effects of four different interventions (SC, ST, HA, CBT) and the combinations of these interventions (CBT and HA, CBT and SC, CBT and ST, HA and SC, HA and ST, SC and ST). Internal standard operation procedures were developed, and workshop training was conducted to ensure harmonization among the participating clinical sites with regard to the procedure, technical equipment, and training of the research staff. A full description of each of the four treatments is available in the study protocol [ | PMC10367236 | ||
Randomization and blinding | tinnitus | TINNITUS | Eligible participants are randomly allocated to one of ten treatment arms of single or combinational treatments (see Fig. Randomization scheme as shown in the study protocol. Figure reproduced from [Table Expected randomization per center and per treatmentThe randomization of patients takes place at each clinical site and is monitored centrally. A specific interactive web response system (IWRS) is used to support each clinical site with the randomization of their patients. This facilitates the management of many patients from different sites located in several countries and the monitoring of the multicentric study with a complex design. The distribution across the four strata is centrally monitored during the randomization process. If a recruited and eligible participant quits the RCT participation before randomization, this participant is considered a screening failure. In case an eligible participant is already randomized to a treatment group and quits study participation, this patient is considered a dropout.The local clinical staff will enter clinical data into a central tinnitus database [ | PMC10367236 |
General principles of statistical analysis | A two-sided | PMC10367236 | ||
Sample size calculation | A sample size of 500 participants has been calculated based on conservative estimates of the effect size from previous clinical trials delivering CBT, SC, and ST, with the aim to achieve enough statistical power to address objective 1; see the study protocol [ | PMC10367236 | ||
Timing of analysis | blindness | BLINDNESS | An initial data exploration is conducted during data collection to ensure the integrity (i.e., the overall completeness and accuracy) of the data stored in the database. No interim analyses are planned. Data preparation, such as data cleaning (e.g., standardizing variable names, encoding categorical variables as factors) and munging will take place for each center after the final visit of the last patient is recorded, as well as plausibility checks. Exploratory data analysis with graphical methods (e.g., histograms, bar-plots, scatterplots, graphical exploration of missing values) will also be conducted for each center after the final visit of the last patient is recorded. The initial and exploratory data analysis, as well as the analysis of the main results, will be carried out by the statistical analysis team [JS, SG, CJ, UN, MSp, ME, NW, LB] with the pseudo-anonymized treatment code, and therefore, treatment blindness will be preserved. The main RCT analyses will include data from patients who have finished their treatment by 19 December 2022. After that date, the data cleaning process will begin. Secondary outcome analysis is planned to occur when the 48-week follow-up period has been reached for participants included in the primary outcome analysis. | PMC10367236 |
Statistical software | All preprocessing and statistical analysis will be conducted in R. Data wrangling will be done with the “tidyverse” packages [ | PMC10367236 | ||
Subject disposition | The flow of participants through the clinical trial stages will be shown with a diagram following the guidelines of the Consolidated Standards Of Reporting Trials (CONSORT) [ | PMC10367236 | ||
Participant characteristics | Baseline participant characteristics will be presented descriptively in a standardized manner as shown in Tables Baseline characteristics stratified based on center
Baseline characteristics stratified based on treatment received | PMC10367236 | ||
Treatment compliance/adherence and protocol deviations | Compliance with treatment protocols is defined for each treatment arm separately. For combined treatments, failing to meet the criteria for one of the arms is sufficient to identify a patient as failing to comply with the protocol. Table The number and percentage of participants compliant with treatment will be presented per treatment group. Compliance is determined by App-use log files (SC, ST), hearing aid log files (HA), and participation in treatment sessions (CBT). Acceptable compliance will be defined as ≥ 50% of the recommended intervention (participation in ≥ 6 CBT sessions including the first two, using HA four or more hours per day, on average, according to data logging, having completed at least the first 6 chapters of SC and having played at least once each of the four ST stimuli categories). Withdrawal from/compliance with the randomized intervention will be summarized using the following variables:Number of treatment discontinuations;Number of patients who decided to continue with study visits even though they canceled their treatment;Discontinuation reasons (where available);Compliance with the intervention (in percent), as described in Table All cases of protocol deviations will lead to an exclusion of the respective participant from the per protocol analysis. A list of deviations will be presented in a table including the treatment arm and details of the deviation. Protocol deviations are defined as any deviations from the study protocol [ | PMC10367236 | ||
Concomitant therapies | Type and frequency of concomitant medication and treatment will be categorized and presented descriptively. | PMC10367236 | ||
Adjusted analysis | depression | SECONDARY | In addition to the model described above, sensitivity analysis will be conducted by adjusting the model with the following fixed effects: age, gender, educational attainment, hearing aid indication, and depression according to the PHQ-9 measured during baseline. Adjusted fixed effects estimates will be reported with their 95% confidence intervals. The model equation for the adjusted model will look as follows:Unadjusted and adjusted models will also be fitted for the secondary outcomes. | PMC10367236 |
Treatment of missing data | Multiple imputation techniques [ | PMC10367236 | ||
Analysis of safety outcomes | Between-group analysis of safety outcomes will be presented descriptively, as outlined in the study protocol [ | PMC10367236 | ||
Adverse events (AE) | ADVERSE EVENTS, EVENTS, ADVERSE EVENT | ICD-10 codes will be used for all reported adverse events. Serious adverse events as identified by Good Clinical Practice §3 are described in terms of relatedness to treatment (yes/no) and whether the adverse event was expected (yes/no) [Death;Threat to life;Requirement for hospitalization or extension of current hospitalization;Persistent disability or incapacity;Medically relevant events (e.g., allergy).The number of treatment-related adverse events is reported divided by their relationship to treatment (“doubtful,” “possible,” “probably,” and “certain”). | PMC10367236 | |
Acknowledgements | Not applicable. | PMC10367236 | ||
Additional information | NCT04663828• | • Trial registration: NCT04663828• SAP Version: 1.1, Date: April 3, 2023.• This document has been written based on information contained in the study protocol, version no. 3., dated November 4, 2021 [• Signatures:Signature of person writing the SAP: Jorge Piano Simoes
Signature of senior statistician responsible: Winfried Schlee
Signature of chief investigator/clinical lead: Stefan Schoisswohl
| PMC10367236 | |
Authors’ contributions | MR, WS | Jorge Piano Simoes (JPS): drafting of manuscript; provided critical feedback to manuscript. / Stefan Schoisswohl (SSch): drafting of manuscript; contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Winfried Schlee (WS): drafting of manuscript; contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Laura Basso (LB): drafting of manuscript; provided critical feedback to manuscript. / Alberto Bernal-Robledano (ABR): participated in data collection; provided critical feedback to manuscript. / Benjamin Boecking (BB): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Rilana Cima (RC): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Sam Denys (SD): participated in data collection; provided critical feedback to manuscript. / Milena Engelke (ME): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Alba Escalera-Balsera (AEB): participated in data collection; provided critical feedback to manuscript. / Alvaro Gallego-Martinez (AGM): provided critical feedback to manuscript. / Silvano Gallus (SG): drafting of manuscript; provided critical feedback to manuscript. / Dimitris Kikidis (DK): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Jose Antonio López-Escámez (JALE): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Steven C. Marcrum (SCM): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Nikolaos Markatos (NM): provided critical feedback to manuscript. / Juan Martin-Lagos (JML): provided critical feedback to manuscript. / Marta Martinez-Martinez (MMM): provided critical feedback to manuscript. / Birgit Mazurek (BM): drafting of manuscript; contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Evgenia Vassou (EV): provided critical feedback to manuscript. / Carlotta Micaela Jarach (CMJ): drafting of manuscript; provided critical feedback to manuscript. / Nicolas Mueller-Locatelli (NML): participated in data collection; provided critical feedback to manuscript. / Patrick Neff (PN): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Uli Niemann (UN): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Hafez Kader Omar (HKO): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Clara Puga (CP): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Miro Schleicher (MSchl): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Vishnu Unnikrishnan (VU): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Patricia Perez-Carpena (PPC): provided critical feedback to manuscript. / Rüdiger Pryss (RP): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Paula Robles-Bolivar (PRB): provided critical feedback to manuscript. / Matthias Rose (MR): provided critical feedback to manuscript. / Martin Schecklmann (MSche): drafting of manuscript; contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Tabea Schiele (TS): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Johannes Schobel (JS): participated in data collection; provided critical feedback to manuscript. / Myra Spiliopoulou (MSp): contributed to study design/data analysis strategy; provided critical feedback to manuscript. / Sabine Stark (SSt): contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. / Nicolas Verhaert (NV): provided critical feedback to manuscript. / Carsten Vogel (CV): participated in data collection; provided critical feedback to manuscript. / Nina Wunder (NW): drafting of manuscript; provided critical feedback to manuscript. / Zoi Zachou (ZZ): participated in data collection; provided critical feedback to manuscript. / Berthold Langguth (BL): drafting of manuscript; contributed to study design/data analysis strategy; participated in data collection; provided critical feedback to manuscript. The authors read and approved the final manuscript. | PMC10367236 | |
Funding | UNITI | Open Access funding enabled and organized by Projekt DEAL. The UNITI project has received funding from the European Union’s Horizon 2020 Research and Innovation Program (grant agreement number 848261). | PMC10367236 | |
Availability of data and materials | tinnitus | TINNITUS | All investigators from UNITI-RCT have access to the study data stored in the tinnitus database [ | PMC10367236 |
Declarations | PMC10367236 | |||
Ethics approval and consent to participate | Approval for the UNITI-RCT was obtained by the local ethics committees at all investigator clinical sites and all participants provided written informed consent; detailed information can be found in the study protocol [ | PMC10367236 | ||
Consent for publication | Not applicable. | PMC10367236 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10367236 | ||
References | PMC10367236 | |||
ABSTRACT | PMC10292617 | |||
Objectives: | to identify the effect on satisfaction and self-confidence of undergraduate nursing students after using a validated bed bath video during the simulation. | PMC10292617 | ||
Methods: | blinded parallel randomized clinical trial. Participants were allocated to the control group (simulation with tutor) or intervention (simulation with video). After the interventions, the Student Satisfaction and Self Confidence with Learning Scale was used to assess satisfaction and self-confidence. The study was approved by the Ethics Committee and Brazilian Registry of Clinical Trials. Mann Whitney, Fisher Exact and Student t statistical tests were used. A significance level of 5% was adopted | PMC10292617 | ||
Conclusions: | satisfaction and self-confidence were similar between the groups, and the two strategies could be used in the simulated practice of bed bathing. | PMC10292617 | ||
RESUMO | PMC10292617 | |||
Objetivos: | identificar o efeito na satisfação e autoconfiança de estudantes do curso de graduação em Enfermagem após uso de um vídeo validado sobre o banho no leito durante a simulação. | PMC10292617 | ||
Métodos: | estudo clínico randomizado paralelo e cego. Os participantes foram alocados no grupo-controle (simulação com tutor) ou intervenção (simulação com vídeo). Após as intervenções, utilizou-se a Escala de Satisfação dos Estudantes e Autoconfiança com a Aprendizagem para avaliar a satisfação e autoconfiança. O estudo foi aprovado pelo Comitê de Ética e Registro Brasileiro de Ensaios Clínicos. Foram utilizados os testes estatísticos Mann Whitney, Exato de Fisher e | PMC10292617 | ||
Resultados: | Não houve diferença | avaliaram-se 58 estudantes (30, controle; e 28, intervenção). Não houve diferença significante entre os grupos quanto à satisfação (p=0,832) e autoconfiança (p>0,999). | PMC10292617 | |
Conclusões: | satisfação e autoconfiança foram similares entre os grupos, e as duas estratégias poderão ser utilizadas na prática simulada do banho no leito. | PMC10292617 | ||
RESUMEN | PMC10292617 | |||
Objetivos: | DEL | identificar efecto en la satisfacción y autoconfianza de estudiantes del curso de grado en Enfermería tras uso de video validado sobre baño en el lecho durante el simulado. | PMC10292617 | |
Métodos: | estudio clínico randomizado paralelo y ciego. Los participantes fueron ubicados en grupo control (simulado con tutor) o intervención (simulado con vídeo). Tras intervenciones, utilizado la Escala de Satisfacción de Estudiantes y Autoconfianza con el Aprendizaje para evaluar satisfacción y autoconfianza. El estudio aprobado por el Comité de Ética y Registro Brasileño de Ensayos Clínicos. Utilizadas pruebas estadísticas Mann Whitney, Exacta de Fisher y | PMC10292617 | ||
Resultados: | evaluados 58 estudiantes (30, control; y 28, intervención). No hubo diferencia significante entre los grupos cuanto a la satisfacción (p=0,832) y autoconfianza (p>0,999). | PMC10292617 | ||
Conclusiones: | DEL | satisfacción y autoconfianza fueron similares entre los grupos, y las dos estratégias podrán ser utilizadas en la práctica simulada del baño en el lecho. | PMC10292617 | |
Descriptors: | PMC10292617 | |||
Descriptores: | PMC10292617 | |||
Descritores: | PMC10292617 | |||
INTRODUCTION | paralysis | The bed bath is a procedure performed by the nursing team and is considered essential for the recovery of patients. It is indicated for bedridden individuals in permanent conditions, such as paralysis; or temporary, such as some surgeries or illnessesWhen not performed in a safe and adequate manner, the bed bath procedure puts the patient’s physical integrity at risk, and may cause: accidents due to falls, accidental removal of devices, infectionsThe knowledge of the technique and the necessary skills to perform nursing procedures are taught from the undergraduate course. For some years, universities have been implementing new active teaching strategies, such as clinical simulation, which help in the development of clinical reasoning and in the training of technical skills, which contributes both to the safety of patients and future professionalsThe simulation allows the partial or total reproduction of a real clinical situation in a safe and controlled environment; its application is related, in general, to practical activities that involve decision-making or skills training in certain proceduresThe use of video is effective in acquiring cognitive capacity, improving retention of information and skills and can add satisfaction and self-confidence in learningSatisfied and self-confident students become more motivated to learn and tend to better master the contents and clinical skills taught to them; consequently, they become more capable of executing what they have learned in clinical practiceIn this sense, it is essential to identify teaching tools that increase these perceptions, because, in the literature, there is still a lack of studies that compared satisfaction and self-confidence in learning between different teaching strategies | PMC10292617 | |
OBJECTIVES | To identify the effect on satisfaction and self-confidence of undergraduate nursing students after using a validated bed bath video during the simulation. | PMC10292617 | ||
METHODS | PMC10292617 | |||
Ethical aspects | The study was approved by the Research Ethics Committee of the university and registered in the Brazilian Registry of Clinical Trials - ReBEC (RBR-2tyxttk). All participants signed the Free and Informed Consent Form (FICF). | PMC10292617 | ||
Design, period, and place of study | This is a blinded parallel randomized clinical study, in which the Consolidated Standards of Reporting Trials (CONSORT) references were adopted. Data were collected in August 2021 at the Center for Teaching Skills and Simulation of a public university in the city of São Paulo, state of São Paulo (SP), Brazil. | PMC10292617 | ||
Population, inclusion, and exclusion criteria | The population consisted of all students aged over 18 years old and regularly enrolled in the second year of the undergraduate nursing course in the academic year of 2021 and who attended the Fundamentals of Nursing Care discipline. Those who were on sick leave during the data collection period and those who did not attend the theoretical class on bed bath were excluded. | PMC10292617 | ||
Study protocol | SCLS, blindness | BLINDNESS | In the present study, this data collection procedure was followed: first, the students attended a dialogued expository class on bed baths, structured based on the literature. The class lasted approximately one hour and was taught by a professor of Fundamentals of Nursing Care, who was the tutor of the practical simulations.After the class, the study subjects were asked about their desire to participate and make the data collected available for research, and those who agreed signed the FICF. After three days of theoretical class, students were invited to attend the Center for Teaching Skills and Simulation and were randomly allocated into one of two groups (intervention or control). Block randomization was performed using the RandomThe intervention group (Group 1) consisted of students who watched the video, prepared and validated previouslyAfter the simulated practice, the students were invited to move to another room to fill out the data collection instrument, consisting of two parts: the first contained closed questions about personal data (gender - female and male, age in complete years and experience prior execution of bed bath in clinical practice or teaching - yes or no); and the second was the Student Satisfaction and Self-Confidence with Learning Scale (SCLS), which was the outcome of the study. This instrument was applied by a student of the postgraduate course in Nursing, master’s level (Researcher 3), who was not aware of which group the student belonged to (control or intervention), thus maintaining the blindness of this phase.The Student Satisfaction and Self-Confidence with Learning Scale was created in 2003 by the National League of Nursing (NLN) | PMC10292617 |
Analysis of results and statistics | The collected data were entered into a Microsoft Excel | PMC10292617 | ||
RESULTS | The sample consisted of 58 students, 28 from the intervention group and 30 from the control group (
| PMC10292617 | ||
Clinical trial flowchart according to CONSORT 2010, São Paulo, São Paulo, Brazil, 2021 | In | PMC10292617 | ||
Age, gender, and previous experience of performing a bed bath for participants in the intervention and control groups, São Paulo, São Paulo, Brazil, 2021 |
In | PMC10292617 | ||
Analysis of satisfaction and self-confidence between groups, São Paulo, São Paulo, Brazil, 2021 | PMC10292617 | |||
DISCUSSION | anxiety | Teaching is constantly evolving. In this sense, adapting and updating teaching methods and tools are essential to ensure competent training of future professionalsIt is known that people have different abilities when it comes to learning. Some will find a particular teaching strategy to be a great way to learn; for others, it may be ineffective. Therefore, it is essential to investigate the different ways in which students learn, which methods and tools help in this process; and identify different learning patternsThere are still few studies that have analyzed the impact of using video associated with simulation. A Brazilian study analyzed: the effectiveness of using video associated with the simulation of port-a-cath catheter handling in anxiety; and the knowledge of 24 nursing studentsA blinded, parallel randomized clinical trial showed that the use of video during the simulation increased the psychomotor skills of 56 second-year undergraduate Nursing students compared to the group that simulated the bed bath with guidance from a tutor (p. = 0.003)Although the researchers point out that the use of video improves psychomotor skills, no research was identified that analyzed the effect of this tool on students’ satisfaction and self-confidence.In the present study, it was observed that there was no difference between the simulation using the video and the one with a tutor in the level of satisfaction and self-confidence in learning. This result may be related to the fact that the simulated practices, regardless of the association of other tools, are carried out in a controlled environment, which can make the student more satisfied and self-confident - results, these, found by other researchersA study carried out with 117 nursing students in Saudi Arabia showed that clinical simulation contributed to satisfaction (average of 3.76 to 4.0) and provoked a high level of self-confidence (average of 3.76 to 4.14) and motivation in the studentsAnother quasi-experimental study carried out in Brazil with 32 nursing undergraduate students, aimed at analyzing the effectiveness of simulation on self-confidence for out-of-hospital cardiopulmonary resuscitation, showed that this teaching strategy was effective in increasing nursing students’ self-confidence, to the execution of this emergency service. The results of this study revealed that there were statistically significant differences (p < 0.001) in the answers to all questions on the Self-Confidence Scale, when compared before and after the simulationThese same results were identified in a study carried out in the United States, with 61 students, in which simulation was used to teach community pediatrics for five weeks. The results showed that the average satisfaction and self-confidence of the students was 4.04+0.44. In the subscale “Satisfaction with learning”, the average score was 4.10+0.50, and the item that had the highest score was “The way the teacher taught was adequate for the way in which the student learns” (mean of 4.21+0.75). As for the subscale “Self-confidence in learning”, the results showed an average score of 4.00+0.46, and the item with the highest score was “It is my responsibility as a student to learn what I need to know through the simulation activity” (average of 4.26+0.72). The researchers of this study concluded that students were highly satisfied and self-confident with the teaching strategy and that simulation can connect theory with practiceResearchers from Spain analyzed the satisfaction of 91 nursing students in their second year of graduation regarding the simulated practice of initial patient assessment and monitoring of vital signs. In this study, the Simulated Clinical Experience Satisfaction Scale was used, consisting of 17 items and a ten-point Likert scale, where 1 indicates the lowest level of satisfaction: and 10, the greatest. The results indicated high levels of satisfaction when using this teaching strategy, with an overall score of 9.3A Portuguese quasi-experimental study that analyzed the cognitive knowledge, satisfaction, and self-confidence of 94 Nursing students in the face of the simulation of a nursing consultation on vaccination showed that the use of the simulation not only improves knowledge compared to the traditional strategy (p < 0.000), but also promotes student satisfactionAnother quasi-experimental investigation, carried out in Turkey with 139 nursing students, whose objective was to compare the effect of different simulation modalities on levels of knowledge, skill, stress, satisfaction and self-confidence, showed high levels of satisfaction (mean of 4.01+ 0.85) and self-confidence (mean of 4.06+0.69) for those students who used a dummy in the simulationIn clinical nursing practice, satisfaction and self-confidence are essential factors because, in addition to helping students to complete their tasks accurately, they allow professionals to build a relationship of trust with their patients | PMC10292617 | |
Study limitations | As limitations of the study, the study was carried out in a single center and with a small sample. In this sense, the results found cannot be generalized to students with different characteristics from our population. Another limitation was the impossibility of analyzing the level of satisfaction and self-confidence before the interventions. However, it should be noted that the scale used is composed of questions that analyze these constructs after the simulation, not allowing their application before the interventions. | PMC10292617 | ||
Contributions to the field | The use of video can be an attractive and innovative tool to be used during the simulation. The method adopted in the present study can be replicated for other procedures, contributing to the advancement of teaching, and learning in nursing. | PMC10292617 | ||
CONCLUSIONS | ALMEIDA | There was no difference in the level of satisfaction and self-confidence in learning among undergraduate Nursing students when they simulated the bed bath with a tutor or with the video. Both strategies can be used to ensure satisfaction and self-confidence in the simulated bed bath practice.
This study was funded by the National Council for Scientific and Technological Development (CNPq), CNPq process number 454707/2014-2 and 309586/2021-6 and by the Coordination for the Improvement of Higher Education Personnel (CAPES).EDITOR IN CHIEF: Antonio José de Almeida FilhoASSOCIATE EDITOR: Priscilla Valladares Broca | PMC10292617 |
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