Publications by authors named "Ponten J"

Introduction: There is uncertainty regarding the optimal mesh fixation techniques for laparoscopic ventral and incisional hernia repair.

Aim: To perform a systematic review and network meta-analysis of randomised control trials (RCTs) to investigate the advantages and disadvantages associated with absorbable tacks, non-absorbable tacks, non-absorbable sutures, non-absorbable staples, absorbable synthetic glue, absorbable sutures and non-absorbable tacks, and non-absorbable sutures and non-absorbable tacks.

Methods: A systematic review was performed as per PRISMA-NMA guidelines.

View Article and Find Full Text PDF

Background: The Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) was established in 2013 with the intention of developing a coordinated mechanism between volunteering EU stakeholders and developers of Orphan Medicinal Products (OMPs) to support the exchange of information aimed at enabling informed decisions on pricing and reimbursement at Member State level and to evaluate the value of an OMP based on a Transparent Value Framework. The objective of the collaborative approach was to support more equitable access to authorised therapies for people living with rare diseases, rational prices for payers and more predictable market conditions for OMP developers. Over the past 10 years, the MoCA has conducted a series of pilot projects, examining a variety of different products and technologies at different stages of development; and with contributions from a variety of patient representatives, participation from EU payers from a range of Member States and, recently, with EUnetHTA members and the European Medicines Agency participating in the meetings as observers.

View Article and Find Full Text PDF

Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower income countries rely mainly on financial based agreements to manage uncertainties associated with new therapies. We performed a survey, an exploratory literature review and an iterative brainstorming in parallel about potential barriers and solutions to outcome-based agreements in Central and Eastern Europe (CEE) and in the Middle East (ME).

View Article and Find Full Text PDF

The need for innovative payment models for health technologies with high upfront costs has emerged due to affordability concerns across the world. Early technology adopter countries have been experimenting with delayed payment schemes. Our objective included listing potential barriers for implementing delayed payment models and recommendations on how to address these barriers in lower income countries of Central and Eastern Europe (CEE) and the Middle East (ME).

View Article and Find Full Text PDF

The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective ( = 25), and the rest are from regulatory perspective ( = 13), and transfer of knowledge point of view ( = 3).

View Article and Find Full Text PDF

As part of the HTx (Next Generation Health Technology Assessment) project, this study was aimed at identifying the main barriers for application of real-world evidence (RWE) for the purposes of health technology assessment in the Central and Eastern European countries. A mixed methods approach was employed to identify the main barriers: a scoping review of the literature and a series of discussions with stakeholders. Based on the applied approaches, we attempted to summarize the main barriers and challenges related to transferability of RWE in five main groups: technical, regulatory, clinical, scientific and perceptional barriers.

View Article and Find Full Text PDF

Background: European treatment guidelines recommend prasugrel over ticagrelor for treating patients with non-ST-elevation acute coronary syndrome (ACS), prompting several Swedish administrative regions to transition from ticagrelor to prasugrel as the preferred treatment for patients with ACS. We aim to systematically evaluate this transition to determine the relative efficacy of prasugrel versus ticagrelor in a real-world cohort of patients with ACS.

Study Design And Objectives: The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial, in which administrative regions in Sweden will constitute the clusters.

View Article and Find Full Text PDF

Purpose: There is a lack of prospective studies evaluating the effects of body composition on postoperative complications after gastrectomy in a Western population with predominantly advanced gastric cancer.

Methods: This is a prospective side study of the LOGICA trial, a multicenter randomized trial on laparoscopic versus open gastrectomy for gastric cancer. Trial patients who received preoperative chemotherapy followed by gastrectomy with an available preoperative restaging abdominal computed tomography (CT) scan were included.

View Article and Find Full Text PDF

The available evidence on relative effectiveness and risks of new health technologies is often limited at the time of health technology assessment (HTA). Additionally, a wide variety in real-world data (RWD) policies exist among HTA organizations. This study assessed which challenges, related to the increasingly complex nature of new health technologies, make the acceptance of RWD most likely.

View Article and Find Full Text PDF

Background: Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use.

Methods: This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis.

View Article and Find Full Text PDF

Over the past decades, survival rates for patients with resectable esophageal cancer have improved significantly. Consequently, the sequelae of having a gastric conduit, such as development of micronutrient deficiencies, become increasingly apparent. This study investigated postoperative micronutrient trends in the follow-up of patients following a minimally invasive esophagectomy (MIE) for cancer.

View Article and Find Full Text PDF

Objective: The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complications. Complications such as an extended operation duration, additional use of painkillers, reoperation, infection, seroma, extended wound care, extended hospitalization, and early recurrence were reported according to the Clavien-Dindo grading system.

Summary Background Data: Over the years mesh repair is proven the gold standard for umbilical and epigastric hernias.

View Article and Find Full Text PDF

Background: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics.

View Article and Find Full Text PDF

Introduction: For decades, intrathoracic stomach has been an indication for surgical repair and over time laparoscopy has become standard treatment. However, there are still many aspects in the treatment of intrathoracic stomach that are subject of debate. We performed a literature review to discuss the role of laparoscopy in intrathoracic stomach repair.

View Article and Find Full Text PDF

Design: This trial is a randomized controlled, patient-blinded, multicentre, superiority trial.

Methods: All patients ≥18 years with a single, symptomatic and primary umbilical or epigastric hernia (<2 fingers) qualified for participation in the study. Flat polypropylene mesh repair was compared to patch repair (PROCEED Ventral Patch) (PVP).

View Article and Find Full Text PDF

Background: Laparoscopic cruroplasty and fundoplication have become the gold standard in the treatment of hiatal hernia and gastro-oesophageal reflux disease (GERD). The use of a mesh-reinforcement of the cruroplasty has been proven effective; although, there is a lack of evidence considering which type of mesh is superior. The aim of this study was to compare recurrence rates after mesh reinforced cruroplasty using biological versus synthetic meshes.

View Article and Find Full Text PDF

Introduction:: Nissen fundoplication is the golden standard for surgical treatment of gastroesophageal reflux disease (GERD). Numerous studies report excellent short-term results. However, data regarding long-term quality of life are lacking.

View Article and Find Full Text PDF

Background: Diastasis of the rectus abdominis muscles (DRAM) is characterised by thinning and widening of the linea alba, combined with laxity of the ventral abdominal musculature. This causes the midline to "bulge" when intra-abdominal pressure is increased. Plastic surgery treatment for DRAM has been thoroughly evaluated, though general surgical treatments and the efficacy of physiotherapy remain elusive.

View Article and Find Full Text PDF

Background: Many patients who have surgery for acute cholecystitis receive postoperative antibiotic prophylaxis, with the intent to reduce infectious complications. There is, however, no evidence that extending antibiotics beyond a single perioperative dose is advantageous. This study aimed to determine the effect of extended antibiotic prophylaxis on infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy.

View Article and Find Full Text PDF

Purpose: For decades, an intrathoracic stomach (ITS) has been a definite indication for surgery due to the perceived risk of an acute volvulus with perforation, gangrene, or hemorrhage. At the present time, elective laparoscopic repair is the first choice for treatment of ITS. There is a lack of evidence in the long-term quality of life after a hiatal hernia repair for an intrathoracic stomach.

View Article and Find Full Text PDF

Purpose: Umbilical pilonidal sinus (UPS) has an atypical clinical presentation and is therefore not well recognized. The aim of this case series and review of the literature, is to provide more insight in the underlying pathology and a guidance for the treatment of this condition.

Methods: Three recent clinical cases are described that made us perform a multi-database research was to reveal relevant literature.

View Article and Find Full Text PDF

A mesenteric cyst is a rare cause for abdominal pain. This umbrella term includes cystic entities which reside in the mesentery. We present a case of an infected false mesenteric cyst in a 24-year-old female patient without prior surgery or known trauma.

View Article and Find Full Text PDF