Maroeska M Rovers's research while affiliated with Radboud University Medical Centre (Radboudumc) and other places
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Publications (516)
Background
Despite increasing use for gastric cancer surgery, it is unclear how robot-assisted minimally invasive gastrectomy (RAMIG) has been evaluated. This study assessed how RAMIG was evaluated using the IDEAL-framework (1=Idea, 2A=Development, 2B=Exploration, 3=Assessment, 4=Long-term follow-up) during its implementation and reviewed its curre...
Background:
Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. It may cause hearing loss which, when persistent, may lead to developmental delay, social difficulty and poor quality of life. Management includes watchful waiting, autoinflation, medical and surgical treatment. Inserti...
Background:
Acute otitis media (AOM) is one of the most common diseases in childhood for which antibiotics are commonly prescribed; a systematic review reported a pooled prevalence of 85.6% in high-income countries. This is an update of a Cochrane Review first published in the Cochrane Library in 1997 and updated in 1999, 2005, 2009, 2013 and 2015...
BACKGROUND
Laser interstitial thermal therapy (LITT) is growing as a minimally invasive procedure in the treatment of brain tumours, even if high-quality evidence is lacking. We aimed to assess practical feasibility of a randomized controlled trial (RCT) in patients with primary irresectable glioblastoma (nGBM) and to collect pilot data on technica...
![Inclusion flowchart. * refers to Young et al. [7], ** refers to...](publication/373681462/figure/fig1/AS:11431281206076333@1700559535978/Inclusion-flowchart-refers-to-Young-et-al-7-refers-to-Lemiengre-et-al-6-and_Q320.jpg)
Background
A previous individual participant data meta-analysis (IPD-MA) of antibiotics for adults with clinically diagnosed acute rhinosinusitis (ARS) showed a marginal overall effect of antibiotics, but was unable to identify patients that are most likely to benefit from antibiotics when applying conventional (i.e. univariable or one-variable-at-...
Introduction
Minimally Invasive transCervical Esophagectomy (MICE) is a novel transcervical approach to esophagectomy with the possible advantage of decreased pulmonary complications. MICE is in an early stage of introduction in patients which are treated with the McKeown procedure in regular practice. The aim of this study was to provide insight i...
Background
Glioblastoma (GBM) is the most common primary, malignant brain tumour with a 5-year survival of 5%. If possible, a glioblastoma is resected and further treated with chemoradiation therapy (CRT), but resection is not feasible in about 30% of cases. Current standard of care in these cases is a biopsy followed by CRT. Magnetic resonance (MR...
Purpose
Laser interstitial thermal therapy (LITT) is increasingly being used in the treatment of brain tumors, whereas high-quality evidence of its effectiveness is lacking. This pilot examined the feasibility of conducting a randomized controlled trial (RCT) in patients with irresectable newly diagnosed glioblastoma (nGBM), and generated data on t...
Objective
Acute and chronic tonsillitis are frequently treated with antibiotics. This study aimed to understand the presence of pathogenic micro-organisms on the surface and core of chronically infected tonsils among Tanzanian children.
Methods
The study enrolled children undergoing adenotonsillectomy. Surface and core tonsillar swabs were taken....
The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These in...
Introduction:
In the last decades, the application of stereotactic laser ablation (SLA) for the treatment of intracranial tumours has been growing, even though comparative trials are lacking. Our aim was to investigate the familiarity with SLA of neurosurgeons in Europe and their opinion regarding potential neuro-oncological indications. Furthermo...
Background:
Unnecessary and inappropriate antibiotic use is an increasing global health challenge. in limited resource settings, Prophylactic antibiotics are still often used in (adeno)tonsillectomy ((A)TE), despite evidence against their effectiveness. This study aimed to investigate the effect of prophylactic amoxicillin, given after (A)TE in ch...
Background
Stakeholder engagement in evaluation of medical devices is crucial for aligning devices with stakeholders’ views, needs, and values. Methods for these engagements have however not been compared to analyse their relative merits for medical device evaluation. Therefore, we systematically compared these three methods in terms of themes, int...
Objective:
The aim of this study was to determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia formation in the long-term.
Background:
A PSH is the most frequent complication after stoma formation. Prophylactic placement of a mesh has been suggested to prevent parastomal hernia,...
Aims
Numerous studies have shown that arthroscopic partial meniscectomy (APM) is not (cost-) effective in patients with symptoms attributed to a degenerative meniscus tear. We aimed to assess the budget impact of reducing APM in routine clinical practice in this population.
Materials and methods
A patient-level state transition model was developed...
Objective
To identify subgroups of patients with MRI-confirmed degenerative meniscus tears who may benefit from arthroscopic partial meniscectomy (APM) in comparison with non-surgical or sham treatment.
Methods
Individual participant data (IPD) from four RCTs were pooled (605 patients, mean age: 55 (SD: 7.5), 52.4% female) as to investigate the ef...
Introduction
Stakeholder involvement in medical device development draws much attention. To make well-considered methodological choices while involving stakeholders, it is essential to know what approaches are available and what challenges they bring in practice. Therefore, the aim of this review was to study which participatory approaches are used...
Introduction
Multi-stakeholder engagement in the development and evaluation of medical devices is crucial for aligning devices with stakeholders’ views, needs, and values. Focus groups, interviews, and surveys are often used to involve stakeholders, but these methods have rarely been compared to analyse their relative merits. Therefore, we systemat...
Introduction
In early stages, the consequences of innovations are often unknown or deeply uncertain. This complicates health economic modelling. The field of decision-making under deep uncertainty (DMDU) uses exploratory modelling (EM) to help decision-makers make sound decisions under conditions of deep uncertainty (i.e., when stakeholders do not...
PurposeNavigation has been suggested to guide complex benign bone tumor curettage procedures, but the contribution of navigation to the accuracy of curettage has never been quantified. We explored the accuracy of navigated curettage in a cadaveric observational pilot study, comparing navigated to freehand curettage, performed independently by an ex...
Objectives:
In early stages, the consequences of innovations are often unknown or deeply uncertain, which complicates early health economic modeling (EHEM). The field of decision making under deep uncertainty uses exploratory modeling (EM) in situations when the system model, input probabilities/distributions, and consequences are unknown or debat...
Background:
There is a wide variety of participatory approaches to involve stakeholders in the development of medical devices, but there is no comprehensive overview of these approaches. We therefore studied what participatory approaches are used in the development of medical devices as well as the most important characteristics and challenges of...
Objectives
To determine if cone beam CT-guided navigation bronchoscopy (CBCT-NB) is a cost-effective diagnostic procedure in patients with a pulmonary nodule (PN) with an intermediate risk for lung cancer.
Materials and methods
Two decision analytical models were developed to compare the long-term costs, survival and quality of life. In the first...
Background
In patients with spontaneous supratentorial intracerebral hemorrhage (ICH), open craniotomy has failed to improve a functional outcome. Innovative minimally invasive neurosurgery (MIS) may improve a health outcome and reduce healthcare costs.AimsBefore starting phase-III trials, we aim to assess conditions that need to be met to reach th...
Background
The utilisation of robot-assisted radical cystectomy with intracorporeal reconstruction (iRARC) has increased in recent years. Little is known about the length of the learning curve (LC) for this procedure.
Objective
To study the length of the LC for iRARC in terms of 90-d major complications (MC90; Clavien-Dindo grade ≥3), 90-d overall...
Background and aim
Transthoracic minimally invasive oesophagectomy (MIO) is increasingly performed as part of curative multimodality treatment. There is no robust evidence on the preferred location of the anastomosis after transthoracic MIO. The aim of this study was to compare an intrathoracic with a cervical anastomosis in a randomised controlled...
Background
The shift from open to minimally invasive procedures with growing complexity has increased the demand for advanced intraoperative medical technologies. The hybrid operating room (OR) combines the functionality of a standard OR with fixed advanced imaging systems to facilitate minimally invasive image-guided procedures.
Objective
This sy...
Objective
To develop a prioritisation framework to support priority setting for elective surgeries after COVID-19 based on the impact on patient well-being and cost.
Design
We developed decision analytical models to estimate the consequences of delayed elective surgical procedures (eg, total hip replacement, bariatric surgery or septoplasty).
Set...
Background
Health systems face challenges to accelerate access to innovations that add value and avoid those unlikely to do so. This is very timely to the field of age-related sensorineural hearing loss (ARHL), where a significant unmet market need has been identified and sizeable investments made to promote the development of novel hearing therape...
Objectives
To adjust for confounding in observational data, researchers use propensity score matching (PSM), but more advanced methods might be required when dealing with longitudinal data and time-varying treatments as PSM might not include possible changes that occurred over time. This study aims to explore which confounding adjustment methods ha...
Purpose
To develop a diagnostic model to identify patients at high risk of a CPA lesion.
Methods
A consecutive cohort of patients with AAD referred by a general practitioner, who underwent their first MRI examination of the CPA between 2005 and 2015 was included. Demographics, symptoms, findings during physical examination, and pure-tone audiometr...
Background
Modelling non-linear associations between an outcome and continuous patient characteristics, whilst investigating heterogeneous treatment effects, is one of the opportunities offered by individual participant data meta-analysis (IPD-MA). Splines offer great flexibility, but guidance is lacking.
Objective
To introduce modelling of nonlin...
Background
Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient. No randomised controlled trials on the efficacy of ESS have been published. We aimed to assess the efficacy of ESS plus medical therapy versus medical therapy alone in patien...
Aim
To determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term.
Material and Methods
In this multicenter superiority trial patients undergoing formation of a permanent colostomy were randomly assigned to either retromuscular mesh reinforcement or con...
Objectives
To determine the cost-effectiveness of auditory brainstem response prior to MRI (ABR-MRI) compared to standalone MRI to diagnose vestibular schwannoma.
Design
A state transition model was developed to simulate costs and effects (quality-adjusted life years (QALY)) for both diagnostic strategies for patients suspected of a vestibular sch...
Background
The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5–30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery....
Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer.
Methods
In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer p...
Context:
Focal therapy is a promising, minimally invasive strategy to selectively treat localized prostate cancer. A previous systematic review indicated that there is growing evidence for favorable functional outcomes, but that oncological effectiveness was yet to be defined.
Objective:
To assess the effectiveness of focal therapy in patients w...
Randomized trials typically estimate average relative treatment effects, but decisions on the benefit of a treatment are possibly better informed by more individualized predictions of the absolute treatment effect. In case of a binary outcome, these predictions of absolute individualized treatment effect require knowledge of the individual's risk w...
Objectives
Involving end-users and patients in the development of surgical devices, even when patients are not end-users, is deemed important in policy and in academia since it could improve strategic choices in research and development (R&D). Nonetheless, research into innovators’ views on end-user and patient involvement is rare. This study explo...
Objectives: To determine the cost-effectiveness of auditory brainstem response prior to MRI (ABR-MRI) compared to standalone MRI to diagnose vestibular schwannoma. Design: A state transition decision-analytic model was developed to simulate costs and effects (quality-adjusted life years) for both treatment strategies for patients suspected of a ves...
Objective:
To develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations.
Summary background data:
Nearly all medical products which do not work solely through chemical action are regulated as medical devices. Their huge range of purposes, mechanisms of action and r...
Introduction
Acute rhinosinusitis (ARS) is a prime reason for doctor visits and among the conditions with highest antibiotic overprescribing rates in adults. To reduce inappropriate prescribing, we aim to predict the absolute benefit of antibiotic treatment for individual adult patients with ARS by applying multivariable risk prediction methods to...
Randomized trials typically estimate average relative treatment effects, but decisions on the benefit of a treatment are possibly better informed by more individualized predictions of the absolute treatment effect. In case of a binary outcome, these predictions of absolute individualized treatment effect require knowledge of the individual's risk w...
Background:
Open radical cystectomy (ORC) is regarded as the standard treatment for muscle-invasive bladder cancer, but robot-assisted radical cystectomy (RARC) is increasingly used in practice. A recent study showed that RARC resulted in slightly fewer minor but slightly more major complications, although the difference was not statistically sign...
Background
Transthoracic minimally invasive esophagectomy (MIE) is increasingly performed as part of curative multimodality treatment. There appears to be no robust evidence on the preferred location of the anastomosis after transthoracic MIE.
Objective
To compare an intrathoracic with a cervical anastomosis in a randomized clinical trial.
Design...
Objective:
To extend the IDEAL Framework for device innovation, IDEAL-D, to include the preclinical stage of development (Stage 0).
Background:
In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should...
Inadequate margins continue to occur frequently in patients who undergo surgical resection of a tumor, suggesting that current intraoperative methods are not sufficiently reliable in determining the margin status. This clinical demand has inspired the development of many novel imaging techniques that could help surgeons with intraoperative margin a...
Objectives
The main objective of this review was to map how decision analytic models are used in surgical innovation (in which research phase, with what aim) and to understand how challenges related to the assessment of surgical interventions are incorporated.
Methods
We systematically searched PubMed, Embase, and the Cochrane Library for studies...
Objectives
To develop an interactive tool that estimates what potential benefits are needed for the robot to provide value for money when compared with endoscopic or open surgical interventions.
Design
A generic online interactive tool was developed to analyze the (health) effects needed to compensate for the additional costs of using a surgical r...
Objective
To assess the cost-effectiveness of sentinel lymph node mapping compared to risk factor assessment and routine full lymph node dissection for the assessment of lymph nodes in patients with low- and intermediate-risk endometrioid endometrial cancer.
Methods
A decision-analytic model was designed to compare three lymph node assessment stra...
Background:
Laser interstitial thermal therapy (LITT) is a minimal invasive neurosurgical technique for the treatment of brain tumors. Results of LITT have been reported in a case series of patients with deep seated and/or recurrent glioblastoma or cerebral metastases. With this review we aim to summarize the currently available evidence regarding...
Background
Radical cystectomy with pelvic lymph node dissection (PLND) and urinary diversion in patients with bladder cancer is known for its high risk of complications. Although open radical cystectomy (ORC) is regarded as the standard treatment, robot-assisted radical cystectomy (RARC) is increasingly used in practice, despite the fact that high-...
Objectives:
To develop a prediction model to predict vestibular schwannoma (VS) growth for patients in a wait and scan (W&S) strategy.
Design:
Retrospective cohort study.
Setting:
Tertiary hospital (Radboud university medical center, Nijmegen, the Netherlands).
Participants:
Patients with unilateral VS, entering a W&S strategy and at least o...
Background: Nearly all medical products which do not work solely through chemical action,
from condoms to surgical robots, are regulated as medical devices. Their huge range of
purposes, mechanisms of action and inherent risk pose unique challenges for regulation.
High-profile implantable device failures and adverse effects have fuelled concerns ab...
Objective:
To construct an early health economic model to assess the potential added value of novel hearing therapeutics, compared with the current standard of care. We use idiopathic sudden sensorineural hearing loss (ISSNHL) as a case example, because it is a lead indication for several emerging hearing therapeutics.
Methods:
A decision analyt...
Background:
Over the past decade, many hospitals have adopted hybrid operating rooms (ORs). As resources are limited, these ORs have to prove themselves in adding value. Current estimations on standard OR costs show great variety, while cost analyses of hybrid ORs are lacking. Therefore, this study aims to identify the cost drivers of a convention...
4509
Background: Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods: In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina...
Aims:
Recent studies have suggested that corticosteroid injections into the knee may harm the joint resulting in cartilage loss and possibly accelerating the progression of osteoarthritis (OA). The aim of this study was to assess whether patients with, or at risk of developing, symptomatic osteoarthritis of the knee who receive intra-articular cor...
Background:
For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actu...
Objectives
Two-thirds of patients do not harbor lymph node (LN) metastases after neoadjuvant chemoradiotherapy (nCRT). Our aim was to explore under which circumstances a selective lymph node dissection (LND) strategy, which selects patients for LND based on the restaging results after nCRT, has added value compared with standard LND in esophageal c...
Minimally invasive esophagectomy is increasingly performed for the treatment of esophageal cancer, but it is unclear whether hybrid minimally invasive esophagectomy (HMIE) or totally minimally invasive esophagectomy (TMIE) should be preferred. The objective of this study was to perform a meta-analysis of studies comparing HMIE with TMIE. A systemat...
Objective:
The effect of surgical treatment for supratentorial spontaneous intracerebral hemorrhage and whether it is modified by key baseline characteristics and timing remains uncertain.
Methods:
We performed a systematic review and meta-analysis of randomized controlled trials of surgical treatment of supratentorial spontaneous intracerebral...
Objectives
Lymph node dissection (LND) is part of the standard operating procedure in patients with resectable oesophageal cancer after neoadjuvant chemoradiotherapy regardless of lymph node (LN) status. The aims of this case vignette survey were to acquire expert opinions on the current practice of LND and to determine potential consequences of no...
Introduction
Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The...
Background:
Current intraoperative methods of visual inspection and tissue palpation by the surgeon, and frozen section analysis cannot reliably prevent inadequate surgical margins in patients treated for oral squamous-cell carcinoma (OSCC). This study assessed feasibility of MRI for the assessment of surgical resection margins in fresh OSCC speci...
The name of the co-author Wendy J. Ungar was inadvertently omitted on the original published article. Her name and affiliation have now been added to the author list.
INTRODUCTION:
Up to 32% of patients with esophageal cancer show a pathological complete response (ypCR) after neoadjuvant therapy. To prevent overtreatment, the indication to perform esophagectomy in these patients should be reconsidered. Implementing an organ-preserving strategy for patients with ypCR requires an accurate assessment of residual...