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.

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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.

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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).

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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).

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Article Synopsis
  • The paper explores barriers to using AI in Health Technology Assessment (HTA) systems in Central and Eastern Europe, utilizing a literature review and focus group discussions for insights.
  • Most studies reviewed focus on clinical applications of AI, with a smaller number analyzing regulatory aspects and knowledge transfer, highlighting that many articles describe AI methods rather than their barriers.
  • Barriers found are categorized into data, methodology, technology, regulation, policy, and human factors, with a call for expert opinions to develop recommendations for overcoming these challenges and effectively integrating AI tools into HTA processes.
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Article Synopsis
  • The study identified key barriers to using real-world evidence (RWE) for health technology assessment in Central and Eastern Europe.
  • A mixed methods approach was used, including a literature review and discussions with stakeholders, to categorize barriers into five groups: technical, regulatory, clinical, scientific, and perceptional.
  • The authors recommend further research to develop detailed guidelines that enhance the consistency and standardization of RWE in health technology evaluations.
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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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Article Synopsis
  • Nissen fundoplication is the standard surgical treatment for gastroesophageal reflux disease (GERD), showing excellent short-term outcomes but lacking long-term quality of life data.
  • A study analyzed 175 patients who underwent this surgery over a 12-year period, finding a median post-operative quality of life score of 70 out of 75 and a re-operation rate of 13.6%.
  • Long-term results of the surgery were consistent with short-term success, indicating that patients generally experience good symptomatic relief even after several years.
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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.

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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.

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Article Synopsis
  • An intrathoracic stomach (ITS) has traditionally required surgery due to risks like volvulus and perforation, with laparoscopic repair now being the preferred elective treatment method.
  • A study analyzed outcomes for 86 patients who underwent hiatal hernia repair for ITS, focusing on patient characteristics, complications, and long-term quality of life through questionnaires.
  • Results showed high patient satisfaction and a low rate of symptom recurrence, with an average quality of life score of 13.5 and a median follow-up of 2.7 years, indicating successful outcomes from the laparoscopic procedure.
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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.

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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.

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