Multidisciplinary Expert Panel Research Articles

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.

Dutch multidisciplinary guideline on anterior knee pain: Patellofemoral pain and patellar tendinopathy.

The purpose of this study was to develop a multidisciplinary guideline for patellofemoral pain (PFP) and patellar tendinopathy (PT) to facilitate clinical decision-making in primary and secondary care. A multidisciplinary expert panel identified questions in clinical decision-making. Based on a systematic literature search, the strength of the scientific evidence was determined according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method and the weight assigned to the considerations by the expert panel together determined the strength of the recommendations. After confirming PFP or PT as a clinical diagnosis, patients should start with exercise therapy. Additional conservative treatments are indicated only when exercise therapy does not result in clinically relevant changes after six (PFP) or 12 (PT) weeks. Pain medications should be reserved for cases of severe pain. The additional value of imaging assessments for PT is limited. Open surgery is reserved for very specific cases of nonresponders to exercise therapy and those requiring additional conservative treatments. Although the certainty of evidence regarding exercise therapy for PFP and PT had to be downgraded ('very low GRADE' and 'low GRADE'), the expert panel advocates its use as the primary treatment strategy. The panel further formulated weaker recommendations regarding additional conservative treatments, pain medications, imaging assessments and open surgery ('very low GRADE' to 'low GRADE' assessment or absence of scientific evidence). This guideline recommends starting with exercise therapy for PFP and PT. The recommendations facilitate clinical decision-making, and thereby optimizing treatment and preventing unnecessary burdens, risks and costs to patients and society. Level V, clinical practice guideline.

Vitamin D for the Prevention of Disease: An Endocrine Society Clinical Practice Guideline.

Numerous studies demonstrate associations between serum concentrations of 25-hydroxyvitamin D (25[OH]D) and a variety of common disorders, including musculoskeletal, metabolic, cardiovascular, malignant, autoimmune, and infectious diseases. Although a causal link between serum 25(OH)D concentrations and many disorders has not been clearly established, these associations have led to widespread supplementation with vitamin D and increased laboratory testing for 25(OH)D in the general population. The benefit-risk ratio of this increase in vitamin D use is not clear, and the optimal vitamin D intake and the role of testing for 25(OH)D for disease prevention remain uncertain. To develop clinical guidelines for the use of vitamin D (cholecalciferol [vitamin D3] or ergocalciferol [vitamin D2]) to lower the risk of disease in individuals without established indications for vitamin D treatment or 25(OH)D testing. A multidisciplinary panel of clinical experts, along with experts in guideline methodology and systematic literature review, identified and prioritized 14 clinically relevant questions related to the use of vitamin D and 25(OH)D testing to lower the risk of disease. The panel prioritized randomized placebo-controlled trials in general populations (without an established indication for vitamin D treatment or 25[OH]D testing), evaluating the effects of empiric vitamin D administration throughout the lifespan, as well as in select conditions (pregnancy and prediabetes). The panel defined "empiric supplementation" as vitamin D intake that (a) exceeds the Dietary Reference Intakes (DRI) and (b) is implemented without testing for 25(OH)D. Systematic reviews queried electronic databases for publications related to these 14 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and guide recommendations. The approach incorporated perspectives from a patient representative and considered patient values, costs and resources required, acceptability and feasibility, and impact on health equity of the proposed recommendations. The process to develop this clinical guideline did not use a risk assessment framework and was not designed to replace current DRI for vitamin D. The panel suggests empiric vitamin D supplementation for children and adolescents aged 1 to 18 years to prevent nutritional rickets and because of its potential to lower the risk of respiratory tract infections; for those aged 75 years and older because of its potential to lower the risk of mortality; for those who are pregnant because of its potential to lower the risk of preeclampsia, intra-uterine mortality, preterm birth, small-for-gestational-age birth, and neonatal mortality; and for those with high-risk prediabetes because of its potential to reduce progression to diabetes. Because the vitamin D doses in the included clinical trials varied considerably and many trial participants were allowed to continue their own vitamin D-containing supplements, the optimal doses for empiric vitamin D supplementation remain unclear for the populations considered. For nonpregnant people older than 50 years for whom vitamin D is indicated, the panel suggests supplementation via daily administration of vitamin D, rather than intermittent use of high doses. The panel suggests against empiric vitamin D supplementation above the current DRI to lower the risk of disease in healthy adults younger than 75 years. No clinical trial evidence was found to support routine screening for 25(OH)D in the general population, nor in those with obesity or dark complexion, and there was no clear evidence defining the optimal target level of 25(OH)D required for disease prevention in the populations considered; thus, the panel suggests against routine 25(OH)D testing in all populations considered. The panel judged that, in most situations, empiric vitamin D supplementation is inexpensive, feasible, acceptable to both healthy individuals and health care professionals, and has no negative effect on health equity. The panel suggests empiric vitamin D for those aged 1 to 18 years and adults over 75 years of age, those who are pregnant, and those with high-risk prediabetes. Due to the scarcity of natural food sources rich in vitamin D, empiric supplementation can be achieved through a combination of fortified foods and supplements that contain vitamin D.Based on the absence of supportive clinical trial evidence, the panel suggests against routine 25(OH)D testing in the absence of established indications. These recommendations are not meant to replace the current DRIs for vitamin D, nor do they apply to people with established indications for vitamin D treatment or 25(OH)D testing. Further research is needed to determine optimal 25(OH)D levels for specific health benefits.

Prevention and Management of Osteoradionecrosis in Patients With Head and Neck Cancer Treated With Radiation Therapy: ISOO-MASCC-ASCO Guideline.

To provide evidence-based recommendations for prevention and management of osteoradionecrosis (ORN) of the jaw secondary to head and neck radiation therapy in patients with cancer. The International Society of Oral Oncology-Multinational Association for Supportive Care in Cancer (ISOO-MASCC) and ASCO convened a multidisciplinary Expert Panel to evaluate the evidence and formulate recommendations. PubMed, EMBASE, and Cochrane Library databases were searched for randomized controlled trials and observational studies, published between January 1, 2009, and December 1, 2023. The guideline also incorporated systematic reviews conducted by ISOO-MASCC, which included studies published from January 1, 1990, through December 31, 2008. A total of 1,539 publications were initially identified. There were 487 duplicate publications, resulting in 1,052 studies screened by abstract, 104 screened by full text, and 80 included for systematic review evaluation. Due to limitations of available evidence, the guideline relied on informal consensus for some recommendations. Recommendations that were deemed evidence-based with strong evidence by the Expert Panel were those pertaining to best practices in prevention of ORN and surgical management. No recommendation was possible for the utilization of leukocyte- and platelet-rich fibrin or photobiomodulation for prevention of ORN. The use of hyperbaric oxygen in prevention and management of ORN remains largely unjustified, with limited evidence to support its practice.Additional information is available at www.asco.org/head-neck-cancer-guidelines.

CETARS/CAR Practice Guideline on Imaging the Pregnant Trauma Patient.

Imaging of pregnant patients who sustained trauma often causes fear and confusion among patients, their families, and health care professionals regarding the potential for detrimental effects from radiation exposure to the fetus. Unnecessary delays or potentially harmful avoidance of the justified imaging studies may result from this understandable anxiety. This guideline was developed by the Canadian Emergency, Trauma and Acute Care Radiology Society (CETARS) and the Canadian Association of Radiologists (CAR) Working Group on Imaging the Pregnant Trauma Patient, informed by a literature review as well as multidisciplinary expert panel opinions and discussions. The working group included academic subspecialty radiologists, a trauma team leader, an emergency physician, and an obstetriciangynaecologist/maternal fetal medicine specialist, who were brought together to provide updated, evidence-based recommendations for the imaging of pregnant trauma patients, including patient safety aspects (eg, radiation and contrast concerns) and counselling, initial imaging in maternal trauma, specific considerations for the use of fluoroscopy, angiography, and magnetic resonance imaging. The guideline strives to achieve clarity and prevent added anxiety in an already stressful situation of injury to a pregnant patient, who should not be imaged differently.

Procedural sedation and analgesia in pediatric diagnostic and interventional radiology: An expert DELPHI consensus document developed by the ITALIAN scientific society of anesthesia, analgesia, resuscitation and intensive care (SIAARTI).

Children undergoing diagnostic and interventional radiology procedures often require sedation to achieve immobility and analgesia if the procedure is painful. In the past decades, leading scientific organizations have developed evidence-based guidelines for procedural sedation and analgesia in children outside of the operating room. Their recommendations are being applied to procedural sedation in radiology. However, some questions remain open regarding specific aspects contextualized to the radiology setting, such as elective prone sedation, the urgency of the procedure, when venous access or airway protection is required, and others. To address the unresolved issues of procedural sedation and analgesia in pediatric diagnostic and interventional radiology. An expert panel of pediatricians, pediatric anesthesiologists, intensivists, and neuroradiologists selected topics representative of current controversies and formulated research questions. Statements were developed by reviewing the literature for new evidence, comparing expertise and experience, and expressing opinions. Panelists' agreement with the statements was collected anonymously using the DELPHI method. Twelve evidence-based or expert opinion incorporate are presented, considering risks, benefits, and applicability. This consensus document, developed by a multidisciplinary panel of experts involved in the field, provides statements to improve the quality of decision-making practice in procedural sedation and analgesia in pediatric radiology.

Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards.

To update the ASCO-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location. ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. The standards presented here include clarification and expansion of existing standards to include home administration and other changes in processes of ordering, preparing, and administering antineoplastic therapy; the advent of immune effector cellular therapy; the importance of social determinants of health; fertility preservation; and pregnancy avoidance. In addition, the standards have added a fourth verification. Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors.Additional information is available at www.asco.org/standards and www.ons.org/onf.

Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update.

To update the ASCO guideline on the management of cancer-related fatigue (CRF) in adult survivors of cancer. A multidisciplinary panel of medical oncology, geriatric oncology, internal medicine, psychology, psychiatry, exercise oncology, integrative medicine, behavioral oncology, nursing, and advocacy experts was convened. Guideline development involved a systematic literature review of randomized controlled trials (RCTs) published in 2013-2023. The evidence base consisted of 113 RCTs. Exercise, cognitive behavioral therapy (CBT), and mindfulness-based programs led to improvements in CRF both during and after the completion of cancer treatment. Tai chi, qigong, and American ginseng showed benefits during treatment, whereas yoga, acupressure, and moxibustion helped to manage CRF after completion of treatment. Use of other dietary supplements did not improve CRF during or after cancer treatment. In patients at the end of life, CBT and corticosteroids showed benefits. Certainty and quality of evidence were low to moderate for CRF management interventions. Clinicians should recommend exercise, CBT, mindfulness-based programs, and tai chi or qigong to reduce the severity of fatigue during cancer treatment. Psychoeducation and American ginseng may be recommended in adults undergoing cancer treatment. For survivors after completion of treatment, clinicians should recommend exercise, CBT, and mindfulness-based programs; in particular, CBT and mindfulness-based programs have shown efficacy for managing moderate to severe fatigue after treatment. Yoga, acupressure, and moxibustion may also be recommended. Patients at the end of life may be offered CBT and corticosteroids. Clinicians should not recommend L-carnitine, antidepressants, wakefulness agents, or routinely recommend psychostimulants to manage symptoms of CRF. There is insufficient evidence to make recommendations for or against other psychosocial, integrative, or pharmacological interventions for the management of fatigue.Additional information is available at www.asco.org/survivorship-guidelines.

SAGES guideline for the diagnosis and treatment of appendicitis.

Appendicitis is an extremely common disease with a variety of medical and surgical treatment approaches. A multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians and patients in decisions regarding the diagnosis and treatment of appendicitis. A systematic review was conducted from 2010 to 2022 to answer 8 key questions relating to the diagnosis of appendicitis, operative or nonoperative management, and specific technical and post-operative issues for appendectomy. The results of this systematic review were then presented to a panel of adult and pediatric surgeons. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Conditional recommendations were made in favor of uncomplicated and complicated appendicitis being managed operatively, either delayed (>12h) or immediate operation (<12h), either suction and lavage or suction alone, no routine drain placement, treatment with short-term antibiotics postoperatively for complicated appendicitis, and complicated appendicitis previously treated nonoperatively undergoing interval appendectomy. A conditional recommendation signals that the benefits of adhering to a recommendation probably outweigh the harms although it does also indicate uncertainty. These recommendations should provide guidance with regard to current controversies in appendicitis. The panel also highlighted future research opportunities where the evidence base can be strengthened.

Consensus on the procedure of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension

Chronic thromboembolic pulmonary hypertension (CTEPH) is classified as group IV pulmonary hypertension, characterized by thrombotic occlusion of the pulmonary arteries leading to vascular stenosis or obstruction, progressive increase in pulmonary vascular resistance and pulmonary arterial pressure, and eventual right heart failure. Unlike other types of pulmonary hypertension, the prognosis of CTEPH can be significantly improved by surgery, vascular intervention, and/or targeted drug therapy. Pulmonary endarterectomy (PEA) is the preferred treatment of choice for CTEPH. However, PEA is an invasive procedure with high operative risks, and is currently only performed in a few centers in China. Balloon pulmonary angioplasty (BPA) is an emerging interventional technique for CTEPH, serving as an alternative for patients who are ineligible for PEA or with residual pulmonary hypertension after PEA. BPA is gaining traction in China, but its widespread adoption is limited due to its complexity, operator skills, and equipment requirements, a lack of standard operating procedures and technical guidance, which limit the further improvement and development of BPA in China. To address this, a multidisciplinary panel of experts was convened to develop the Consensus on the Procedure of Balloon Pulmonary Angioplasty for the Chronic Thromboembolic Pulmonary Hypertension, which fomulates guidelines on BPA procedural qualification, perioperative management, procedural planning, technical approach, and complication prevention, with the aim of providing recommendations and clinical guidance for BPA treatment in CTEPH and standardizing its clinical application in this setting. Summary of recommendations: Recommendation 1: It is recommended that physicians who specialize in pulmonary vascular diseases take the lead in formulating the diagnostic and treatment plans for CTEPH, using a multidisciplinary approach.Recommendation 2: Training in BPA technique is critical; novice operators should undergo standardized operative training with at least 50 procedures under the guidance of experienced physicians before embarking on independent BPA procedures.Recommendation 3: BPA requires catheterization labs, angiography systems, standard vascular interventional devices and consumables, drugs, and emergency equipment.Recommendation 4: Patient selection for BPA should consider cardiac and pulmonary function, coagulation status, and comorbid conditions to determine indications and contraindications, thereby optimizing the timing of the procedure and improving safety.Recommendation 5: In experienced centers, patients deemed likely to benefit from early BPA, based on clinical and imaging features of CTEPH and without elevated D-dimer levels, could bypass standard 3-month anticoagulation therapy.Recommendation 6: BPA is a complex interventional treatment that requires thorough pre-operative assessment and preparation.Recommendation 7: The use of perioperative anticoagulants in BPA requires a comprehensive risk assessment of intraoperative bleeding by the operator for individualized decision making.Recommendation 8: A variety of venous access routes are available for BPA; unless contraindicated, the right femoral vein is usually preferred because of its procedural convenience and reduced radiation exposure.Recommendation 9: For the different types of vascular lesion in CTEPH, treatment of ring-like stenoses, web-like lesions, and subtotal occlusions should be prioritized before addressing complete occlusions and tortuous lesions, in order to reduce complications and improve procedural safety.Recommendation 10: A targeted, incremental balloon dilatation strategy based on vascular lesions is recommended for BPA.Recommendation 11: Intravascular pulmonary artery imaging technologies, such as OCT and IVUS can assist in accurate vessel sizing and confirmation of wire placement in the true vascular lumen. Pressure wires can be used to objectively assess the efficacy of dilatation during BPA.Recommendation 12: Endpoints for BPA treatment should be individually assessed, taking into account improvements in clinical symptoms, hemodynamics, exercise tolerance, and quality of life.Recommendation 13: Post-BPA routine monitoring of vital signs is essential; anticoagulation therapy should be initiated promptly post-procedure in the absence of complications. In cases of intraoperative hemoptysis, postoperative anticoagulation regimen adjustments should be adjusted according to the bleeding severity.Recommendation 14: If reperfusion pulmonary edema occurs during or after BPA, ensure adequate oxygenation, diuresis, and consider non-invasive positive-pressure ventilation if necessary, while severe cases may require early mechanical ventilation assistance or ECMO.Recommendation 15: In cases of intraoperative hemoptysis, temporary balloon occlusion to stop bleeding is recommended, along with protamine to neutralize heparin. Persistent bleeding may warrant the use of gelatin sponges, coil embolization, or covered stent implantation.Recommendation 16: For contrast imaging during BPA, non-ionic, low or iso-osmolar contrast agents are recommended, with hydration status determined by the patient's clinical condition, cardiac and renal function, and intraoperative contrast volume used.

Preventable trauma deaths in the Western Cape of South Africa: A consensus-based panel review.

Injury causes 4.4 million deaths worldwide annually. 90% of all injury-related deaths occur in low-and-middle income countries. Findings from expert-led trauma death reviews can inform strategies to reduce trauma deaths. A cohort of trauma decedents was identified from an on-going study in the Western Cape Province of South Africa. For each case, demographics, injury characteristics, time and location of death and postmortem findings were collected. An expert multidisciplinary panel of reviewed each case, determined preventability and made recommendations for improvement. Analysis of preventable and non-preventable cases was performed using Chi-square, Fisher's exact, and Wilcoxon signed rank tests. A rapid qualitative analysis of recommendations was conducted and descriptively summarized. 138 deaths (48 deceased-on-scene and 90 pre- or in-hospital deaths) were presented to 23 panelists. Overall, 46 (33%) of deaths reviewed were considered preventable or potentially preventable. Of all pre- and in-hospital deaths, late deaths (>24 hours) were more frequently preventable (22, 56%) and due to multi-organ failure and sepsis, compared to early deaths (≤24 hours) with 32 (63%) that were non-preventable and due to central nervous system injury and haemorrhage. 45% of pre and in-hospital deaths were preventable or potentially preventable. The expert panel recommended strengthening community based primary prevention strategies for reducing interpersonal violence alongside health system improvements to facilitate high quality care. For the health system the panel's key recommendations included improving team-based care, adherence to trauma protocols, timely access to radiology, trauma specialists, operative and critical care.

Ongoing decision-making dilemma for treatment of de novo spinal infections: a comparison of the Spinal Infection Treatment Evaluation Score with the Spinal Instability Spondylodiscitis Score and Spine Instability Neoplastic Score.

De novo spinal infections are an increasing medical problem. The decision-making for surgical or nonsurgical treatment for de novo spinal infections is often a non-evidence-based process and commonly a case-by-case decision by single physicians. A scoring system based on the latest evidence might help improve the decision-making process compared with other purely radiology-based scoring systems or the judgment of a single senior physician. Patients older than 18 years with an infection of the spine who underwent nonsurgical or surgical treatment between 2019 and 2021 were identified. Clinical data for neurological status, pain, and existing comorbidities were gathered and transferred to an anonymous spreadsheet. Patients without an MR image and a CT scan of the affected spine region were excluded from the investigation. A multidisciplinary expert panel used the Spine Instability Neoplastic Score (SINS), Spinal Instability Spondylodiscitis Score (SISS), and Spinal Infection Treatment Evaluation Score (SITE Score), previously developed by the authors' group, on every clinical case. Each physician of the expert panel gave an individual treatment recommendation for surgical or nonsurgical treatment for each patient. Treatment recommendations formed the expert panel opinion, which was used to calculate predictive validities for each score. A total of 263 patients with spinal infections were identified. After the exclusion of doubled patients, patients without de novo infections, or those without CT and MRI scans, 123 patients remained for the investigation. Overall, 70.70% of patients were treated surgically and 29.30% were treated nonoperatively. Intraclass correlation coefficients (ICCs) for the SITE Score, SINS, and SISS were 0.94 (95% CI 0.91-0.95, p < 0.01), 0.65 (95% CI 0.91-0.83, p < 0.01), and 0.80 (95% CI 0.91-0.89, p < 0.01). In comparison with the expert panel decision, the SITE Score reached a sensitivity of 96.97% and a specificity of 81.90% for all included patients. For potentially unstable and unstable lesions, the SISS and the SINS yielded sensitivities of 84.42% and 64.07%, respectively, and specificities of 31.16% and 56.52%, respectively. The SITE Score showed higher overall sensitivity with 97.53% and a higher specificity for patients with epidural abscesses (75.00%) compared with potentially unstable and unstable lesions for the SINS and the SISS. The SITE Score showed a significantly higher agreement for the definitive treatment decision regarding the expert panel decision, compared with the decision by a single physician for patients with spondylodiscitis, discitis, or spinal osteomyelitis. The SITE Score shows high sensitivity and specificity regarding the treatment recommendation by a multidisciplinary expert panel. The SITE Score shows higher predictive validity compared with radiology-based scoring systems or a single physician and demonstrates a high validity for patients with epidural abscesses.

Methodological proposals for developing trustworthy recommendations of integrative Chinese-Western medicine

BackgroundTo refine the methods of developing clinical practice guidelines (CPGs) for integrative Chinese-Western medicine (ICWM), promoting the formation of trustworthy, implementable recommendations that integrate the strengths of Chinese and Western medicine. MethodsUsing a nominal group technique (NGT) approach, a multidisciplinary expert panel was established. The panel identified key methodological issues in ICWM-CPG development through literature review and iterative discussions, and formulated methodological proposals to address these issues. The final set of proposals was achieved through consensus among the panel members. ResultsThe collaborative effort resulted in the identification of five pivotal methodological issues and the subsequent establishment of 22 specific recommendations. These encompass strict adherence to renowned standards, such as those proposed by the Institute of Medicine (IOM) and Guidelines International Network (G-I-N), the employment of methodologies like the GRADE approach and RIGHT statement, the strategic constitution of a balanced development group, the adept identification of ICWM-focused clinical inquiries, the nuanced integration of diverse evidence sources, and the detailed crafting of transparent, implementable recommendations. ConclusionsThis study concentrates on the most crucial and prevalent methodological issues in ICWM-CPG development, proposing a series of recommendations. These suggestions result from a multidisciplinary expert consensus, aiming to provide methodological guidance for ICWM-CPG developers, building upon the current foundational methodologies.

Stakeholder Perspectives of PATH (Plan for Appropriate Tailored Healthcare in Pregnancy) Telemedicine Recommendations [ID 2683565

INTRODUCTION: The COVID-19 pandemic has propelled innovation in prenatal care delivery including use of telemedicine for routine prenatal visits. The Plan for Appropriate Tailored Healthcare in Pregnancy (PATH), a consensus-based prenatal care recommendation developed by a multidisciplinary panel of prenatal care experts, includes two recommendations regarding telemedicine: 1) telemedicine should be an option for all visits aside from four key in-person contacts requiring in-person visits; and 2) home monitoring is an appropriate option for most routine parameters during pregnancy. A national listening tour was conducted to elicit stakeholder feedback for incorporating telemedicine recommendations into practice. METHODS: We conducted nine, 120-minute virtual focus groups with more than 25 organizations including professional (8), patient advocacy (8), public health (5), and payer groups (4). Focus groups were transcribed, coded by recommendation. Data were next analyzed with matrix coding across positive attitudes, negative attitudes, and implementation considerations. RESULTS: Focus groups included 110 participants. Most participants supported telemedicine use as a care modality for routine prenatal care. Positive attitudes included the belief that telemedicine increased care flexibility, care access, and patients' health agency. Negative attitudes included concerns that poor digital literacy, insufficient access to devices, and high cost could perpetuate existing health disparities. Implementation considerations included the importance of relationship building with patients, technical support staff use, home monitoring device validation, and patient education on telehealth best practices. Participants also emphasized needed improvements to telehealth infrastructure and funding. CONCLUSION: Interprofessional stakeholders broadly support telemedicine use in routine prenatal care. Improvements in existing advocacy efforts, research, and infrastructure in underserved communities are needed to facilitate increased access to telemedicine.

Stakeholder Implementation Considerations for PATH (Plan for Appropriate Tailored Healthcare in Pregnancy) Social Needs Recommendations [ID 2683568

INTRODUCTION: Unmet social needs negatively affect health care access and outcomes, and are disproportionately experienced by groups marginalized by racism, socioeconomic status, and geography. The Plan for Appropriate Tailored Healthcare in Pregnancy (PATH), a consensus-based prenatal care recommendation developed by a multidisciplinary panel of prenatal care experts, includes two recommendations regarding social needs: 1) early screening for medical and social determinants of health; and 2) management of social needs in prenatal care. A national listening tour was conducted to capture stakeholder feedback for implementing social needs recommendations into practice. METHODS: We conducted nine, 120-minute virtual focus groups with more than 25 organizations including professional (8), patient advocacy (8), public health (5), and payer groups (4). Focus groups were transcribed, coded by recommendation, and analyzed with matrix coding across patient, clinic, and policy level implementation considerations. RESULTS: Focus groups included 110 participants. Patient-level considerations for implementation included the importance of relationship building, shared decision-making, resources-first screening, and delivery of trauma-informed, culturally concordant care. On the clinic level, participants stressed robust clinic-level processes for providing effective social needs care, including multidisciplinary care navigation, social needs toolkit utilization, dynamic patient needs assessments, and provision of closed-loop referrals. Policy-level considerations included the need for improved provider incentives, interprofessional group collaboration, evidence-based research, and social needs infrastructure. CONCLUSION: Key considerations for implementing social needs care at the individual, clinic, and policy levels must be operationalized for successful integration into routine prenatal care. Further evidence is needed to identify and test the best approaches to addressing unmet social needs across practice settings.

The impact of screen use on sleep health across the lifespan: A National Sleep Foundation consensus statement.

To achieve consensus on whether screen-based digital media (1) in general, (2) via prebedtime content, and (3) via prebedtime light impairs sleep health in (a) childhood, (b) adolescence, and (c) adulthood. Furthermore, to address whether employing behavioral strategies and interventions may reduce the potential negative effects of screens on sleep health. The National Sleep Foundation convened a 16-person multidisciplinary expert panel ("Panel"). Panelists met virtually 5 times throughout 2023, during which they followed a modified Delphi RAND/UCLA Appropriateness Method to reach consensus. The Panel conducted a literature review starting with 2209 articles, narrowed down to 522 relevant empirical articles and 52 relevant review articles. The search was refined to include 35 experimental/intervention studies that examined whether there was a causal link between screen-based digital media and sleep. In addition, panelists reviewed 5 recent relevant systematic review articles. After reviewing the summarized current literature, panelists voted on 10 candidate statements about whether screen use impairs sleep health. The Panel met virtually to discuss the results of the first round of votes, which was then followed by a second round of voting, ultimately achieving consensus on 5 out of the 10 statements. The Panel achieved consensus that (1) in general, screen use impairs sleep health among children and adolescents, (2) the content of screen use before sleep impairs sleep health of children and adolescents, and (3) behavioral strategies and interventions may attenuate the negative effects of screen use on sleep health.

A Radiation Therapy Contouring Atlas for Delineation of the Level I and II Axillae in the Prone Position: A Single-Institution Experience

With transition from supine to prone position, tenting of the pectoralis major occurs, displacing the muscle from the chest wall and shifting the level I and II axillary spaces. For patients for whom we aim to treat the level I and II axillae using the prone technique, accurate delineation of these nodal regions is necessary. Although different consensus guidelines exist for delineation of nodal anatomy in supine position, to our knowledge, there are no contouring guidelines in the prone position that account for this change in nodal anatomy. The level I and II nodal contours from the Radiation Therapy Oncology Group (RTOG) breast cancer supine atlas were adapted for prone position by 2 radiation oncologists and a breast radiologist based on anatomic changes observed from supine to prone positioning on preoperative diagnostic imaging. Forty-three patients from a single institution treated with prone high tangents from 2012 to 2018 were identified as representative cases to delineate the revised level I and II axillae on noncontrast computed tomography (CT) scans obtained during radiation simulation. The revised nodal contours were reviewed by an expanded expert multidisciplinary panel including breast radiologists, radiation oncologists, and surgical oncologists for consistency and reproducibility. Consensus was achieved among the panel in order to create modifications from the RTOG breast atlas for CT-based contouring of the level I and II axillae in prone position using bone, muscle, and skin as landmarks. This atlas provides representative examples and accompanying descriptions for the changes described to the caudal and anterior borders of level II and the anterior, posterior, medial, and lateral borders of level I. A step-by-step guide is provided for properly identifying the revised anterior border of the level I axilla. The adaptations to the RTOG breast cancer atlas for prone positioning will enable radiation oncologists to more accurately target the level I and II axillae when the axillae are targets in addition to the breast.

A Master Protocol Template for Pediatric ARDS Studies.

Pediatric ARDS is associated with significant morbidity and mortality. High-quality data from clinical trials in children are limited due to numerous barriers to their design and execution. Here we describe the collaborative development of a master protocol as a tool to address some of these barriers and support the conduct of pediatric ARDS studies. Using PubMed, we performed a literature search of randomized controlled trials (RCTs) in pediatric ARDS to characterize the current state and evaluate potential benefit of harmonized master protocols. We used a multi-stakeholder, collaborative, and team science-oriented process to develop a master protocol template with links to common data elements (CDEs) for pediatric ARDS trials. We identified 11 RCTs that enrolled between 14-200 total subjects per trial. Interventions included mechanical ventilation, prone positioning, corticosteroids, and surfactant. Studies displayed significant heterogeneity in ARDS definition, design, inclusion and exclusion criteria, and reported outcomes. Mortality was reported in 91% of trials and ventilator-free days in 73%. The trial heterogeneity made pooled analysis unfeasible. These findings underscore the need for a method to facilitate combined analysis of future trials through standardization of trial elements. As a potential solution, we developed a master protocol, iteratively revised with input from a multidisciplinary panel of experts and organized into 3 categories: instructions and general information, templated language, and a series of text options of common pediatric ARDS trial scenarios. Finally, we linked master protocol sections to relevant CDEs previously defined for pediatric ARDS and captured in a series of electronic case report forms. The majority of pediatric ARDS trials identified were small and heterogeneous in study design and outcome reporting. Using a master protocol template for pediatric ARDS trials with CDEs would support combining and comparing pediatric ARDS trial findings and increase the knowledge base.

Adjunctive immunotherapeutic agents in patients with sepsis and septic shock: a multidisciplinary consensus of 23

BackgroundIn the last decades, several adjunctive treatments have been proposed to reduce mortality in septic shock patients. Unfortunately, mortality due to sepsis and septic shock remains elevated and NO trials evaluating adjunctive therapies were able to demonstrate any clear benefit. In light of the lack of evidence and conflicting results from previous studies, in this multidisciplinary consensus, the authors considered the rational, recent investigations and potential clinical benefits of targeted adjunctive therapies.MethodsA panel of multidisciplinary experts defined clinical phenotypes, treatments and outcomes of greater interest in the field of adjunctive therapies for sepsis and septic shock. After an extensive systematic literature review, the appropriateness of each treatment for each clinical phenotype was determined using the modified RAND/UCLA appropriateness method.ResultsThe consensus identified two distinct clinical phenotypes: patients with overwhelming shock and patients with immune paralysis. Six different adjunctive treatments were considered the most frequently used and promising: (i) corticosteroids, (ii) blood purification, (iii) immunoglobulins, (iv) granulocyte/monocyte colony-stimulating factor and (v) specific immune therapy (i.e. interferon-gamma, IL7 and AntiPD1). Agreement was achieved in 70% of the 25 clinical questions.ConclusionsAlthough clinical evidence is lacking, adjunctive therapies are often employed in the treatment of sepsis. To address this gap in knowledge, a panel of national experts has provided a structured consensus on the appropriate use of these treatments in clinical practice.

Human milk and breastfeeding during ketogenic diet therapy in infants with epilepsy: Clinical practice guideline.

Ketogenic diet therapy (KDT) is a safe and effective treatment for epilepsy and glucose transporter type 1 (GLUT1) deficiency syndrome in infancy. Complete weaning from breastfeeding is not required to implement KDT; however, breastfeeding remains uncommon. Barriers include feasibility concerns and lack of referrals to expert centres. Therefore, practical strategies are needed to help mothers and professionals overcome these barriers and facilitate the inclusion of breastfeeding and human milk during KDT. A multidisciplinary expert panel met online to address clinical concerns, systematically reviewed the literature, and conducted two international surveys to develop an expert consensus of practical recommendations for including human milk and breastfeeding in KDT. The need to educate about the nutritional benefits of human milk and to increase breastfeeding rates is emphasized. Prospective real-world registries could help to collect data on the implementation of breastfeeding and the use of human milk in KDT, while systematically including non-seizure-related outcomes, such as quality of life, and social and emotional well-being, which could improve outcomes for infants and mothers.