Population, Intervention, Comparison, Outcome Research Articles

The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction.

The first Asia–Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma were published in 2013. Since then, new evidence on the role of endoscopy for management of malignant hilar biliary obstruction (MHBO) has emerged. To update the recommendation, we reviewed the literature using a PICO (population/intervention/comparison/outcomes) framework and created consensus statements. The expert panel voted anonymously using the modified Delphi method, and all final statements were evaluated for the quality of evidence and strength of recommendation. The important points with inadequate supporting evidence were classified as key concepts. There were 7 statements and 5 key concepts that reached consensus. The statements and key concepts dealt with multiple aspects of endoscopy-based management in MHBO starting from diagnosis, strategies and options for biliary drainage, management of recurrent biliary obstruction, management of cholecystitis after biliary stenting, and adjunctive treatment before stenting. Although the recommendations may assist physicians in planning the treatment for MHBO patients, they should not replace the decision of a multidisciplinary team in the management of individual patients.

Hyperbaric Oxygen Therapy for Complications in Nipple-Sparing Mastectomy with Breast Reconstruction: A Systematic Review.

Background: Research advancing effective treatments for breast cancer is crucial for eradicating the disease, reducing recurrence, and improving survival rates. Nipple-sparing mastectomy (NSM), a common method for treating breast cancer, often leads to complications requiring re-operation. Despite advancements, the use of hyperbaric oxygen therapy (HBOT) for treating these complications remains underexplored. Therefore, we analyze the efficacy of HBOT in the post-operative care of patients undergoing NSM. Methods: A systematic search was conducted using PubMed, Scopus, and the Cochrane Library. Studies were assessed for eligibility using the PICO (Population, Intervention, Comparison, Outcome) framework and classified based on American Society of Plastic Surgeons (ASPS) levels of evidence. Seven studies, totaling a pool of 63 female patients, met the inclusion criteria. Among these studies, four were categorized as Level III (57.1%), one as Level IV (14.3%), and two as Level V (28.6%). These studies focused on HBOT's role in wound healing, the successful salvage of breast reconstruction, and the optimal timing for HBOT. Results: This review revealed that HBOT indeed has potential for improving tissue oxygenation, vascularization, and, consequently, wound healing. It is noted that HBOT is efficacious for mitigating post-NMS complications, including infections, re-operation, flap loss, seroma, and hematoma. Conclusions: Overall, HBOT could be beneficial in standard post-surgical care protocols for patients undergoing NSM due to its role in mitigating common adverse effects that occur after mastectomy. Despite promising outcomes, the recent literature lacks rigorous clinical trials and well-defined control groups, underscoring the need for further research to establish standardized HBOT protocols.

ACVIM consensus statement on the treatment of immune thrombocytopenia in dogs and cats.

Management of immune thrombocytopenia (ITP) in dogs and cats is evolving, but there are no evidence-based guidelines to assist clinicians with treatment decisions. Likewise, the overall goals for treatment of ITP have not been established. Immunosuppressive doses of glucocorticoids are the first line treatment, but optimal treatment regimens beyond glucocorticoids remain uncertain. Additional options include secondary immunosuppressive drugs such as azathioprine, modified cyclosporine, and mycophenolate mofetil, usually selected based on clinician preference. Vincristine, human IV immunoglobulin (hIVIg), and transfusion of platelet or red blood cell-containing products are often used in more severe cases. Splenectomy and thrombopoietin receptor agonists are usually reserved for refractory cases, but when and in which patient these modalities should be employed is under debate. To develop evidence-based guidelines for individualized treatment of ITP patients, we asked 20 Population Intervention Comparison Outcome (PICO) format questions. These were addressed by 17 evidence evaluators using a literature pool of 288 articles identified by a structured search strategy. Evidence evaluators, using panel-designed templates and data extraction tools, summarized evidence and created guideline recommendations. These were integrated by treatment domain chairs and then refined by iterative Delphi survey review to reach consensus on the final guidelines. In addition, 19 non-PICO questions covering scenarios in which evidence was lacking or of low quality were answered by expert opinion using iterative Delphi surveys with panelist integration and refinement. Commentary was solicited from multiple relevant professional organizations before finalizing the consensus. The rigorous consensus process identified few comparative treatment studies, highlighting many areas of ITP treatment requiring additional studies. This statement is a companion manuscript to the ACVIM Consensus Statement on the Diagnosis of Immune Thrombocytopenia in Dogs and Cats.

European Stroke Organisation (ESO) and European Society for Minimally Invasive Neurological Therapy (ESMINT) Guideline on Acute Management of Basilar Artery Occlusion.

The aim of the present European Stroke Organisation (ESO) guideline is to provide evidence-based recommendations on the acute management of patients with basilar artery occlusion (BAO). These guidelines were prepared following the Standard Operational Procedure of the ESO and according to the GRADE methodology.Although BAO accounts for only 1-2% of all strokes, it has very poor natural outcome. We identified 10 relevant clinical situations and formulated the corresponding Population Intervention Comparator Outcomes (PICO) questions, based on which a systematic literature search and review was performed. The working group consisted of 10 voting members (five representing ESO and five ESMINT) and three non-voting junior members. The certainty of evidence was generally very low. In many PICOs, available data were scarce or lacking, hence, we provided expert consensus statements.First, we compared intravenous thrombolysis (IVT) to no IVT, but specific BAO-related data do not exist. Yet, historically, IVT was standard of care for BAO patients who were also included (albeit in small numbers) in IVT trials. Non-randomised studies of IVT-only cohorts showed high proportion of favourable outcomes. Expert Consensus suggests using IVT up to 24 hours unless otherwise contraindicated. We further suggest IVT plus endovascular treatment (EVT) over direct EVT. EVT on top of best medical treatment (BMT) was compared to BMT alone within 6 and 6-24 hours from last seen well. In both time windows, we observed a different effect of treatment depending on a) the region where the patients were treated (Europe vs. Asia), b) on the proportion of IVT in the BMT arm, and c) on the initial stroke severity. In case of high proportion of IVT in the BMT group and in patients with NIHSS below 10, EVT plus BMT was not found better than BMT alone. Based on very low certainty of evidence, we suggest EVT+BMT over BMT alone (this is based on results of patients with at least 10 NIHSS points and a low proportion of IVT in BMT). For patients with an NIHSS below 10, we found no evidence to recommend EVT over BMT. In fact, BMT was non-significantly better and safer than EVT. Furthermore, we found a stronger treatment effect of EVT+BMT over BMT alone in proximal and middle locations of BAO compared to distal location. While recommendations for patients without extensive early ischaemic changes in the posterior fossa can, in general, follow those of other PICOs, we formulated an Expert Consensus Statement suggesting against reperfusion therapy in those with extensive bilateral and/or brainstem ischaemic changes. Another Expert Consensus suggests reperfusion therapy regardless of collateral scores. Based on limited evidence, we suggest direct aspiration over stent retriever as the first-line strategy of mechanical thrombectomy. As an Expert Consensus, we suggest rescue percutaneous transluminal angioplasty and/or stenting after a failed EVT procedure. Finally, based on very low certainty of evidence, we suggest add-on antithrombotic treatment during EVT or within 24 hours after EVT in patients with no concomitant IVT and in whom EVT was complicated (defined as failed or imminent re-occlusion, or need for additional stenting or angioplasty).

Clinical outcomes of milled, 3D-printed, and conventional complete dentures in edentulous patients: A systematic review and meta-analysis.

This systematic review aims to compare clinical outcomes of digital dentures with conventional dentures. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered in Prospero. The formulated population, intervention, comparison, outcome (PICO) question was "What is the clinical outcome of digital versus conventional complete dentures (CDs) in edentulous patients?". The search strategy used three main electronic databases and an additional manual search was completed in August 2023 by following an established search strategy. Initial inclusion was based on titles and abstracts, followed by a detailed review of selected studies, and clinical studies that evaluated the clinical outcome of digital (milled or 3D-printed) versus conventional CDs were included. A qualitative analysis for clinical studies was used to assess the risk of bias. The certainty of the evidence was assessed according to the grading of recommendations, assessment, development, and evaluations (GRADE) system. In addition, a single-arm meta-analysis was performed to evaluate the retention between digital versus conventional CDs. The initial search yielded a total of 947 articles, out of which 19 were selected for a comprehensive review, and six met the eligibility criteria to be included in this systematic review. The computer-aided design and computer-aided manufacturing (CAD-CAM) CDs showed increased retention, no relevant differences in oral health-related quality of life (OHRQoL), and shorter working time compared to conventional dentures. Two studies were eligible for meta-analysis; retention was significantly better among CAD-CAM fabricated dentures (standardized mean difference [SMD] 0.501) than conventional dentures. The heterogeneity between studies was high (95% CI: 0.049-0.952). Clinically, both the milled and the 3D-printed CD fared better than conventional dentures in terms of retention, reduction in the number of appointments, improved patient comfort, and improved predictable maintenance of the denture. Patients' perceptions and satisfaction were independent of the digital and conventional fabricated dentures.

Antibacterial Agents Used in Modifications of Dental Resin Composites: A Systematic Review

Introduction: Resin-based composites (RBCs) are very common and often applicable in dentistry. Their disadvantage is susceptibility to secondary caries due to the formation of bacterial biofilm at the interface with the patient’s tissues. Antimicrobial additive incorporation into RBCs seems to be a justified method to alleviate the above-mentioned negative phenomenon. The aim of this review is to provide a juxtaposition of strategies and results on the topic of antimicrobial composites. It also provides insights into future research and prospects for clinical applications. Methods: This review summarizes the literature from 2017 to 2024, describing potential antimicrobial agents incorporated into dental composites. The research methodology involved a systematic search using the Population/Intervention/Comparison/Outcome (PICO) structure and selecting articles from databases such as Pubmed, ScienceDirect, and Elsevier, which allowed for an in-depth review of substances utilized for the antibacterial modification of RBCs. Results: A total of 159 articles were identified, 43 of which met the inclusion criteria. Conclusions: This review is a summary of novel approaches in the field of dental materials science. The results show the variety of approaches to modifying composites for antimicrobial efficacy. It is worth underlining that there is a significant difficulty in comparing the studies selected for this review. This is related to the different modifiers used and the modification of composites with different compositions. Unfortunately, there is still a lack of a standardized approach to the modification of dental materials to give them a biocidal character and simultaneously maintain the stability of their mechanical and chemical properties.

Impact of preoperative balance training on postoperative functional recovery of patients after total knee arthroplasty: a systematic review and meta-analysis.

Previous studies' results on the impact of preoperative balance training on postoperative functional recovery after total knee arthroplasty (TKA) appeared to be ambiguous. Thus, this systematic review and meta-analysis were performed to investigate the effects of preoperative balance training on walking ability, balance-specific performance, and other functional indicators in elderly patients post-TKA. Patient data were obtained from databases including PubMed, Physiotherapy Evidence Database (PEDro), CINAHL, SPORTDiscus, and Scopus. The inclusion criteria followed the Population-Intervention-Comparison-Outcome (PICO) principle. The assessment process involved meticulous screening, judicious data extraction, and rigorous evaluation of trial method quality, conducted by two independent researchers. Based on standardized mean differences and 95% confidence intervals, meta-analysis was performed employing a random-effects model or fixed-effects model. Preoperative balance training appears to be a potentially effective intervention for enhancing the knee osteoarthritis (KOA) patients' knee joint function (RR = 1.16, 95% CI: -2.58, 4.91), isometric knee flexion (RR = 2.49, 95% CI: -2.53, 7.50), knee extension (RR = -0.13, 95% CI: -0.45, 0.18), knee society score (KSS) (RR = 2.18, 95% CI: -1.51, 5.88), stair test (RR = -0.73, 95% CI: -1.84, 0.37), and timed up and go (RR = -1.18, 95% CI: -1.60, -0.76). Compared to interventions with less emphasis on balance training, rehabilitation programs highly emphasizing balance training significantly enhance the walking ability, balance specificity, and functional indicators of elderly patients post-TKA. This includes rehabilitation programs for senior TKA patients, with a focus on activities meant to improve the sensory system, balance in particular.

Nutritional Interventions for the Prevention of Cognitive Decline in Patients With Mild Cognitive Impairment and Alzheimer Disease: Protocol for a Network Meta-Analysis of Randomized Controlled Trials.

Mild cognitive impairment (MCI) is the stage between cognitive decline due to physiological aging and the severity of decline seen in neurodegenerative disorders like Alzheimer disease (AD), which is among the most prevalent neurodegenerative disorders characterized by cognitive impairment. People with MCI are at increased risk of developing AD. Although MCI and AD are incurable, nutritional interventions can potentially delay or prevent their onset. Consequently, effective interventions used to decelerate or alleviate the progress of cognitive impairment in older people are a significant focus in geriatric care. Given the synergistic effects of nutrition on health, assessing the effectiveness of nutritional supplements or dietary composition in preventing MCI or AD is essential for developing interventional strategies. Our study aims to assess the effectiveness of various nutritional interventions, including special dietary types, dietary patterns, specific foods, nutritional intake, and nutritional supplements, in preventing cognitive decline among patients diagnosed with MCI or AD. To achieve this, we will use a comprehensive approach, including network meta-analysis, pairwise meta-analysis, and systematic review of randomized controlled trials (RCTs). The review will follow the Population, Intervention, Comparison, Outcome (PICO) model and the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines. Two investigators will independently search PubMed electronically. Data extraction will follow the inclusion criteria, and data will be assessed for risk of bias using a revised tool. Additionally, evidence quality will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. The outcomes of interest are assessing the cognitive outcomes in patients with MCI or AD. A systematic literature search will be conducted, identifying randomized controlled trials that investigate the impact of these nutritional interventions on cognitive function decline in individuals with MCI and AD. Network meta-analyses (random-effects model) and pairwise meta-analyses will then estimate the relative effectiveness of different nutritional interventions. We included 51 studies, published between 1999 and 2023 (27 studies for AD and 24 studies for MCI) and involving 8420 participants. We completed data extraction for all 51 studies by December 2023. Currently, we are actively engaged in data analysis and manuscript preparation. We plan to finalize the manuscript and publish the comprehensive results by the end of 2024. Our study holds significant clinical relevance given the rising prevalence of AD and the potential influence of nutritional interventions on cognitive function in individuals with MCI and AD. By investigating this relationship, our research aims to inform evidence-based decision-making in the development of prevention strategies for MCI and AD. The outcomes are expected to contribute to the establishment of reliable recommendations for MCI or AD management, providing substantial support in the field. PROSPERO CRD42022331173; http://tinyurl.com/3snjp7a4. PRR1-10.2196/47196.

Improving Well-Being and Fostering Health-Oriented Leadership among Leaders in Small and Medium-Sized Enterprises (SMEs): A Systematic Review.

Leaders of small and medium-sized enterprises (SMEs) are often confronted with specific burdens, which frequently result in increased levels of stress. Leadership behaviour, in turn, has a significant impact on employees' health and performance. Using the Population, Intervention, Comparison, Outcome (PICO) method, we conducted a systematic literature search covering publications from 2002 to 2023 using PubMed, PsycInfo and Business Source Premier on stress-reducing and well-being-improving interventions for SME leaders. The Effective Public Health Practice Project (EPHPP) Quality Assessment Tool was used to assess the methodological quality and risk of bias of the included studies regarding selection bias, study design, confounders, blinding, data collection, withdrawal and drop-out. Of the 3150 identified publications, 6 were included after screening. The studies varied in content (cognitive behavioural therapy [CBT]-based, psychoeducation, and mixed interventions) and approach (individual- and organisation-centred). Not all of the examined interventions provided significant outcomes. However, CBT-based and individualised approaches showed a positive trend in reducing SME leaders' psychosocial stress and improving their well-being. Despite the limited data, it can be concluded that such interventions are beneficial for leaders and their specific needs. Future research should focus on tailored approaches, derived from well-founded theories and integrative interventions addressing SME leaders.

Improving staff retention in the research and development department sections of NHS hospitals in the United Kingdom: A systematic review

Background: This study undertook a comprehensive examination of the imperative task of improving staff retention within the National Health Service (NHS) Research and Development (R&D) sector in the UK. The motivation stemmed from the observed decline in staff retention over the years, posing a significant threat to the continuity of healthcare research and innovation. Aim: The primary objective of this systematic review was to elucidate impactful measures aimed at enhancing staff retention within NHS R&D. The study recognized the critical role of sustained staff commitment in preventing disruptions to research projects, ensuring efficient resource utilization, and maintaining the retention of crucial knowledge, research quality, and impact. The overarching aim was to mitigate the potential hindrances to the progress of medical advancements. Method: Conducted as a systematic review, the study employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting checklist. The research followed the Population, Intervention, Comparison, Outcome (PICO) format to frame research questions systematically. A meticulous search and screening process was employed to identify relevant studies, and data synthesis methods were utilized to draw meaningful conclusions from the selected literature. Conclusion: The study concluded by emphasizing the critical need to address staff retention issues within NHS R&D sections. The systematic review supported a comprehensive and tailored approach, urging the NHS to invest in its researchers, create a supportive work environment, and prioritize the physical and mental well-being of staff. By implementing these evidenced-based strategies, the NHS can effectively enhance the retention of its research talent, thereby fostering ongoing healthcare innovation and improvement. The findings presented in this study contribute to a detailed understanding of staff retention issues within R&D sections, providing a valuable foundation for future initiatives in this crucial domain.

No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis.

No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis.

Sealing Ability of Root Canal Sealers in Warm Obturation Techniques Compared to Cold Obturation Techniques: A Systematic Review

Introduction: Obturation is a critical step in root canal treatment of the teeth that significantly contributes to its success. Various techniques are used for obturation of root canals. Aim: To compare the sealing efficiency of sealers under warm and cold obturation techniques across parameters such as Microleakage (ML), Push-out Bond Strength (PBS), and dentinal tubule penetration, which help evaluate the sealer-dentin interface in root canal systems. Materials and Methods: The research question was designed in the Population, Intervention, Comparison, Outcome (PICO) format, and the databases searched were Medical Literature Analysis and Retrieval System Online (MEDLINE), Cochrane, and Scopus following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Inclusion criteria included in-vitro studies between January 2011 and June 2021 in the English language, comparing the influence of both cold and warm obturation techniques on root canal sealers. Key parameters considered for evaluating the sealing ability of endodontic sealers were marginal adaptation, ML, and Dentinal Tubule Penetration (DTP). Two independent reviewers assessed studies for eligibility against the inclusion and exclusion criteria and conducted data extraction. Risk of bias assessment was performed using the Cochrane risk of bias assessment tool, Review Manager (v5.4). Results: A total of 19 articles were finalised for review, and methodological assessment for all parameters involved in the study was conducted using the Cochrane risk of bias assessment tool. Out of the total, five studies showed a moderate risk of bias, while the remaining 14 studies showed a low risk of bias. Conclusion: Warm and cold obturation techniques perform similarly in producing a good apical seal when used in root canal treatment with different endodontic sealer materials. Warm obturation techniques perform better than cold obturation techniques in producing homogeneous root canal fillings, while cold obturation techniques enhance push-out bond strength at the sealer-dentin interface.

An analysis of the recommendations of the 2022 Society for Vascular Surgery clinical practice guidelines for patients with asymptomatic carotid stenosis

ObjectivePatients with asymptomatic carotid artery stenosis currently account for the majority of carotid interventions performed in the United States; therefore, the following article will review the 2022 Society for Vascular Surgery (SVS) clinical practice guidelines perspective in treating patient with asymptomatic carotid stenosis. MethodsA systemic review and meta-analysis were conducted by the evidence practice center of the Mayo Clinic using a specified population, intervention, comparison, outcome (PICO) framework. ResultsBased on published randomized trials and related supporting evidence, the following were noted: the SVS recommends that patients with asymptomatic ≥70% stenosis can be considered for carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), or transfemoral carotid artery stenting (TFCAS) for the reduction of long-term risk of stroke, provided the patient has a life expectancy of 3 to 5 years with risk of perioperative stroke and death not exceeding 3%. The type of carotid intervention should be based on the presence or absence of high-risk criteria for each specified intervention. Data from CREST, ACT, and the Vascular Quality Initiative suggest that certain properly selected asymptomatic patients can be treated with carotid stenting with equivalent outcome to CEA in the hands of experienced interventionalists. The institutions and operator performing carotid stenting must exhibit expertise sufficient to meet the established American Heart Association guidelines for treatment of patient with asymptomatic carotid stenosis (ie, combined stroke/death rate of less than 3%). ConclusionsSVS recommends that low surgical risk patients with asymptomatic carotid stenosis of ≥70% to be treated with CEA with best medical therapy over medical therapy alone for the long-term prevention of stroke/death (GRADE 1B). Carotid intervention should also be based on the presence or absence of high-risk criteria for each specified intervention (ie, CEA, TCAR, and TFCAS).

Experiential learning in engineering education: A systematic literature review

AbstractBackgroundThe evolving transformations of our society at large, academic institutions, and engineering discipline in the 21st century have profound implications for the nature of experiential learning being offered in engineering education. However, what is experiential learning in the context of engineering education?PurposeThe introduction and evaluation of experiential learning in undergraduate engineering education between 1995 and 2020, as well as the essential elements for consideration in its future implementation, have been analyzed and synthesized.Design/MethodA population–intervention–comparison–outcome framework and PRISMA flow diagram were used to outline a systematic literature review on how experiential learning was introduced into undergraduate engineering curricula, how it was evaluated, and the essential elements for consideration in its future implementation.FindingsA total of 220 studies were synthesized. These studies offered a new lens of seeing experiential learning, which were interpreted as “paradigm shifts.” More than one‐half of the total studies were conducted between 1995 and 2005. These studies were strongly directed at measuring student performance and occurred in a decade when many North American engineering curricula were being restructured. The review indicated that experiential learning has been successfully carried out via diverse methodologies. However, there is a strong need to enrich it with a theoretical basis.ConclusionsExperiential learning introduced into engineering education appeared to be an interdependent self–school–community entity. In the changing work environment of the 21st century, heightened by the impacts of the COVID‐19 pandemic, invoking the inseparability of self, school, and community would provide unique perspectives to our evolving understanding of experiential learning and its relevance in engineering discipline.

American Burn Association Clinical Practice Guidelines on Burn Shock Resuscitation.

This Clinical Practice Guideline (CPG) addresses the topic of acute fluid resuscitation during the first 48 hours following a burn injury for adults with burns ≥20% of the total body surface area (%TBSA). The listed authors formed an investigation panel and developed clinically relevant PICO (Population, Intervention, Comparator, Outcome) questions. A systematic literature search returned 5978 titles related to this topic and after 3 levels of screening, 24 studies met criteria to address the PICO questions and were critically reviewed. We recommend that clinicians consider the use of human albumin solution, especially in patients with larger burns, to lower resuscitation volumes and improve urine output. We recommend initiating resuscitation based on providing 2 mL/kg/% TBSA burn in order to reduce resuscitation fluid volumes. We recommend selective monitoring of intra-abdominal and intraocular pressure during burn shock resuscitation. We make a weak recommendation for clinicians to consider the use of computer decision support software to guide fluid titration and lower resuscitation fluid volumes. We do not recommend the use of transpulmonary thermodilution-derived variables to guide burn shock resuscitation. We are unable to make any recommendations on the use of high-dose vitamin C (ascorbic acid), fresh frozen plasma (FFP), early continuous renal replacement therapy, or vasopressors as adjuncts during acute burn shock resuscitation. Mortality is an important outcome in burn shock resuscitation, but it was not formally included as a PICO outcome because the available scientific literature is missing studies of sufficient population size and quality to allow us to confidently make recommendations related to the outcome of survival at this time.

PP01 Health Technology Assessment Of Cervical Artificial Disc Replacement: Highlighting The Need For A Consistent International Approach

IntroductionCervical artificial disc replacement (C-ADR) is not a new technology but one that has seen many technological advances in the past 10 years. Indeed, a recent review described total disc arthroplasty as the most innovative development in the history of spinal surgery. The primary goals of C-ADR are to reduce or eliminate pain, and restore normal segmental motion. The aim of this analysis was to identify, extract and examine key health outcomes and economic data from published health technology assessment (HTA) reports on C-ADR, with the aim of understanding how the evolution of this technology has influenced assessments internationally.MethodsA comprehensive search of over 90 HTA organization websites and the INAHTA HTA database using key terms for C-ADR surgical procedures was coupled with a literature search of recent systematic reviews. No language restrictions were applied.ResultsTwenty HTA reports of C-ADR surgery published from 2005 to 2022 were included for review. Several HTAs (4/20) were updates or reassessments by the same agency and one was an update across agencies (Italy update of Belgian HTA). While many of the HTAs concluded C-ADR is as effective as standard care and superior in certain outcomes, there was no pattern or consistency in the conclusions or recommendations from these assessments, even as the evidence base expanded over time. Our analysis found this was largely due to variations in HTA approaches among agencies including: differences in research questions asked, PICO (Population, Intervention, Comparator, Outcomes) criteria and methods performed, such as: rapid versus full systematic reviews; inclusion of economic evaluations and/or budget impact analyses.Indeed, one of the only predictive factors for a positive HTA was a favorable cost-effectiveness analysis.ConclusionsC-ADR is an established technology with extensive HTA investigation internationally. The lack of a consistent approach taken by HTA bodies made prediction of successful HTA outcomes difficult. Future alignment of key evaluation processes and methods may help address current international variations and support consistent decision making on patient access.

HTA111 Population, Intervention, Comparator, Outcomes (PICO) of ATMPs and Potential Impact on the Upcoming EU Regulation on HTA

HTA111 Population, Intervention, Comparator, Outcomes (PICO) of ATMPs and Potential Impact on the Upcoming EU Regulation on HTA

Airway management in neonates and infants: European Society of Anaesthesiology and Intensive Care and British Journal of Anaesthesia joint guidelines

Airway management is required during general anaesthesia and is essential for life-threatening conditions such as cardiopulmonary resuscitation. Evidence from recent trials indicates a high incidence of critical events during airway management, especially in neonates or infants. It is important to define the optimal techniques and strategies for airway management in these groups. In this joint European Society of Anaesthesiology and Intensive Care (ESAIC) and British Journal of Anaesthesia (BJA) guideline on airway management in neonates and infants, we present aggregated and evidence-based recommendations to assist clinicians in providing safe and effective medical care. We identified seven main areas of interest for airway management: i) preoperative assessment and preparation; ii) medications; iii) techniques and algorithms; iv) identification and treatment of difficult airways; v) confirmation of tracheal intubation; vi) tracheal extubation, and vii) human factors. Based on these areas, Population, Intervention, Comparison, Outcomes (PICO) questions were derived that guided a structured literature search. GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to formulate the recommendations based on those studies included with consideration of their methodological quality (strong '1' or weak '2' recommendation with high 'A', medium 'B' or low 'C' quality of evidence). In summary, we recommend: 1. Use medical history and physical examination to predict difficult airway management (1C). 2. Ensure adequate level of sedation or general anaesthesia during airway management (1B). 3. Administer neuromuscular blocker before tracheal intubation when spontaneous breathing is not necessary (1C). 4. Use a videolaryngoscope with an age-adapted standard blade as first choice for tracheal intubation (1B). 5. Apply apnoeic oxygenation during tracheal intubation in neonates (1B). 6. Consider a supraglottic airway for rescue oxygenation and ventilation when tracheal intubation fails (1B). 7. Limit the number of tracheal intubation attempts (1C). 8. Use a stylet to reinforce and preshape tracheal tubes when hyperangulated videolaryngoscope blades are used and when the larynx is anatomically anterior (1C). 9. Verify intubation is successful with clinical assessment and end-tidal CO2 waveform (1C). 10. Apply high-flow nasal oxygenation, continuous positive airway pressure or nasal intermittent positive pressure ventilation for postextubation respiratory support, when appropriate (1B).

Consensus-Based Best Practice Recommendations for Myelofibrosis Management in Routine Clinical Practice with a Focus on Patients with Cytopenias: Systematic Literature Review and Clinical Practice Recommendations from a Global Consensus Group

Background: Myelofibrosis (MF) is a BCR-ABL1-negative myeloproliferative neoplasm (MPN) characterized by progressive bone marrow fibrosis, splenomegaly, and cytopenias due to impaired hematopoiesis (Passamonti and Mora. Blood 2022). Despite the availability of comprehensive national and international guidelines for diagnosing and managing MF, gaps remain in translating these guidelines into clinical practice, particularly for patients with cytopenias, non-response or intolerance to Janus kinase (JAK) inhibitor treatment, and those ineligible for clinical trial enrollment. Consequently, an international expert consensus group was established with the objective of augmenting the existing guidance. Objectives: To develop a set of evidence- and consensus-based recommendations for managing MF in routine clinical practice, with a focus on patients with cytopenias, including practical strategies and tools to support clinicians. Methods : Modified Delphi methodology was utilized to achieve consensus (Figure 1). A Steering Committee (SC) of 9 expert hematologists (the authors) was established. During an initial meeting, the SC proposed 25 clinical questions that addressed key issues across 5 consensus themes: 1) Defining the thresholds for anemia and when to initiate/modify treatment; 2) defining the threshold for thrombocytopenia and when to initiate/modify treatment; 3) defining JAK inhibitor failure and what would warrant switching treatment; 4) how and when to determine prognosis in patients with MF; and, 5) unmet needs in MF clinical trials. An extended faculty (EF) was then enlisted, comprising hematologists and patient advocacy groups, who voted on the importance of the questions to address. The 15 highest scoring questions were selected for the consensus program (Table 1). To gather scientific evidence around the questions, a systematic literature review (SLR) was conducted using the PubMed and Embase databases, adhering to a PICO (Population, Intervention, Comparison, Outcome) framework. In a subsequent meeting, recommendations were formulated to address the questions using evidence from the SLR and the expert clinical experience of the SC. An online voting platform was then used for both the SC and EF to provide an agreement score for each recommendation. Consensus was achieved when 75% of the respondents agreed within the range of 7-9 on a 9-point scale (1=strongly disagree, 9=strongly agree). Results: Consensus was achieved among voters (hematologists [n=29] and patients [n=9] from Europe, the United States, Canada, Australia, and Israel) for all 15 recommendations. Recommendations in theme 1 emphasize the importance of comprehensive evaluation, exclusion of other causes of anemia, therapy dose optimization, and consideration of additional treatments for managing anemia in patients with MF. Recommendations in theme 2 highlight the complexity of managing splenomegaly, symptoms, and anemia in patients with low platelet counts, and factors guiding therapy selection for these patients. Theme 3 recommendations discuss criteria used to determine JAK inhibitor failure, including relapse, refractoriness, or intolerance, and guidance for distinguishing between these. In theme 4, recommendations address the use of validated prognostic scores at diagnosis and during the disease course, and transplantation risk assessment. The limitations and appropriate utilization of these scores are emphasized, and the need to develop prognostic scores in pre-primary MF is highlighted. Theme 5 recommendations cover the importance of addressing unmet needs in MF clinical trials, and include striving for inclusivity by removing barriers to the participation of underserved patient populations and focusing efforts on validating additional endpoints beyond traditional measures. Conclusions: An international panel of physicians with expertise in MF, together with a diverse EF, was able to achieve a high level of consensus across a wide range of critical gaps in MF management. These recommendations provide a valuable framework to support clinicians in optimizing care for patients with MF.

Evidence-Based Guideline for Prehospital Airway Management

Airway management is a cornerstone of emergency medical care. This project aimed to create evidence-based guidelines based on the systematic review recently conducted by the Agency for Healthcare Research and Quality (AHRQ). A technical expert panel was assembled to review the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. The panel made specific recommendations on the different PICO (population, intervention, comparison, outcome) questions reviewed in the AHRQ review and created good practice statements that summarize and operationalize these recommendations. The recommendations address the use of ventilation with bag-valve mask ventilation alone vs. supraglottic airways vs. endotracheal intubation for adults and children with cardiac arrest, medical emergencies, and trauma. Additional recommendations address the use of video laryngoscopy and drug-assisted airway management. These recommendations, and the associated good practice statements, offer EMS agencies and clinicians an opportunity to review the available evidence and incorporate it into their airway management strategies.