Necrotizing enterocolitis (NEC) is a severe intestinal condition primarily affecting preterm neonates. It has a high mortality rate, particularly in infants with a birthweight of below 1,500 g or for those requiring surgical intervention. The European Reference Network for Inherited and Congenital Anomalies (ERNICA) has developed a clinical practice guideline to aid clinical decision-making pertaining to the surgical treatment and management of NEC in preterm neonates. This guideline was developed in accordance with the Guidelines 2.0 checklist and GRADE methodology. A multidisciplinary group of Europe's top experts collaborated with patient representatives to develop this guideline. After selecting critical points in care for which recommendations are required, a systematic review of the literature and critical appraisal of the evidence was performed. The Evidence to Decision framework was used as a guide to structure the consensus meetings and draft the recommendations. The panel developed seven recommendations and three good practice statements on the following topics: indications for surgery, peritoneal drainage, surgical technique, management of extensive NEC, enteral feeding, and neurodevelopmental outcomes in premature neonates with NEC. The certainty of evidence was graded as (very) low for most recommendations. However, the panel weighed up the benefits and harms in light of all relevant arguments and expert opinion. This guideline provides recommendations on caring for premature neonates with NEC. These recommendations can assist clinicians in their care decisions and can inform families on treatment options and relevant considerations. This guideline will be revised every 5 years to ensure it remains up to date.
- MeSH
- Enteral Nutrition MeSH
- Clinical Decision-Making MeSH
- Humans MeSH
- Evidence-Based Medicine MeSH
- Enterocolitis, Necrotizing * surgery diagnosis MeSH
- Infant, Premature MeSH
- Infant, Newborn MeSH
- Check Tag
- Humans MeSH
- Infant, Newborn MeSH
- Publication type
- Journal Article MeSH
- Practice Guideline MeSH
- Systematic Review MeSH
- Geographicals
- Europe MeSH
Cohort studies are a robust analytical observational study design that explore the difference in outcomes between two cohorts, differentiated by their exposure status. Despite being observational in nature, they are often included in systematic reviews of effectiveness, particularly when randomized controlled trials are limited or not feasible. Like all studies included in a systematic review, cohort studies must undergo a critical appraisal process to assess the extent to which a study has considered potential bias in its design, conduct, or analysis. Critical appraisal tools facilitate this evaluation. This paper introduces the revised critical appraisal tool for cohort studies, completed by the JBI Effectiveness Methodology Group, who are currently revising the suite of JBI critical appraisal tools for quantitative study designs. The revised tool responds to updates in methodological guidance from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group and reporting guidance from PRISMA 2020, providing a robust framework for evaluating risk of bias in a cohort study. Transparent and rigorous assessment using this tool will assist reviewers in understanding the validity and relevance of the results and conclusions drawn from a systematic review that includes cohort studies. This may contribute to better evidence-based decision-making in health care. This paper discusses the key changes made to the tool, outlines justifications for these changes, and provides practical guidance on how this tool should be interpreted and applied by systematic reviewers.
- MeSH
- Cohort Studies MeSH
- Humans MeSH
- Research Design * standards MeSH
- Bias * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
PURPOSE: Part II of this consensus aimed to provide recommendations for the prevention of meniscus injuries, nonoperative treatment of acute tears and degenerative lesions, return to sports and patient-reported outcome measures. METHODS: This consensus followed the European Society of Knee Surgery, Sports Traumatology and Arthroscopy (ESSKA) formal consensus methodology. For this combined ESSKA-American Orthopedic Society for Sports Medicine (AOSSM)-American Academy of Sports Physical Therapy (AASPT) initiative, 67 experts from 14 countries, including orthopedic surgeons and physiotherapists, were involved. The 26 Steering Group members established guiding questions, screened the existing evidence, and proposed statements, and provided Grades of recommendations. The 41 Rating Group members assessed the statements according to a Likert scale (1-9). Final documents were assessed by an international peer review group for geographical adaptability. RESULTS: Low to moderate scientific level of evidence was available, so that grades of recommendations were low (3 Grade A ratings, 4 Grade B, 3 Grade C and 13 Grade D), underlining the relevance of this consensus. One strong and 17 relative agreements with overall median of 8 (8-9) and a mean of 7.92 ± 0.37 were achieved for 23 statements on 18 questions. Prevention of meniscus injuries is possible with general knee injury reduction programs and through avoidance of certain activities. Non-operative treatment including physical therapy is the first line approach for degenerative meniscus lesions and may be an option for some acute tears. Return to sports after meniscus tear surgery should be both criterion-based and timebased. Patient reported outcomes in combination with performance-based measures are recommended to evaluate the rehabilitation process. CONCLUSION: This international EU-US consensus established recommendations for prevention strategies, describes rehabilitation of nonoperated patients and of patients after partial meniscectomy, meniscus repair and meniscus reconstruction, and establishes return to sport criteria. These updated and structured recommendations may be applied by surgeons and physiotherapists. LEVEL OF EVIDENCE: Level I, consensus.
- Publication type
- Journal Article MeSH
INTRODUCTION: Pathogenesis of large B-cell lymphomas (LBCL) and follicular lymphomas (FL) is a multistep process associated with the development of diverse DNA alterations and consequent deregulation of critical cellular processes. Detection of tumor-associated mutations within non-tumor compartments (mainly plasma) is the basis of the 'liquid biopsy' concept. Apart from tumor mutational profiling, quantitative analysis of circulating tumor DNA (ctDNA) allows longitudinal assessment of tumor burden. ctDNA-based technologies provide a new tool for tumor diagnostics and treatment personalization. AREAS COVERED: Our review provides a comprehensive overview and summary of available ctDNA studies in LBCL and FL. The accuracy of ctDNA-based detection of lymphoma-associated DNA alterations is correlated to known LBCL and FL molecular landscape. Additionally, we summarized available evidence that supports and justifies the clinical use of ctDNA for lymphoma risk stratification, treatment response evaluation, and treatment response-adapted therapy. Lastly, we discuss other clinically important ctDNA applications: monitoring of lymphoma clonal evolution within resistance and/or relapse development and utilization of ctDNA for diagnostics in non-blood fluids and compartments (e.g. cerebrospinal fluid in primary CNS lymphomas). EXPERT OPINION: Despite certain challenges, including methodological standardization, ctDNA holds promise to soon become an integral part of lymphoma diagnostics and treatment management.
- MeSH
- Circulating Tumor DNA * blood genetics MeSH
- Lymphoma, Large B-Cell, Diffuse * diagnosis genetics therapy blood MeSH
- Lymphoma, Follicular * diagnosis genetics therapy blood MeSH
- Humans MeSH
- Mutation MeSH
- Biomarkers, Tumor * blood genetics MeSH
- Prognosis MeSH
- Liquid Biopsy methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
PURPOSE: The aim of part one of this EU-US consensus was to combine literature research and expertise to provide recommendations for the usage of rehabilitation (including physical therapy) of patients undergoing surgical treatment for degenerative meniscus lesions or acute meniscus tears (including meniscectomy, repair, or reconstruction). Prevention programmes, non-operative treatment of acute tears and degenerative lesions, return to sports and patient-reported outcome measures will be presented in a part II article. METHODS: This consensus followed the European Society for Sports Traumatology and Arthroscopy (ESSKA)'s "formal consensus" methodology. For this combined ESSKA, American Orthopedic Society for Sports Medicine and American Academy of Sports Physical Therapy initiative, 67 experts (26 in the steering group and 41 in the rating group) from 14 countries (US and 13 European countries), including orthopaedic surgeons, sports medicine doctors and physiotherapists were involved. Steering group members established guiding questions, searched the literature and proposed statements. Rating group members assessed the statements according to a Likert scale and provided grades of recommendations, reaching a final agreement about rehabilitation of the knee after meniscus surgery. Final documents were then assessed by a peer review group to address the geographical adaptability. RESULTS: The overall level of evidence in the literature was low. Of the 19 questions (leading to 29 statements), 1 received a Grade A of recommendation, 2 a Grade B, 9 a Grade C and 17 a Grade D. Nevertheless, the mean median rating of all questions was 8.2/9 (9 being the highest rating on a scale of 1-9). The global mean rating was 8.4 ± 0.2, indicating a high agreement. Rehabilitation depends on the type of lesion, the treatment performed and is the same after medial or lateral meniscus surgery. Rehabilitation after meniscectomy should follow a criterion-based rehabilitation protocol, based on milestones rather than a time-based protocol. After meniscus repair and reconstruction, rehabilitation should be progressed according to both time and criterion-based milestones. CONCLUSION: Rehabilitation after meniscus surgery is a debated topic that may influence surgical outcomes if not optimally performed. This international formal consensus established clear, updated and structured recommendations for both surgeons and physiotherapists treating patients after meniscus surgery. LEVEL OF EVIDENCE: Level I, consensus.
- Publication type
- Journal Article MeSH
INTRODUCTION: The objective of this systematic review is to evaluate the efficacy and safety of antigen-specific tolerance-inducing therapeutic approaches (products based on peptides, DNA and T cells) versus placebo or other comparators, where possible, in adult multiple sclerosis (MS) patients. METHODS: PubMed, CINAHL, Web of Science, Cochrane and International Clinical Trials Registry Platform, ClinicalTrials.gov were searched for published and unpublished studies. Screening, critical appraisal, and data extraction for included studies were carried out by two independent reviewers. For efficacy, phase I, II and III clinical trials (randomized/non-randomized; double blind/single blind/unblinded; single-center/multicenter; single-arm/two-arm) and for safety, phase I, II and III clinical trials (randomized/non-randomized; double blind/single blind/unblinded; controlled/uncontrolled; single-center/multicenter; single-arm/two-arm) were included. Observational studies (cross-sectional studies, cohort studies, case studies/reports etc), review articles, systematic reviews, meta-analysis, preclinical and pilot studies were excluded. All included studies were critically appraised using standardized JBI tools, with no exclusions based on methodological quality. Where possible, studies were pooled in statistical meta-analysis, presented in tabular format, and accompanied by narrative synthesis. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for grading the certainty of evidence. RESULTS: Search yielded 2644 results and in total 26 studies were included in the final analysis. Twelve studies were RCTs and 14 were quasi-experimental. In total, there were 1427 subjects from the RCTs, and 314 from non-RCTs. Sample size of studies ranged from 10 to 612 patients. All studies included adult patients, principally aged 18-55/65 years. Critical appraisal scores for the RCTs were in the range 31% to 92%. For quasi-experimental studies, critical appraisal scores were in the range 45% to 78%. Due to high heterogeneity of the studies, efficacy of all antigen-specific treatment remained ambiguous. For all three types of treatment, there was no statistical difference in occurrence of adverse effects (AEs) between the treatment- and placebo-related AEs (for DNA-based treatment RR was 1.06 (0.94-1.10), p = 0.334; for peptides-base treatments RR was 1.04 (0.90-1.08), p = 0.115; for T-cells-based treatments RR was 1.31 (0.97-1.76), p = 0.08). There were no differences in RR for serious AEs (SAEs) between the treatments either for DNA-based treatment (RR was 0.63 (0.25-1.58), p = 0.322) or peptide-based treatment (RR was 0.86 (0.62-1.19), p = 0.361). There were no reported SAEs for T cell-based treatments, so meta-analysis for these therapies was not performed. The most frequent AEs were local reactions to injection, such as redness, erythema, pain. DISCUSSION: Antigen-specific tolerance-inducing therapeutic approaches appeared to be safe. However, the certainty for these results was very low for SAEs in peptide- and DNA-based therapies, whereas it was low for AEs in DNA- and T cells-based therapies and moderate for AEs in peptide-based therapies. The efficacy of antigen-specific therapies remains ambiguous. Larger, well-designed studies with high level quality are needed to ensure ultimate conclusions. REGISTRATION: The registration number provided following registration of the protocol in PROSPERO is 'CRD42021236776'.
- MeSH
- Antigens * immunology therapeutic use MeSH
- Humans MeSH
- Multiple Sclerosis * therapy immunology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Systematic Review MeSH
Arrested or protracted labor in nulliparous women caused by insufficient uterine contractility is a common problem in obstetrics, for which few management guidelines exist. The European Association of Perinatal Medicine nominated an expert panel, consisting of specialists in obstetrics and gynecology and midwives representing their respective professional national societies in nine European countries and patient representatives. The panel developed an evidence-based guideline for clinical practice supported by the Knowledge Institute of the Dutch Association of Medical Specialists. Five priority clinical questions (PICOs) were identified on nulliparous women, at term, with a singleton fetus, in cephalic presentation, and the diagnosis of arrested or protracted labor. For each question relevant outcome measures were defined as well as a minimal clinically important difference for each of them. Five literature searches were performed by an information specialist and articles were selected independently by two panel members. The GRADE methodology was used to write evidence summaries, considerations, and recommendations. The draft guideline was sent out for review to scientific societies involved in perinatal care in 20 European countries. Comments were answered, and the guideline was revised accordingly. The following procedures should be offered to women: 1) Amniotomy alone may be considered. 2) Women should be informed that there is no scientific evidence regarding the beneficial effects of immediate (<1 h) or delayed administration of oxytocin, although the first option may reduce the duration of labor. A joint decision is recommended, based on clinical judgment, and women's values and preferences. 3) A low-dose oxytocin regimen for labor augmentation should be considered. 4) Amniotomy should be considered before the administration of oxytocin infusion during the first stage of spontaneous labor. 5) Oxytocin augmentation for at least four hours with adequate uterine contractions should be considered, before an operative delivery is proposed, provided that fetal and maternal conditions are adequate.
- MeSH
- Amniotomy MeSH
- Dystocia * therapy diagnosis MeSH
- Obstetric Labor Complications * therapy diagnosis MeSH
- Humans MeSH
- Oxytocin administration & dosage MeSH
- Parity MeSH
- Labor, Obstetric MeSH
- Pregnancy MeSH
- Oxytocics administration & dosage MeSH
- Delivery, Obstetric MeSH
- Check Tag
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Practice Guideline MeSH
- Geographicals
- Europe MeSH
BACKGROUND: This study aimed to investigate: (a) the effects of aerobic training (AT) on brachial artery endothelial function, measured by flow-mediated dilatation (baFMD) and whether changes in baFMD are associated with changes in other cardiovascular health markers in healthy adults; (b) whether intra-individual response differences (IIRD) in baFMD improvement exist following AT; and (c) the association between participants' baseline characteristics and exercise-induced changes in baFMD. METHODS: The search conducted across six databases (PubMed, Web of Science, CINAHL, EMBASE, the Cochrane Central Register of Controlled Trials, and EBSCOhost) identified 12 eligible studies. We conducted both traditional meta-analyses identifying the effects of the intervention and IIRD. IIRD meta-analysis was performed to assess if true IIRD between AT and the control group exists for baFMD. The methodological quality of included studies was assessed by the PEDro scale, while GRADE assessment was used for certainty of evidence evaluation. RESULTS: In total, 12 studies with 385 participants (51% male, 46.3 ± 17.3 [years]) were included in the current review. Meta-analysis revealed improvement in baFMD post-AT (small MD = 1.92%, 95% CI 0.90 to 2.94, p = 0.001). The standard deviation of change scores in the intervention and control groups suggests that most of the variation in the observed change from pre-to-post intervention is due to other factors (e.g., measurement error, biological variability etc.) unrelated to the intervention itself. However, subgroup meta-analysis revealed that significantly trivial IIRD exists following AT in prehypertensive individuals. CONCLUSIONS: The study found small improvements in baFMD, suggesting an average 19.2% reduction in cardiovascular disease (CVD) risk, with some individuals-such as prehypertensive individuals-potentially experiencing even greater benefits from AT. However, a meta-analysis based on IIRD suggests that factors unrelated to AT predominantly explain baFMD changes. Further research is needed to better understand response variability in individuals with cardiovascular risk factors, and longer studies are required to assess IIRD in the general population.
- Publication type
- Journal Article MeSH
OBJECTIVES: To assess the efficacy and safety of pharmacological interventions for preventing upper gastrointestinal (GI) bleeding in people admitted to intensive care units (ICUs). DESIGN AND SETTING: Systematic review and frequentist network meta-analysis using standard methodological procedures as recommended by Cochrane for screening of records, data extraction and analysis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence. PARTICIPANTS: Randomised controlled trials involving patients admitted to ICUs for longer than 24 hours were included. SEARCH METHODS: The Cochrane Gut Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Latin American and Caribbean Health Science Information database (LILACS) databases were searched from August 2017 to March 2022. The search in MEDLINE was updated in April 2023. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP). MAIN OUTCOME MEASURES: The primary outcome was the prevention of clinically important upper GI bleeding. RESULTS: We included 123 studies with 46 996 participants. Cimetidine (relative risk (RR) 0.56, 95% CI 0.40 to 0.77, moderate certainty), ranitidine (RR 0.54, 95% CI 0.38 to 0.76, moderate certainty), antacids (RR 0.48, 95% CI 0.33 to 0.68, moderate certainty), sucralfate (RR 0.54, 95% CI 0.39 to 0.75, moderate certainty) and a combination of ranitidine and antacids (RR 0.13, 95% CI 0.03 to 0.62, moderate certainty) are likely effective in preventing upper GI bleeding.The effect of any intervention on the prevention of nosocomial pneumonia, all-cause mortality in the ICU or the hospital, duration of the stay in the ICU, duration of intubation and (serious) adverse events remains unclear. CONCLUSIONS: Several interventions seem effective in preventing clinically important upper GI bleeding while there is limited evidence for other outcomes. Patient-relevant benefits and harms need to be assessed under consideration of the patients' underlying conditions.
Introduction: Sufficient continuous preparation is needed to ensure that citizens are able to respond adequately in the event of emergencies. This preparation is a continuous process of education in the Czech Republic that is part of primary school educational programmes.Objective: To determine the knowledge of 6th and 9th grade primary school students in the field of protection of people in emergencies.Methodology: A questionnaire survey was conducted among a group of 1,943 respondents at 19 primary schools in the Olomouc and Moravian-Silesian regions in 2018 to 2019.Results: The results showed that students in 6th, 7th and 8th grades have the same level of knowledge, and that the knowledge of students in the 9th grade is at a higher level. An average level of knowledge was found in 42.98% of students, 29.64% of students have below-average knowledge, and 27.38% of students have above-average knowledge.Conclusion: The results indicate that the sub-objectives set out in the Framework Education Programme for Basic Education have not been fully met. The authors propose teaching the topic of Protection of People in Emergencies from the 6th to 8th grade cross-sectionally in individual subjects, and adding it as a separate subject in the 9th grade.
- MeSH
- Security Measures organization & administration statistics & numerical data MeSH
- Civil Defense * statistics & numerical data education MeSH
- Clinical Studies as Topic methods MeSH
- Humans MeSH
- Disaster Planning organization & administration statistics & numerical data MeSH
- Surveys and Questionnaires MeSH
- Schools statistics & numerical data MeSH
- Students * statistics & numerical data MeSH
- Educational Measurement statistics & numerical data MeSH
- Health Knowledge, Attitudes, Practice MeSH
- Knowledge * MeSH
- Check Tag
- Humans MeSH
