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1. Introduction
ill
RECRUITMENT
The author (Barbara D’Amen) carried out the project activities and contributed to the writing of the article as a researcher at the Centre for Socio-Economic Research on Ageing, National Institute of Health and Science on Ageing (IRCCS INRCA). Since 15 January 2023, she has been a researcher at the Italian National Ins...
PMC10049644
2. Materials and Methods
The ME-WE project included a wide range of quantitative and qualitative research, co-design and knowledge translation activities dealing with the phenomenon of AYCs in Europe. Below, we describe, review and critique the methods and recruitment-related aspects of the trial evaluating the newly designed psychosocial inte...
PMC10049644
2.1. Design
The ME-WE psychosocial intervention was designed as a cluster-randomised controlled trial (C-RCT) design, with a two (arm) by three (times) repeated measures factorial design [Clusters consisted of AYCs attending the same school (in Slovenia, Sweden and Switzerland) or living in the same geographical area (e.g., neighb...
PMC10049644
2.2. Intervention
activity/ies
SESSION
The ME-WE primary prevention intervention was developed by refining the existing DNA-V protocol [Participants of clusters allocated to the ME-WE intervention arm attended seven weekly 2 h group sessions, with a follow-up meeting after 3 months from the end of the intervention. Groups were comprised of 2 to 9 AYCs (with...
PMC10049644
2.3. Ethics Approval and Informed Consent
The study protocol and related documentation were assessed and approved/expert opinions were provided (in accordance with national legislation) by competent ethics committees in each of the six countries during 2019. All participants were engaged in the study on a voluntary basis in accordance with the Declaration of H...
PMC10049644
2.4. Sample
During the study protocol preparation, we conducted an average sample size estimation for each country (considering the cluster-level randomisation) [The minimum total sample sizes obtained from this procedure were as follows (
PMC10049644
2.5. Inclusion and Exclusion Criteria
a disability
RECRUITMENT
To be eligible for the study, the following inclusion criteria were established: (1) aged between 15 and 17 years at the recruitment stage; (2) caring for family member(s) (e.g., parents, siblings, grandparents) or significant other(s) (e.g., friends, schoolmates or neighbours) with a disability, chronic physical and/o...
PMC10049644
2.6. Compassionate Cases
RECRUITMENT
All participating countries allowed participants who did not meet the inclusion criteria to attend the ME-WE groups. They were identified as AYCs during recruitment and were interested in participating in the intervention. They expressed a need for support, but no alternatives for support other than the ME-WE-groups we...
PMC10049644
2.7. Recruitment
RECRUITMENT
The recruitment of AYCs was carried out between April 2019 and September 2020. All countries employed cluster-targeted recruitment methods aimed to reach a convenience sample. The efforts were invested to overcome the known difficulties to reach and involve AYCs, especially in countries where there is no formal recogni...
PMC10049644
2.8. Adaptation of Study Protocols
The COVID-19 pandemic posed (from March 2020 onwards) considerable challenges to the trial study in all six countries. Largely due to ethical considerations put forward by the project’s International Advisory and Ethics Board (IAEB), namely the possibility to continue to offer support to AYCs during the pandemic via th...
PMC10049644
2.9. CONSORT Flowchart
The Consolidated Standard of Reporting Trials (CONSORT) 2010 statement extended to cluster trials was followed in this study [
PMC10049644
3. Results
PMC10049644
3.1. Recruitment Process in the Six Countries
RECRUITMENT
There were considerable difficulties in recruiting AYCs to the trial. Below, we present a summary of recruitment efforts and outcomes for each country.
PMC10049644
3.1.1. Italy
RECRUITMENT
Initially, in Italy, researchers attempted to recruit AYCs in high schools and municipalities but without success, due to the low level of visibility of AYCs. Thus, it was decided to try to engage AYCs with the mediation of public or private health and/or social care services and through condition-specific associations...
PMC10049644
3.1.2. The Netherlands
RECRUITMENT
In the Netherlands, the recruitment was carried out through schools and care support centres. The first wave of recruitment involved the following: (a) A total of nine schools (three high schools and six schools in vocational education) entered the study, of which six schools in vocational education cancelled participa...
PMC10049644
3.1.3. Slovenia
disability
RECRUITMENT
In Slovenia, the recruitment strategy was built on liaising with high schools as well as with non-governmental organisations and care services dedicated to the disability and mental health fields concerning young people and adults. The majority of the recruitment was carried out via school presentations and direct recr...
PMC10049644
3.1.4. Sweden
RECRUITMENT
In Sweden, a school campaign was conducted, which reached out to 1081 students and 354 school staff in twelve schools. In the first intervention wave, Sweden adopted a blended delivery approach. In the second wave, with COVID-19 restrictions underway, all recruitment was conducted via advertisements and videos on socia...
PMC10049644
3.1.5. Switzerland
RECRUITMENT, RECRUITMENT
In Switzerland, recruitment was initially entirely and directly through schools. Recruitment was expanded in December 2019, and whilst it continued through the schools (with additional direct recruitment on school campuses), recruitment also took place through a wider range of additional stakeholders from the health an...
PMC10049644
3.1.6. United Kingdom
STRUCK, RECRUITMENT
In the UK, there were two waves of recruitment. In the first wave, Carers Trust (a UK-based charity) led the recruitment of the young carers projects to the study through its network of young carers support services. Carers Trust sent out informational leaflets to its network of hundreds of young carers projects across...
PMC10049644
3.2. Recruitment Results
RECRUITMENT
There were considerable differences in recruitment outcomes across countries. A large number of screen failures (young people who, among those screened, did not match with the screening criteria) are noted in the Netherlands and Slovenia, and these countries, together with Sweden, also recorded a prominent number of wi...
PMC10049644
3.3. Target Sample Size vs. Final Sample Size: Challenges
RECRUITMENT
Due to difficulties in the recruitment process, recruitment to the control groups was often delayed and thus they contain a smaller number of AYCs than the intervention group/s. Additionally, the amount of reported data from the control groups differs between the countries, making a comparison more difficult. As can be...
PMC10049644
3.4. Mitigation Measures Implemented
RECRUITMENT
Project partners implemented several measures along the recruitment process, aimed at mitigating the abovementioned challenges and the risk of involving too few participants: Extra efforts in communication activities: All partners implemented additional communication activities to reach-out to a larger number of potent...
PMC10049644
4. Discussion
RECRUITMENT
The recruitment of participants for the ME-WE trial study has certainly proved that AYCs are a hard-to-reach target group for researchers and practitioners. A lower number of participants were recruited and fully engaged, despite the significant recruitment efforts that were made and additional efforts spent. In order ...
PMC10049644
5. Conclusions
influencer, ’ interests
EVENT, RECRUITMENT
Drawing from the lessons learned from the recruitment process in our study and inputs received by stakeholders during the project (the IAEB and the Eurocarers Young Carers Working Group), we developed a set of recommendations and practical suggestions for researchers and practitioners dealing with AYCs, which may help ...
PMC10049644
Author Contributions
Conceptualisation, E.H., L.M., F.B., L.B., G.C. and V.H.; methodology, G.C., L.B., E.H., L.M. and V.H.; validation, G.C., L.B., E.H., L.M. and V.H.; formal analysis, E.H., L.M., F.B., L.B., G.C. and V.H.; investigation, E.H., L.B., G.C., V.H., I.B., F.L., R.H., R.B., S.S., M.S., B.D., Y.d.J., T.B., N.d.J., A.L., D.P., ...
PMC10049644
Institutional Review Board Statement
This study was conducted in accordance with the Declaration of Helsinki. Formal ethics approvals (and amendments, due to COVID-19 insurgence) were obtained from the ethical review boards of the University of Bologna (Italy) (116994; 144521), University of Ljubljana (Slovenia) (20 August 2019; 20 April 2020; 20 August 2...
PMC10049644
Informed Consent Statement
Written informed consent was obtained from all subjects involved in the clinical study.
PMC10049644
Data Availability Statement
The ME-WE project reports, deliverables and outputs are publicly accessible in the project website:
PMC10049644
Conflicts of Interest
The authors declare no conflict of interest.
PMC10049644
References
RECRUITMENT
CONSORT flow diagram for the original study protocol.Minimum composition of the national sample size (initial estimation).Recruitment of participants to the ME-WE trial for each partner country.* Total number of young persons who applied to the study and were screened. This number includes participants with informed co...
PMC10049644
Background
BTV
Mechanical ventilation during general anesthesia may impair airway mucosal function. This study aimed to investigate the effect of pressure-controlled ventilation-volume guaranteed (PCV-VG) on bronchial mucus transport velocity (BTV) in patients during laparoscopic surgery for gynecological oncology compared with volum...
PMC10658982
Methods
PNEUMOPERITONEUM
66 patients undergoing elective a laparoscopic surgery for gynecological oncology. The patients were randomized into two group receiving either PCV-VG or VCV. a drop of methylene blue was placed on the surface of the airway mucosa under the bronchoscopeand, then the distance the dye movement was measured after 2, 4, an...
PMC10658982
Results
64 patients were included in the analysis. The median [interquartile range] BTV was significantly lower in VCV group at T1 and T2 that at T0 (
PMC10658982
Conclusions
PCV-VG
PCV-VG is more suitable for patients undergoing laparoscopic surgery for gynecological oncology than VCV since it can protect mucociliary clearance function.
PMC10658982
Trial registration
This trial is registered on
PMC10658982
Keywords
PMC10658982
Background
Airway mucosa is the most important natural defense system in the body and is considered the first line of defense of the respiratory system [Pressure-controlled ventilation-volume guaranteed (PCV-VG) mode utilizes a decelerating flow and constant pressure to achieve volume control and pressure control. It has thus bee...
PMC10658982
Methods
PMC10658982
Study design
This was a single-center, prospective, patient and observer-blinded, randomized- controlled trial. This study was reported following the CONSORT reporting guidelines [
PMC10658982
Study population
atopy, tumor
RESPIRATORY DISEASE, MAY, TUMOR, ATOPY
First, all patients scheduled to undergo elective laparoscopic gynecologic tumor resection at the First Affiliated Hospital of Medical College, Shihezi University, China, from 12 October 2022 to 13 May 2023, were recruited. Next, only patients aged 40–75 years and met the American Society of Anesthesiologists’ (ASA) ph...
PMC10658982
Anesthesia procedures
patients-Dash
MUSCLE RELAXATION
The patients were not administered preoperative medications. Electrocardiogram, pulse oximetry, non-invasive blood pressure, and Bispectral Index Sensor (BIS, Aspect Medical Systems, Newton, MA, USA) were used to monitor all patients-Dash 3000 monitor, GE Company, Madison, USA. Anesthesia was induced using a bolus cont...
PMC10658982
Study intervention
PNEUMOPERITONEUM
The patients received ventilation using the same type of Anesthesia Machine (Datex-Ohmeda-Avance CS2, GE Company, Madison, USA) after induction of anesthesia and intubation. Anesthesia machine parameters were similar under the two modes (VT; 8 ml /kg, inspiratory/expiratory ratio (I/E); 1:2, positive end-expiratory pre...
PMC10658982
Measurements
BTV
SECONDARY, PNEUMOPERITONEUM
The respiratory circuit was disconnected at T0, T1, and T2 time points as described by Seo H and Kim SH et al. [Method for measuring bronchial mucus transport velocity (BTV). Data were collected at the following time points:Baseline; 5 min after endotracheal intubation and before initiation of the pneumoperitoneum (T0)...
PMC10658982
Sample size
PASS 15 Power Analysis and Sample Size Software (2017NCSS, LLC. Kaysville, Utah, USA) was used to determine the minimum number of samples. For BTV, a minimum number of 16 patients per group was required to detect a difference of at least 5.0 mm/min with a two-tailed alpha error of 0.05 and desired power of 80% (accordi...
PMC10658982
Randomization and blinding
PCV-VG
The 66 subjects were divided into two groups (1:1) using SPSS 26.0 software program (IBM SPSS Statistics, Chicago, Illinois, USA). and computer random number method. 33 pairs of numbers (1 or 2) were randomly generated, where 1 and 2 corresponded to the PCV-VG and VCV groups, respectively. The intervention methods adop...
PMC10658982
Statistical analyses
cancer
CANCER, PNEUMOPERITONEUM
Normal distribution of data was assessed using the Shapiro-Wilktest test. The equality of group variances was evaluated using the homogeneity of variance test (Levene statistic). Two independent samples t-tests were used to analyze data for age, height, BMI, weight, anesthesia time, pneumoperitoneum time, forced expira...
PMC10658982
Discussion
BTV, throat
PNEUMOPERITONEUM
In this study, both VCV and PCV-VG ventilation modes inhibited BTV in patients during laparoscopic surgery for gynecological oncology, and the degree of inhibition increased with increasing pneumoperitoneum time. The degree of BTV inhibition was not significantly different between the two groups at 1 h after pneumoperi...
PMC10658982
Acknowledgements
We would like to express our sincere gratitude to all the participants for theirsupport and contribution to this research. We greatly appreciate the assistancefrom all the surgical and operating room members of First Affiliated Hospital, Shihezi University for their support in conducting this study.
PMC10658982
Authors’ contributions
Chao Deng and Tao Xu developed the concept and drafted the manuscript; Chao Deng and XK Wang performed the experiments and data acquisition; DF Gu contributed to the literature research and data analysis; T Xu revised the manuscript. All have read the final version of this paper and have agreed with this submission.
PMC10658982
Funding
This research was conducted with financial support from a research scholarship supported though funding from Science and Technology Bureau (No.2022ZD037).
PMC10658982
Availability of data and materials
The datasets used and analyzed during the current study are available from the corresponding author on request.
PMC10658982
Declarations
PMC10658982
Ethics approval and consent to participate
This study was approved by the Research Ethics Board of The First Affiliated Hospital of Shihezi University School of Medicine (Shihezi, China) and is registered on
PMC10658982
Consent for publication
Not applicable.
PMC10658982
Competing interests
The authors declare no competing interests.
PMC10658982
References
PMC10658982
Abstract
PMC10109340
Objective
MULTIPLE SCLEROSIS (MS)
This study aimed to evaluate safety (infusion‐related reactions [IRRs]) and patient satisfaction (patient‐reported outcomes [PROs]) for at‐home ocrelizumab administration for patients with multiple sclerosis (MS).
PMC10109340
Methods
ADVERSE EVENTS, DISEASE
This open‐label study included adult patients with an MS diagnosis who had completed a ≥ 600‐mg ocrelizumab dose, had a patient‐determined disease steps score of 0 to 6 and had completed PROs. Eligible patients received a 600‐mg ocrelizumab home‐based infusion over 2 h, followed by 24‐h and 2‐week post‐infusion follow‐...
PMC10109340
Results
fatigue, grogginess, itch, mild/moderate
Overall, 99 of 100 expected patients were included (mean [SD] age, 42.3 [7.7] years; 72.7% female; 91.9% White). The mean (SD) infusion time was 2.5 (0.6) hours, and 75.8% of patients completed their ocrelizumab infusion between 2 to 2.5 h. The IRR incidence rate was 25.3% (95% CI: 16.7%, 33.8%)—similar to other shorte...
PMC10109340
Interpretation
IRRs and AEs occurred at acceptable rates during in‐home infusions of ocrelizumab over a shorter infusion time. Patients reported increased confidence and comfort with the home infusion process. Findings from this study provide evidence of the safety and feasibility of home‐based ocrelizumab infusion over a shorter inf...
PMC10109340
Introduction
MULTIPLE SCLEROSIS (MS), DISEASE
Treatment for multiple sclerosis (MS) often requires routine and long‐term care for optimal disease management, including the administration of disease‐modifying therapies (DMTs) by intravenous (IV) infusion.Ocrelizumab is a recombinant, humanized monoclonal antibody that selectively targets CD20‐expressing B cells and...
PMC10109340
Methods
PMC10109340
Trial design
ADVERSE EVENT, RECRUITMENT
This was an open‐label, single‐arm, nonrandomized study to evaluate the safety and patient experience of ocrelizumab infusion over a 2‐h period via home‐based infusion (NCT04650321). The similarly designed Phase IIIb, open‐label SaROD study of accelerated ocrelizumab infusions was used as a historical control.Eligible ...
PMC10109340
Patient population
In this study, participant selection was designed to reflect real‐world patients with MS who receive ocrelizumab. Enrollment occurred on a rolling basis over a 12‐month period from active patients of the Rocky Mountain MS Center (RMMSC) at the University of Colorado Anschutz Medical Campus until the target population o...
PMC10109340
Outcome measures
Cancer
ADVERSE EVENT, DISEASE, DISEASE CHARACTERISTIC, APPENDIX, CANCER
Data collected at screening and pre‐infusion visits consisted of patient demographics (age, sex, race, and ethnicity) and clinical disease characteristics (type of MS, disease duration, DMT type, DMT duration, PDDS score, and number of prior ocrelizumab infusions). Infusion procedure variables documented during the inf...
PMC10109340
Statistical analysis
DISEASE CHARACTERISTIC
Descriptive statistics were used to summarize patient demographics, clinical disease characteristics, infusion procedure variables and AEs for the ITT population. Controls were limited to available historic data from the SaROD study.The frequencies and proportions of IRRs for the primary outcome were summarized descrip...
PMC10109340
Results
PMC10109340
Patient demographics and disease characteristics
RRMS
DISEASE, MULTIPLE SCLEROSIS, DISEASE CHARACTERISTIC
Between August 2020 and February 2021 medical charts were reviewed for 925 eligible patients with MS, and 312 patients were contacted by the study team (Fig. Patient identification and attrition.A total of 99 patients with MS were included in the ITT population in this home infusion cohort study. The mean (SD, range) a...
PMC10109340
Summary of at‐home ocrelizumab infusion procedures
The majority of patients received acetaminophen (94.9%), methylprednisolone (89.9%) and diphenhydramine (88.9%) prior to their ocrelizumab infusion (Table Infusion procedure by study cohort.One patient switched to 25 mg of diphenhydramine due to a prior reaction with the 50‐mg dose.Longer infusion times may have been a...
PMC10109340
Overall, only 25.3% (95% CI: 16.7%, 33.8%) of patients experienced an IRR of any grade during the at‐home ocrelizumab infusion. These IRRs were 18.2% Grade 1 (95% CI: 10.6%, 25.8%) and 7.1% Grade 2 (95% CI: 2.9%, 14.0%); no IRRs were classified as ≥Grade 3 (95% CI: 0.0%, 3.7%) (Fig. Frequency of infusion‐related reacti...
PMC10109340
Patient‐reported
ADVERSE EVENT
Among these patients, a total of 174 AEs were reported, and 66.7% of patients experienced an AE with at‐home ocrelizumab infusion (Fig. Post‐infusion (A) patient‐reported AEs and (B) most common patient‐reported AEs. AE, adverse event; GI gastrointestinal.
PMC10109340
Patient experience with home‐based ocrelizumab treatment
Patients reported favorable scores across PRO measures of their at‐home infusion experience, compared to their prior infusion experience at an infusion center. Significant improvements from were reported following a home for overall experience with the at‐home infusion process (The (A) overall patient experience with o...
PMC10109340
Discussion
DISEASE, RECRUITMENT
This open‐label, single‐arm, nonrandomized study is among the first to assess the safety of the at‐home infusion of ocrelizumab. Leveraging the shorter infusion regimen, at‐home administration did not increase the incidence of IRRs compared with the SaROD trial of the shorter infusion protocol for administering ocreliz...
PMC10109340
Author Contributions
PMC10109340
Conflict of Interest Statement
PMC10109340
Funding Information
INTERACTIONS
NIH funding was provided by CTSA grants UL1 TR002535, KL2 TR002534, and TLI TR002533. This study was sponsored by F. Hoffmann‐La Roche Ltd and Genentech, Inc. Support for third‐party writing assistance, furnished by Charli Dominguez, PhD, CMPP, of Health Interactions, Inc, was provided by F. Hoffmann‐La Roche Ltd.
PMC10109340
Supporting information
Click here for additional data file.
PMC10109340
Acknowledgements
We thank the patients and their families who participated in this study. We also acknowledge the Adult Clinical and Translational Research Center (CTRC) Nursing services at the Colorado Clinical and Translational Sciences Institute (CCTSI).
PMC10109340
Data Availability Statement
The datasets generated and/or analyzed during the current study are not publicly available as this study involved the merging of data from several different sources (patient‐reported outcomes, laboratory outcomes, telehealth visit data) and different electronic systems (home infusion center, academic medical center) bu...
PMC10109340
References
PMC10109340
Background
Cell salvage reduces allogenic blood transfusion requirements in surgery. We present a pilot study exploring the impact of anticoagulant choice, citrate or heparin, on the quality of cell salvaged blood in adults undergoing coronary artery bypass grafting (CABG).
PMC10082980
Materials and methods
inflammation
INFLAMMATION
Elective on pump CABG patients were randomly allocated to citrate or heparin anticoagulation. We measured red blood cell characteristics and inflammation in both the blood collection reservoir and the washed red blood cell concentrate. Postoperatively, the level of biomarkers and the coagulation profile in the peripher...
PMC10082980
Results
Thirty eight patients were included, 19 in the citrate group and 19 in the heparin group. Baseline characteristics were similar. In the washed red blood cell concentrate, Mean Hb (g/dl) and Ht (%) were lower in the citrate group [Hb: 18.1 g/dL (SD 1.3) vs. 21.1 (1.6),
PMC10082980
Supplementary Information
The online version contains supplementary material available at 10.1186/s13019-023-02246-w.
PMC10082980
Keywords
PMC10082980
Background
blood loss
BLOOD LOSS, ADVERSE EFFECTS, BLOOD
Allogenic blood transfusion, a necessary tool in managing perioperative blood loss, has several adverse effects. Perioperative allogenic blood transfusion, even when limited in volume, is associated with postoperative morbidity, increased length of stay and so cost, and mortality in both general and cardiac surgery [Bl...
PMC10082980
Methods
intraoperative bleeding, blood loss, neoplasia, infection, hemolysis
BLOOD LOSS, NEOPLASIA, CHRONIC INFLAMMATORY DISEASE, INFECTION, BLOOD, HEMOLYSIS, INTRAOPERATIVE BLEEDING
This single center pilot study (NCT02674906) was performed in the operating room and the mixed medical-surgical ICU of Ziekenhuis Oost Limburg (ZOL), Genk, Belgium, a 805-bed non-university teaching hospital. This study was approved by the local ethics committee and written informed consent was obtained prior to surger...
PMC10082980
Results
Over a 3 month study period, a total of 38 patients were included, 19 patients in each group. There were no significant differences in baseline characteristics, including fasting lipid profiles, between the groups, apart from a higher lymphocyte count in the citrate exposed patients (of citrate group) (Table Panel A. B...
PMC10082980
The quality of WRBC
WRBC from patients in the citrate group had lower Hb, Ht and RBC count compared to heparin exposed patients (Table WBC counts did not differ between groups in WRBC. WBC differentiation showed a higher count and percentage for lymphocytes, monocytes and eosinophils in the citrate group (see Table
PMC10082980
Inflammatory parameters
In the BCR, despite no difference at baseline, the anti-inflammatory marker IL-10 was significantly higher in the citrate group [203.70 (108.98–411.42) vs 108.10 (60.00–176.71) Before WRBC transfusion, there were no significant differences in inflammatory parameters between the groups (see Additional file Results in pa...
PMC10082980
The impact after transfusion of WRBC
Free Hb, iron, ferritin, haptoglobin and hepcidin did not differ between the groups, both before and after WRBC transfusion. There was no difference in aPTT, PT, INR and ROTEM analysis before and after WRBC transfusion between groups. Both intra-operatively and post-operatively there was no difference between the group...
PMC10082980
Cell salvage volumes
There were no significant differences between study groups in total fluid volume collected in BCR, ATBR, incubation time, waste fluid and washing fluid. Although the volume of WRBC was higher in the citrate group this difference was not significant. The significant difference in Ht in WRBC between groups (see Table No ...
PMC10082980
Discussion
blood loss, hemolysis, postoperative bleeding
HYPOTONIC, BLOOD LOSS, POSTOPERATIVE BLEEDING, FRAGILITY, BLOOD, HEMOLYSIS, INFLAMMATORY RESPONSE
In this trial comparing the effects of differing anticoagulant regimens (citrate or heparin) on cell salvage in adult patients undergoing elective pump CABG, small but relevant differences were observed between the two groups. WRBC had a significantly lower hematocrit and higher MCV and a larger residual thrombocyte co...
PMC10082980
Conclusion
BLOOD, RESIDUAL
This study comparing citrate vs. heparin in cell salvage in adults undergoing coronary artery bypass grafting (CABG) found significant differences in the washed red blood cell concentrates: Hb and Hct were lower in the citrate group and the washed red blood cells had a higher MCV and lower MCHC. Residual trombocyte cou...
PMC10082980
Author contributions
MVT
WB: Conception and design of the study; the acquisition of data and data analysis, interpretation of data; drafting of and substantive revision of the manuscript. MVT: Design of study, the acquisition of data and data analysis; drafting of and substantive revision of the manuscript. MB: Design of study, the acquisition...
PMC10082980
Funding
None.
PMC10082980
Availability of data and materials
The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.
PMC10082980
Declarations
PMC10082980
Ethics approval and consent to participate
The study protocol was approved by the local institutional review board (Commissie Medische Ethiek, Ziekenhuis Oost‐Limburg, approval. Written informed consent to participate in the study was obtained prior to surgery from the patient or legal representative.
PMC10082980