Multidisciplinary Expert Panel Research Articles

Defining child maltreatment for research and surveillance: a Delphi study in 34 countries

Abstract Background Child maltreatment is a complex public health issue that has consequences across the life-course. Studies to measure child maltreatment and identify interventions and services are constrained by a lack of uniform definitions across sectors and countries. We conducted a Delphi study to reach consensus on types and characteristics of child maltreatment for use in surveillance and research in Europe. Methods Statements were developed following a scoping review and identification of key concepts by an international expert team (n = 19). A multidisciplinary expert panel (n = 70) from 34 countries participated in three rounds of online data collection. We defined consensus as ≥ 70% agreement or disagreement with each statement after the final round. Results Consensus was reached on 26/31 statements, with a participant retention rate of 94%. The definition states that child maltreatment is a subtype of violence against children. The perpetrator can be an adult or minor, but must be in a position of power over the child. To define an act or omission as child maltreatment, it must cause harm or have the potential to cause harm, regardless of intention, severity, chronicity, or the traditional/cultural beliefs of the perpetrator. In addition, the broad umbrella term encompassing emotional, behavioural or cognitive maltreatment should be “psychological”, and psychological maltreatment should be split into sub-types of psychological abuse and psychological neglect. “Neglect” is a broad type of child maltreatment within which there are subtypes that can all be characterised as “failure to provide” or “failure to supervise”. Conclusions This is the first study to demonstrate consensus on the types and key characteristics of child maltreatment across multiple sectors and countries, providing a unified definition of child maltreatment to improve consistency of measurement and surveillance in Europe. This abstract is submitted on behalf of Working Group 1 COST Action 19106. Key messages • A standardised definition is essential for monitoring child maltreatment. • We propose a consensus-based definition that can be used to improve child maltreatment measurement in research and surveillance.

A Saudi Heart Association Position Statement on Obesity and Cardiovascular Disease.

The obesity pandemic is a major public health concern in Saudi Arabia, with significant impact on cardiovascular disease (CVD). This position statement aims to provide an overview of available evidence as well as the recommendations of the Saudi Heart Association on the management of obesity associated with CVD. Under the auspices of the Saudi Heart Association, a multidisciplinary expert panel comprised of cardiologists and endocrinologists discussed available evidence and provided recommendations on the management of obesity in CVD. The expert panel discussions occurred between September of 2023 and May of 2024 and also took into consideration local expertise in addition to published data in the management of obesity and CVD in the Kingdom of Saudi Arabia. The expert panel explored studies on obesity and its implication on CVD assessment modalities, while also examining the efficacy and cardiovascular safety of available interventions for weight reduction. The association between obesity and CVD is undeniable. The treatment of obesity, be it through lifestyle changes, pharmacological therapy or surgery, is an effective strategy for both weight loss as well as the primary and secondary prevention of CVD. The Saudi Heart Association position statement thus provides guidance and recommendations for the management of obesity/overweight and CVD in Saudi Arabia. This position statement is expected to contribute towards obesity and CVD prevention efforts in Saudi Arabia by promoting adequate and time-appropriate treatment of these conditions.

Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America.

Biosimilars offer significant advantages for improving access to biologic treatments in Latin America. However, their uptake has been slow due to misconceptions, regulatory uncertainties, and inadequate pharmacovigilance. To address these issues, Americas Health Foundation convened a multidisciplinary panel of regional experts in biosimilar use and interchangeability from Latin America. The panel assessed the current landscape and recommended steps to enhance access. Key recommendations include strengthening biosimilar regulations, ensuring transparent enforcement, implementing robust pharmacovigilance, and promoting collaboration among stakeholders to educate about the safety, efficacy, and economic advantages of biosimilars and their interchangeability. By embracing biosimilars and interchangeability, Latin American countries can expand patient access, foster competition, diversify treatment sources, and enhance the sustainability of their healthcare systems. However, achieving these goals requires addressing knowledge gaps and biases among healthcare providers, patients, regulators, and government agencies. This can be accomplished through clear communication and the use of real-world evidence.

European Society of Intensive Care Medicine guidelines on end of life and palliative care in the intensive care unit.

The European Society of Intensive Care Medicine (ESICM) has developed evidence-based recommendations and expert opinions about end-of-life (EoL) and palliative care for critically ill adults to optimize patient-centered care, improving outcomes of relatives, and supporting intensive care unit (ICU) staff in delivering compassionate and effective EoL and palliative care. An international multi-disciplinary panel of clinical experts, a methodologist, and representatives of patients and families examined key domains, including variability across countries, decision-making, palliative-care integration, communication, family-centered care, and conflict management. Eight evidence-based recommendations (6 of low level of evidence and 2 of high level of evidence) and 19 expert opinions were presented. EoL legislation and the importance of respecting the autonomy and preferences of patients were given close attention. Differences in EoL care depending on country income and healthcare provision were considered. Structured EoL decision-making strategies are recommended to improve outcomes of patients and relatives, as well as staff satisfaction and mental health. Early integration of palliative care and the use of standardized tools for symptom assessment are suggested for patients at high risk of dying. Communication training for ICU staff and printed communication aids for families are advocated to improve outcomes and satisfaction. Methods for enhancing family-centeredness of care include structured family conferences and culturally sensitive interventions. Conflict-management protocols and strategies to prevent burnout among healthcare professionals are also considered. The work done to develop these guidelines highlights many areas requiring further research.

Germline and somatic testing for homologous repair deficiency in patients with prostate cancer (part 1 of 2).

Unfortunately, not all metastatic castration resistant prostate cancer (mCRPC) patients receive available life-prolonging systemic therapies, emphasizing the need to optimize mCRPC treatment selections. Better guidelines are necessary to determine genetic testing in prostate cancer. In this two-part expert opinion-based guide, we provide an expert consensus opinion on the utilization of germline and somatic testing to detect HRR alterations in patients with mCRPC. This guide was developed by a multidisciplinary expert panel that convened in 2023-2024, including representatives from medical oncology, urology, radiation oncology, pathology, medical genomics, and basic science. We argue for the widespread adoption of germline testing in all patients with prostate cancer and for somatic mutations testing in patients at the time of recurrent/metastatic disease. In this first part, we review how genomic testing is performed. We also review how to overcome certain barriers to integrate genetic and biomarker testing into clinical practice.

Development of an Emergency Department Safety Checklist through a global consensus process.

Emergency departments (EDs) are at high risk for medical errors. Checklist implementation programs have been associated with improved patient outcomes in other high-risk clinical settings and when used to address specific aspects of ED care. The aim of this study was to develop an ED Safety Checklist with broad applicability across different international ED settings. Athree-round modified Delphi consensus processwasconductedwith a multidisciplinary and multinational panel of experts in emergency medicine and patient safety. Initial checklist items were identified through a systematic review of the literature. Each item was evaluated for inclusion in the final checklist during two rounds of web-based surveys and an online consensus meeting. Agreement for inclusion was defined a priori with a threshold of 80% combined agreement. Eighty panel members from 34 countries across all seven world regions participated in the study, with comparable representation from low- and middle-income and high-income countries. The final checklist contains 86 items divided into: (1) a general ED Safety Checklist focused on diagnostic evaluation, patient reassessment, and disposition and (2) five domain-specific ED Safety Checklists focused on handoff, invasive procedures, triage, treatment prescription, and treatment administration. The checklist includes key clinical tasks to prevent medical errors, as well as items to improve communication among ED team members and with patients and their families. This novel ED Safety Checklist defines the essential elements of high-quality ED care and has the potential to ensure their consistent implementation worldwide.

Liver Injury in People With HIV on Antituberculosis and/or Antiretroviral Therapy-Assessing Causality Using the Updated Roussel Uclaf Causality Assessment Method.

We compared performance of the Roussel Uclaf Causality Assessment Method (RUCAM) with multidisciplinary expert panel review in identifying a drug-induced liver injury (DILI) due to antituberculosis therapy (ATT) and/or antiretroviral therapy (ART). Cases were drawn from a prospective registry of hospitalised adults with suspected DILI due to ATT and/or ART in Cape Town, South Africa. Participants had to fulfil American Thoracic Society criteria for ATT interruption (alanine transaminase [ALT] ≥5 times upper limit of normal [ULN]/ALT ≥3 times [ULN] and symptomatic). Causality assessment by expert panel review served as reference standard. The panel ranked potentially implicated drugs as certain, probable, possible or unlikely causes guided by World Health Organization Uppsala Monitoring Centre criteria. The RUCAM was performed for each potentially implicated drug. We calculated sensitivity and specificity of the RUCAM in identifying a probable/certain drug cause for liver injury. We included 48 participants. All were people with HIV (PWH). Twenty-seven were on concomitant ART and ATT, with a median of six potentially hepatotoxic drugs per case. Sensitivity and specificity of the RUCAM in identifying a probable/certain drug cause of liver injury compared with expert panel review was 7% and 100% respectively. Implicated drugs (times ranked probable/certain by panel) were isoniazid (18/0), pyrazinamide (17/0), rifampicin (15/1), efavirenz (6/4) and lopinavir/ritonavir (1/0). PWH with liver injury received multiple potentially implicated drugs, which may increase liver injury risk and complicate causality assessment. Compared with expert panel review, the RUCAM had low sensitivity in detecting probable or certain drug causes of liver injury.

Recommended Guidelines for Screening for Underlying Malignancy in Extramammary Paget's Disease Based on Anatomic Subtype

IntroductionExtramammary Paget’s disease (EMPD) may be associated with an underlying internal adenocarcinoma, referred to as secondary EMPD. Differences in this association by EMPD anatomic subtype and implications for screening are not fully understood. ObjectiveDefine the rates of secondary EMPD and types of associated adenocarcinomas by EMPD anatomic subtype and propose a screening algorithm for underlying adenocarcinoma. MethodsSystematic literature review of EMPD (January 1990- November 2022). One hundred twenty-two studies met the inclusion criteria. A multidisciplinary expert panel reviewed the recommendation statements on adenocarcinoma screening. ResultsPerianal EMPD was associated with a high rate of underlying adenocarcinoma (25%, primarily colorectal) compared with penoscrotal and vulvar EMPD (6% each, primarily of genitourinary origin). Thorough screening in perianal EMPD includes a colonoscopy, urine cytology, and computed tomography (CT) of the chest, abdomen and pelvis. Cost-conscious screening tests in low-risk penoscrotal disease include urine cytology, heme-occult test, and prostate-specific antigen test (especially if under 70 years of age). For low-risk vulvar EMPD, urine cytology and mammography are recommended. EMPD with high-risk features may warrant more sensitive organ-specific testing. LimitationsSelection bias; retrospective data without systematic follow-up. ConclusionsScreening for underlying adenocarcinoma in EMPD should be guided by anatomic location.

Drug Interactions between Androgen Receptor Axis-Targeted Therapies and Antithrombotic Therapies in Prostate Cancer: Delphi Consensus.

Background/Objectives: Abiraterone acetate, apalutamide, darolutamide, and enzalutamide, which make up the androgen receptor axis-targeted therapies (ARATs) drug class, are commonly used in the management of prostate cancer. Many patients on ARATs also receive oral antithrombotic therapy (i.e., anticoagulants or antiplatelets). The concomitant use of ARATs and antithrombotic therapies creates the potential for clinically relevant drug-drug interactions, but the literature regarding the actual consequences of these interactions, and guidance for co-prescribing, is limited. We assembled a multidisciplinary panel of experts and provided them with clinical information derived from a comprehensive literature review regarding the drug-drug interactions between ARATs and antithrombotic therapies. Methods: A three-stage modified electronic Delphi process was used to gather and consolidate opinions from the panel. Each stage consisted of up to three rounds of voting to achieve consensus on which ARAT/antithrombotic therapy drug pairs warrant attention, the possible clinical consequences of drug-drug interactions, and suggested actions for management. Results: The panel achieved consensus to avoid 11 ARAT/antithrombotic therapy drug pairs and modify therapy for eight pairs. Assessments relied heavily on pharmacokinetic data and extrapolation from drug-drug interaction studies of similarly metabolized drugs. Conclusions: This e-Delphi process highlights the need for further research into the clinical impact of ARAT/antithrombotic drug interactions. Nonetheless, the suggested actions aim to provide clinicians with a practical framework for therapeutic decision making.

Therapeutic implications of homologous repair deficiency testing in patients with prostate cancer (Part 2 of 2).

Unfortunately, not all metastatic castration-resistant prostate cancer (mCRPC) patients receive available life-prolonging systemic therapies, emphasizing the need to optimize mCRPC treatment selections. Better guidelines are necessary to determine genetic testing for prostate cancer. In this two-part expert opinion-based guide, we provide an expert consensus opinion on the utilization of germline and somatic testing to detect HRR alterations in patients with mCRPC. This guide was developed by a multidisciplinary expert panel that convened in 2023-2024, including representatives from medical oncology, urology, radiation oncology, pathology, medical genomics, and basic science. In this second part, we highlight how genetic testing can lead to improved, life-prolonging mCRPC therapeutic strategies based on a review of the recent phase III trials and subsequent regulatory approvals for PARP inhibitors in mCRPC.

Artificial intelligence and social accountability in the Canadian health care landscape: A rapid literature review.

Situated within a larger project entitled "Exploring the Need for a Uniquely Different Approach in Northern Ontario: A Study of Socially Accountable Artificial Intelligence," this rapid review provides a broad look into how social accountability as an equity-oriented health policy strategy is guiding artificial intelligence (AI) across the Canadian health care landscape, particularly for marginalized regions and populations. This review synthesizes existing literature to answer the question: How is AI present and impacted by social accountability across the health care landscape in Canada? A multidisciplinary expert panel with experience in diverse health care roles and computer sciences was assembled from multiple institutions in Northern Ontario to guide the study design and research team. A search strategy was developed that broadly reflected the concepts of social accountability, AI and health care in Canada. EMBASE and Medline databases were searched for articles, which were reviewed for inclusion by 2 independent reviewers. Search results, a description of the studies, and a thematic analysis of the included studies were reported as the primary outcome. The search strategy yielded 679 articles of which 36 relevant studies were included. There were no studies identified that were guided by a comprehensive, equity-oriented social accountability strategy. Three major themes emerged from the thematic analysis: (1) designing equity into AI; (2) policies and regulations for AI; and (3) the inclusion of community voices in the implementation of AI in health care. Across the 3 main themes, equity, marginalized populations, and the need for community and partner engagement were frequently referenced, which are key concepts of a social accountability strategy. The findings suggest that unless there is a course correction, AI in the Canadian health care landscape will worsen the digital divide and health inequity. Social accountability as an equity-oriented strategy for AI could catalyze many of the changes required to prevent a worsening of the digital divide caused by the AI revolution in health care in Canada and should raise concerns for other global contexts.

Encuesta nacional y elaboración de un documento de consenso sobre estrategias de dosificación de antibióticos beta-lactámicos frente a bacterias gramnegativas multirresistentes (BGN-MDR) en pacientes críticos sometidos a técnicas de soporte vital extracorpóreas: protocolo de estudio DOSEBL

IntroductionInfections caused by multidrug-resistant gram-negative bacilli (MDR-GNB) in critically ill patients present a challenge for timely and appropriate antibiotic treatment. This is particularly important in patients undergoing extracorporeal life support techniques such as renal replacement therapy and extracorporeal membrane oxygenation. These techniques can introduce additional pharmacokinetic alterations, potentially leading to suboptimal exposure to antibiotics. This study aims to outline dosing strategies and therapeutic drug monitoring protocols for new β-lactam antibiotics effective against MDR-GNB in critically ill patients undergoing extracorporeal life support techniques at a national level. Additionally, the study seeks to develop a consensus document, based on available evidence. MethodsThe project will comprise two main phases: I) A national survey, and II) the development of a consensus document. This consensus document, undertaken according to ACCORD guidelines, will encompass: a) establishment of a multidisciplinary panel of experts, b) prospective registration of the consensus, c) evidence synthesis, d) modified Delphi rounds. The antimicrobials to be included will be: meropenem, ceftazidime/avibactam, ceftolozane/tazobactam, cefiderocol, meropenem/vaborbactam, imipenem/relebactam, and aztreonam. Extracorporeal life support techniques will include continuous renal replacement therapy, conventional intermittent hemodialysis, and extracorporeal membrane oxygenation. DiscussionThe availability of extracorporeal life support techniques has expanded significantly in recent years, alongside a rise in the prevalence of infections caused by multidrug-resistant gram-negative bacilli (MDR-GNB). There is a need to develop evidence-based tools of high quality to standardize dosing and monitoring strategies for new β-lactam antibiotics.

590. RESOLUTION OF SYMPTOMS AFTER OESOPHAGO-GASTRIC CANCER RESECTION (RESTORED)–STANDARDISING GASTROINTESTINAL SYMPTOMS AND CONDITIONS AFTER SURGERY: A MULTI-DISCIPLINARY EXPERT DELPHI STUDY

Abstract Background Oesophago-gastric cancer surgery negatively affects quality of life with a high post-operative symptom burden. Several conditions that may be diagnosed and treated after surgery are recognised. However, consensus regarding their definition and management is lacking. We aimed to develop consensus regarding the definition, investigation and management of the common symptoms and conditions, and triggers to consider disease recurrence, as a foundation for improving management and quality of life in these patients. Design Modified 2-round Delphi consensus study of a multidisciplinary expert panel. Results 86/127(67.7%) and 77/100(77.0%) responses were received in rounds 1 and 2. Consensus was achieved in defining 26 symptoms. For 10 conditions (anastomotic stricture, acid reflux, non-acid reflux, biliary gastritis, delayed gastric emptying, dumping syndrome, exocrine pancreatic insufficiency, bile acid diarrhoea, small intestinal bacterial overgrowth and carbohydrate malabsorption), definitions, diagnostic criteria, first and second-line investigation and first-line treatments were agreed. Consensus was not reached for third line investigation of some conditions, nor for second, third or fourth-line treatments for others. 12 of 14(85.7%) symptoms were agreed as triggers to consider cancer recurrence, during the early (< 1 year) and late (> 1 year) post-operative periods. Conclusion Expert consensus regarding symptoms, conditions and triggers to consider investigation for recurrence after oesophago-gastric cancer surgery was achieved. This will allow standardisation and timely diagnosis and treatment of post-operative conditions, reducing variation in care. It will facilitate comparative, prospective research to establish the incidence and response to treatment of these conditions, helping develop robust evidence to optimise patients’ quality of life.

The Benchmarking Exercise Programme for Older People (BEPOP): Design, Results and Recommendations from The First Wave of Data Collection.

The Benchmarking Exercise Programme for Older People (BEPOP) service improvement project seeks to determine and promote the exercise training characteristics associated with positive outcomes for resistance exercise for older people living with, or at risk of, sarcopenia or physical frailty. Mixed-methods service improvement project. Ten UK National Health Service physiotherapist-led therapy services delivering exercise interventions for older people submitted anonymized data for up to 20 consecutive patients. A multidisciplinary expert panel generated a report and recommendations with site-specific benchmarking data and feedback. In parallel, participating physiotherapy team members were interviewed to elicit feedback on BEPOP rationale, processes and perceived value. Data from 188 patients were included, mean age 80 years (range 60-101). 115 (61%) received objective assessment of strength-based physical performance. Bodyweight exercises (173 [92%]) and resistance bands (49 [26%]) were the commonest exercise modalities. Exercises progressed predominantly through increased repetitions (163 [87%]) rather than increased load. 50 (30%) had no reassessment of outcomes; only 68 (41%) were signposted to follow-on exercise services. Staff interviews identified themes around knowledge, diagnosis, data collection and practice reflection. BEPOP was feasible to deliver and generated actionable insights for service improvement via improved diagnosis, measurement and progression of resistance exercise.

Generation and content validation of physical and vocational rehabilitation in paraplegics: An interview guide

BACKGROUND: As the mainstay treatment for paraplegics is rehabilitation, patient satisfaction and experience are important predictors of the care being provided. To understand whether the current arrangements of rehabilitation services are sufficient to help an individual with paraplegia return to a productive life. Patient-centered interview guides to explore their rehabilitation experience are lacking, which calls for a generation of the same. OBJECTIVE: To generate and validate an interview guide (PVR-PIG), which aims at understanding and exploring the experience of physical and vocational rehabilitation for individuals with paraplegia. METHODS: After an extensive literature search, an initial 27-item interview guide was formulated under three domains: general experience and expectations from rehabilitation care; physical rehabilitation experience, barriers, and facilitators; and vocational rehabilitation. Later, it was sent for content validation to a multidisciplinary expert panel with prior experience in spinal cord injury (SCI) management. RESULTS: After suggestions were received from nine experts with an average of 14 years of experience in dealing with SCI, a 15-item interview guide was finalized, with a scale-level and item-level content validity index of 0.897 and 0.78–1, respectively. CONCLUSION: The generated interview guide (PVR-PIG) aimed to explore physical and vocational rehabilitation experiences in paraplegics was found to be valid.

The implementation of exercise therapy within hospital-based mental healthcare: Delphi study.

The physical health comorbidities and premature mortality experienced by people with mental illness has led to an increase in exercise services embedded as part of standard care in hospital-based mental health services. Despite the increase in access to exercise services for people experiencing mental illness, there is currently a lack of guidelines on the assessment and triage of patients into exercise therapy. To develop guidelines for the pre-exercise screening and health assessment of patients engaged with exercise services in hospital-based mental healthcare and to establish an exercise therapy triage framework for use in hospital-based mental healthcare. A Delphi technique consisting of two online surveys and two rounds of focus group discussions was used to gain consensus from a multidisciplinary panel of experts. Consensus was reached on aspects of pre-exercise health screening, health domain assessment, assessment tools representing high-value clinical assessment, and the creation and proposed utilisation of an exercise therapy triage framework within exercise therapy. This study is the first of its kind to provide guidance on the implementation of exercise therapy within Australian hospital-based mental healthcare. The results provide recommendations for appropriate health assessment and screening of patients in exercise therapy, and provide guidance on the implementation and triage of patients into exercise therapy via a stepped framework to determine (a) the timeliness of exercise therapy required and (b) the level of support required in the delivery of their exercise therapy.

European Society of Clinical Microbiology and Infectious Diseases/European Committee on infection control clinical guidelines on pre-operative decolonization and targeted prophylaxis in patients colonized by multidrug-resistant Gram-positive bacteria before surgery

ScopeThe aim of these guidelines is to provide recommendations for decolonization and perioperative antibiotic prophylaxis (PAP) in multidrug-resistant Gram-positive bacteria (MDR-GPB) adult carriers before inpatient surgery. MethodsThese European Society of Clinical Microbiology and Infectious Diseases/European Committee on Infection Control guidelines were developed following a systematic review of published studies targeting methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci, methicillin-resistant coagulase-negative Staphylococci, and pan-drug-resistant-GPB. Critical outcomes were the occurrence of surgical site infections (SSIs) caused by the colonizing MDR-GPB and SSIs-attributable mortality. Important outcomes included the occurrence of SSIs caused by any pathogen, hospital-acquired infections, all-cause mortality, and adverse events associated with the interventions, including resistance development to the agents used and the incidence of Clostridioides difficile infections. The last search of all databases was performed on 1 November 2023. The level of evidence and the strength of each recommendation were defined according to the Grading of Recommendations Assessment, Development, and Evaluation approach. Consensus of a multidisciplinary expert panel was reached for the final list of recommendations. Antimicrobial stewardship considerations were included. RecommendationsThe guideline panel reviewed the impact of decolonization, targeted PAP, and combined interventions (e.g. decolonization and targeted PAP) on the risk of SSIs and other outcomes in MDR-GPB carriers, according to the type of bacteria and type of surgery.We recommend screening for S. aureus before high-risk operations, such as cardiothoracic and orthopaedic surgery. Decolonization with intranasal mupirocin with or without a chlorhexidine bath is recommended in patients colonized with S. aureus before cardiothoracic and orthopaedic surgery and suggested in other surgeries. The addition of vancomycin to standard prophylaxis is suggested for MRSA carriers in cardiothoracic surgery, orthopaedic surgery, and neurosurgery. Combined interventions (e.g. decolonization and targeted prophylaxis) are suggested for MRSA carriers undergoing cardiothoracic and orthopaedic surgery. No recommendation could be made regarding screening, decolonization and targeted prophylaxis for vancomycin-resistant enterococci because of the lack of data. No evidence was retrieved for methicillin-resistant coagulase-negative Staphylococci and pan-drug-resistant-GPB. Careful consideration of the laboratory workload and involvement of antimicrobial stewardship and infection control teams are warranted before implementing screening procedures or performing changes in PAP policy. Future research should focus on novel decolonizing techniques, on the monitoring of resistance to decolonizing agents and PAP regimens, and on standardized combined interventions in high-quality studies.

Expert Consensus on the Management of Adverse Events of Lorlatinib in the Treatment of ALK+ Advanced Non-small Cell Lung Cancer.

The use of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), such as lorlatinib, for the treatment of patients with ALK gene rearrangement (or ALK-positive) non-small cell lung cancer (NSCLC) has been shown to improve the overall survival and quality of life of these patients. However, lorlatinib is not exempt from potential adverse events. Adequate monitoring and management of these adverse events are critical for increasing patient adherence to lorlatinib, thereby maximizing the benefits of treatment and minimizing the risks associated with treatment discontinuation. Considering that the adverse events of lorlatinib can affect different organs and systems, the participation of a multidisciplinary team, including cardiologists, neurologists, internal medicine specialists, and oncology pharmacists, is needed. This article presents specific and pragmatic strategies for identifying and treating the most relevant adverse events associated with lorlatinib in patients with advanced ALK-positive NSCLC based on the clinical experience of a multidisciplinary panel of experts.

SAGES guidelines for the surgical treatment of hiatal hernias.

Hiatal hernia (HH) is a common condition. A multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians, patients, and others in decisions regarding the treatment of HH. Systematic reviews were conducted for four key questions regarding the treatment of HH in adults: surgical treatment of asymptomatic HH versus surveillance; use of mesh versus no mesh; performing a fundoplication versus no fundoplication; and Roux-en-Y gastric bypass (RYGB) versus redo fundoplication for recurrent HH. Evidence-based recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluations methodology by subject experts. When the evidence was insufficient to base recommendations on, expert opinion was utilized instead. Recommendations for future research were also proposed. The panel provided one conditional recommendation and two expert opinions for adults with HH. The panel suggested routinely performing a fundoplication in the repair of HH, though this was based on low certainty evidence. There was insufficient evidence to make evidence-based recommendations regarding surgical repair of asymptomatic HH or conversion to RYGB in recurrent HH, and therefore, only expert opinions were offered. The panel suggested that select asymptomatic patients may be offered surgical repair, with criteria outlined. Similarly, it suggested that conversion to RYGB for management of recurrent HH may be appropriate in certain patients and again described criteria. The evidence for the routine use of mesh in HH repair was equivocal and the panel deferred making a recommendation. These recommendations should provide guidance regarding surgical decision-making in the treatment of HH and highlight the importance of shared decision-making and consideration of patient values to optimize outcomes. Pursuing the identified research needs will improve the evidence base and may allow for stronger recommendations in future evidence-based guidelines for the treatment of HH.

Guidelines for management of actual or suspected inadvertent intra-arterial injection of sclerosants.

Inadvertent intra-arterial injection of sclerosants is an uncommon adverse event of both ultrasound-guided and direct vision sclerotherapy. This complication can result in significant tissue or limb loss and significant long-term morbidity. To provide recommendations for diagnosis and immediate management of an unintentional intra-arterial injection of sclerosing agents. An international and multidisciplinary expert panel representing the endorsing societies and relevant specialities reviewed the published biomedical, scientific and legal literature and developed the consensus-based recommendations. Actual and suspected cases of an intra-arterial sclerosant injection should be immediately transferred to a facility with a vascular/interventional unit. Digital Subtraction Angiography (DSA) is the key investigation to confirm the diagnosis and help select the appropriate intra-arterial therapy for tissue ischaemia. Emergency endovascular intervention will be required to manage the risk of major limb ischaemia. This includes intra-arterial administration of vasodilators to reduce vasospasm, and anticoagulants and thrombolytic agents to mitigate thrombosis. Mechanical thrombectomy, other endovascular interventions and even open surgery may be required. Lumbar sympathetic block may be considered but has a high risk of bleeding. Systemic anti-inflammatory agents, anticoagulants, and platelet inhibitors and modifiers would complement the intra-arterial endovascular procedures. For risk of minor ischaemia, systemic oral anti-inflammatory agents, anticoagulants, vasodilators and antiplatelet treatments are recommended. Inadvertent intra-arterial injection is an adverse event of both ultrasound-guided and direct vision sclerotherapy. Medical practitioners performing sclerotherapy must ensure completion of a course of formal training (specialty or subspecialty training, or equivalent recognition) in the management of venous and lymphatic disorders (phlebology), and be personally proficient in the use of duplex ultrasound in vascular (both arterial and venous) applications, to diagnose and provide image guidance to venous procedure. Expertise in diagnosis and immediate management of an intra-arterial injection is essential for all practitioners performing sclerotherapy.