Reporting bone marrow biopsies for myelodysplastic neoplasms and acute myeloid leukaemia incorporating WHO 5th edition and ICC 2022 classification systems: ALLG/RCPA joint committee consensus recommendations.

The classification of myeloid neoplasms continues to evolve along with advances in molecular diagnosis, risk stratification and treatment of disease. An approach for disease classification has been grounded in international consensus that has facilitated understanding, identification and management of molecularly heterogeneous entities, as well as enabled consistent patient stratification into clinical trials and clinical registries over time. The new World Health Organization (WHO) and International Consensus Classification (ICC) Clinical Advisory Committee releasing separate classification systems for myeloid neoplasms in 2022 precipitated some concern amongst haematopathology colleagues both locally and internationally. While both classifications emphasise molecular disease classification over the historical use of morphology, flow cytometry and cytogenetic based diagnostic methods, notable differences exist in how morphological, molecular and cytogenetic criteria are applied for defining myelodysplastic neoplasms (MDS) and acute myeloid leukaemias (AML). Here we review the conceptual advances, diagnostic nuances, and molecular platforms required for the diagnosis of MDS and AML using the new WHO and ICC 2022 classifications. We provide consensus recommendations for reporting bone marrow biopsies. Additionally, we address the logistical challenges encountered implementing these changes into routine laboratory practice in alignment with the National Pathology Accreditation Advisory Council reporting requirements for Australia and New Zealand.

[Results of the first All-Russian consensus conference on bariatric surgery]. / Rezul'taty pervoi vserossiiskoi konsensus-konferentsii po bariatricheskoi khirurgii.

Until now, there has not been organized consensus for standardization in bariatric surgery In Russia. We present the results of the first Bariatric Surgery Consensus Conference conducted in Barnaul (March, 2023). A list of questions was proposed within 6 blocks: 1) general issues of bariatric surgery, 2) sleeve gastrectomy, 3) one-anastomosis gastric bypass («mini-gastric bypass¼), 4) Roux-en-Y Gastric Bypass, 5) Single Anastomosis Duodenal Switch and other options for biliopancreatic bypass, 6) rare procedures. Consensus (>70% agreement) was reached for 51 out of 96 statements. Stratification by the level of expertise was carried out, and responses of the expert group were compared with responses of all participants.

The Future of Basic Science: Development of the Next Generation of Mechanistic Researchers in Female Pelvic Medicine.

INTRODUCTION AND HYPOTHESIS: The International Urogynecological Association (IUGA) brought together senior and junior members actively engaged in scholarly and educational activities for a consensus conference centered on developing a strategy for sustainable training of the next generation of mechanistic researchers in female pelvic medicine. METHODS: Four a priori identified major foci were explored in a half-day virtual consensus conference. Participants included representatives from various countries and disciplines with diverse backgrounds-clinicians, physician-scientists, and basic scientists in the fields of urogynecology, biomechanical engineering, and molecular biology. Following a keynote address, each focus area was first tackled by a dedicated breakout group, led by the Chair(s) of the most relevant IUGA committees. The break-out sessions were followed by an iterative discussion among all attendees to identify mitigating strategies to address the shortage of mechanistic researchers in the field of female pelvic medicine. RESULTS: The major focus areas included: research priorities for IUGA basic science scholar program; viable strategies for sustainable basic science mentorship; core competencies in basic science training; and the challenges of conducting complex mechanistic experiments in low-resource countries. Key gaps in knowledge and core competencies that should be incorporated into fellowship/graduate training were identified, and existing training modalities were discussed. Recommendations were made for pragmatic approaches to increasing the exposure of trainees to learning tools to enable sustainable training of the next generation of basic science researchers in female pelvic medicine worldwide. CONCLUSIONS: The attendees presented multiple perspectives to gain consensus regarding critical areas of need for training future generations of mechanistic researchers. Recommendations for a sustainable Basic Science Scholar Program were developed using IUGA as a platform. The overarching goal of such a program is to ensure a successful bench-to-bedside-and-back circuit in Urogynecology and Pelvic Reconstructive Surgery, ultimately improving lives of millions of women worldwide through scientifically rational effective preventative and therapeutic interventions.

[GMIA-Breast Oncoplastic and Reconstruction Society consensus on operative standards of breast cancer surgery].

OBJECTIVE: The Breast Cancer Surgery Operative Standards Consensus Conference aimed to establish industry technical standards and improve breast cancer surgery practices by addressing controversial and operative breast cancer surgery-related issues in clinical practice.The conference was led by the Breast Oncoplastic and Reconstruction Branch of Guangdong Medical Industry Association (GMIA) and involved 85 breast surgeons with expertise in breast cancer conserving, oncoplastic, and reconstructive surgery.Consensus was reached through 3 meetings.The first meeting brought up the topics of interest, and evidence summaries were presented for debate during the second meeting; the third meeting was held to reach consensus recommendation for selected topics.Pre-defined consensus criteria required that the consensus was reached only when more than 70% of the panelists agreed on the topic.Out of the 57 questions set for voting, 11 operative standards were recommended as Preferred, and one was recommended as Considered.Preferred operative standards included surgical details in breast conserving surgery, mastectomy, reconstructive surgery, surgical treatment of phyllodes tumor.Selected topics that did not reach consensus among the panelists were also discussed.These Preferred operative standards could help guide clinical surgical practice in routine patient care.

Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Multi-stakeholder contribution to the identification of a core outcome set and measurements in implant dentistry (ID-COSM initiative) using the Delphi methodology.

AIM: To obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry using the Delphi methodology and incorporate them into an international consensus defining a core outcome set. MATERIALS AND METHODS: Candidate outcomes in implant dentistry were generated from scientific evidence through five commissioned systematic reviews and from people with lived experience in dental implants (PWLE) through four international focus groups. A steering committee identified stakeholders among representatives from dental professionals, industry-related experts and PWLE. Participants underwent a three-round Delphi survey using a multi-stakeholder approach; they assessed candidate outcomes and additional outcomes identified in the first Delphi round. The process followed the COMET methodology. RESULTS: From the 665 potential outcomes identified in the systematic reviews and 89 in the PWLE focus group, the steering committee selected 100 and organized them into 13 categories, to be included in the first-round questionnaire as candidate outcomes. A total of 99 dental experts, 7 dental-industry-related experts and 17 PWLE participated in the first round, and 11 additional outcomes were added to the second round. There was no attrition between the first and second rounds, where 61 (54.9%) outcomes exceeded the pre-established threshold of agreement. PWLE and experts participated in the third round that applied "a priori" standard filters to distil a list of candidate essential outcomes. CONCLUSION: This Delphi study utilized a standardized, transparent and inclusive methodology and preliminarily validated 13 essential outcomes organized into four core areas. These results informed the final stage of the ID-COSM consensus.

Multi-stakeholder contribution to the identification of a core outcome set and measurements in implant dentistry (ID-COSM initiative) using the Delphi methodology.

AIM: To obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry using the Delphi methodology and incorporate them into an international consensus defining a core outcome set. MATERIALS AND METHODS: Candidate outcomes in implant dentistry were generated from scientific evidence through five commissioned systematic reviews and from people with lived experience in dental implants (PWLE) through four international focus groups. A steering committee identified stakeholders among representatives from dental professionals, industry-related experts and PWLE. Participants underwent a three-round Delphi survey using a multi-stakeholder approach; they assessed candidate outcomes and additional outcomes identified in the first Delphi round. The process followed the COMET methodology. RESULTS: From the 665 potential outcomes identified in the systematic reviews and 89 in the PWLE focus group, the steering committee selected 100 and organized them into 13 categories, to be included in the first-round questionnaire as candidate outcomes. A total of 99 dental experts, 7 dental-industry-related experts and 17 PWLE participated in the first round, and 11 additional outcomes were added to the second round. There was no attrition between the first and second rounds, where 61 (54.9%) outcomes exceeded the pre-established threshold of agreement. PWLE and experts participated in the third round that applied "a priori" standard filters to distil a list of candidate essential outcomes. CONCLUSION: This Delphi study utilized a standardized, transparent and inclusive methodology and preliminarily validated 13 essential outcomes organized into four core areas. These results informed the final stage of the ID-COSM consensus.

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Essential domains, core outcome sets, and measurements to capture benefits and harms of implant dentistry interventions: The ID-COSM initiative.

Consensus on a valid and comprehensive set of outcomes to capture the full benefits and harms of implant dentistry interventions is key for progress towards better clinical guidelines and policy. In this field, outcome research remains fragmented and uses too many different outcomes. Accordingly, such efforts are still unable to cover the full breadth necessary to properly evaluate benefits, harms, and costs. Best practice examples from medicine have inspired the Implant Dentistry Core Outcome Set and Measurements (ID-COSM) initiative that identified four core outcome domain areas (pathophysiology, implant/prosthesis lifespan, life impact, and access to care) and five essential outcomes mandatory for all trials, plus six others that are mandatory in specific circumstances. The innovative multistep approach has combined input from scientific evidence, patients from multiple countries, methodologists, and industry representatives. It is an important step. The ID-COSM consensus aspires to contribute to better adoption of relevant and valid outcomes in trials and enable combining their results in high-quality meta-analyses to support better informed care and policy.

[Wounds caused by vasculitis-Current classification, diagnostics and treatment]. / Wunden durch Vaskulitiden ­ aktuelle Klassifikation, Diagnostik und Therapie.

Wounds of the skin can have very different causes. Especially in clinically atypical or non-healing wounds, the very heterogeneous group of vasculitides is of particularly important differential diagnostic significance. Nowadays, the classification of vasculitis is based on the affected vessels according to the Chapel Hill consensus conference. Thus, potentially any part of the vascular system can be affected. It becomes clear that there is often a risk of systemic diseases with high interdisciplinary relevance.Clinically, the usually very painful wounds in cutaneous vasculitis develop from necrosis and are typically surrounded by an erythematous-livid rim in the florid phase. In addition to clinical inspection, the histopathological examination of biopsies is of particular importance in the usually extensive diagnostic work-up.Therapeutically, adequate wound treatment should always be performed with a focus on pain prevention and infection prophylaxis. In the case of edema, compression therapy also supports wound healing. In addition, it is often necessary to initiate systemic treatment with immunosuppressive or immunomodulating drugs. Whenever possible, causally relevant factors and comorbidities should be diagnosed early and avoided or treated. Otherwise, there is a risk of severe or even fatal disease progression.

Stakeholders' perspectives on transplant metrics: the 2022 Scientific Registry of Transplant Recipients' consensus conference.

In July 2022, the Scientific Registry of Transplant Recipients (SRTR) hosted an innovative, multistakeholder consensus conference to identify information and metrics desired by stakeholders in the transplantation system, including patients, living donors, caregivers, deceased donor family members, transplant professionals, organ procurement organization professionals, payers, and regulators. Crucially, patients, caregivers, living donors, and deceased donor family members were included in all aspects of this conference, including serving on the planning committee, participating in preconference focus groups and learning sessions, speaking at the conference, moderating conference sessions and breakout groups, and shaping the conclusions. Patients constituted 24% of the meeting participants. In this report, we document the proceedings and enumerate 160 recommendations, 10 of which have been highly prioritized. SRTR will use the recommendations to develop new presentations of information and metrics requested by stakeholders to support informed decision-making.

Short Communication: Results of a Consensus Conference on Radiotherapy for Brain and Bone Metastases Within the Interreg-Project TreaT.

BACKGROUND/AIM: Differences between radiotherapy for metastases in Northern Germany and Southern Denmark were previously identified, which led to a consensus conference. PATIENTS AND METHODS: A consensus conference was held between three centers to harmonize radiotherapy regimens for bone and brain metastases. RESULTS: Centers agreed on 1×8 Gy for painful bone metastases in patients with poor or intermediate survival prognoses and 10×3 Gy for favorable-prognosis patients. For complicated bone metastases, 5-6×4 Gy was preferred for poor-prognosis, 10×3 Gy for intermediate-prognosis, and longer-course radiotherapy for favorable-prognosis patients. For ≥5 brain metastases, centers agreed on whole-brain irradiation (WBI) with 5×4 Gy in poor-prognosis and longer-course regimens in other patients. For single brain lesions and patients with 2-4 lesions and intermediate/favorable prognoses, fractionated stereotactic radiotherapy (FSRT) or radiosurgery were recommended. No consensus was reached for 2-4 lesions in poor-prognosis patients; two centers preferred FSRT, one center WBI. Preferred radiotherapy regimens were similar for different age groups including elderly and very elderly patients, but age-specific survival scores were recommended. CONCLUSION: The consensus conference was successful, since harmonization of radiotherapy regimens was achieved for 32 of 33 possible situations.

Reference theories and future perspectives on robot-assisted rehabilitation in people with neurological conditions: A scoping review and recommendations from the Italian Consensus Conference on Robotics in Neurorehabilitation (CICERONE).

BACKGROUND: Robot-based treatments are developing in neurorehabilitation settings. Recently, the Italian National Health Systems recognized robot-based rehabilitation as a refundable service. Thus, the Italian neurorehabilitation community promoted a national consensus on this topic. OBJECTIVE: To conceptualize undisclosed perspectives for research and applications of robotics for neurorehabilitation, based on a qualitative synthesis of reference theoretical models. METHODS: A scoping review was carried out based on a specific question from the consensus Jury. A foreground search strategy was developed on theoretical models (context) of robot-based rehabilitation (exposure), in neurological patients (population). PubMed and EMBASE® databases were searched and studies on theoretical models of motor control, neurobiology of recovery, human-robot interaction and economic sustainability were included, while experimental studies not aimed to investigate theoretical frameworks, or considering prosthetics, were excluded. RESULTS: Overall, 3699 records were screened and finally 9 papers included according to inclusion and exclusion criteria. According to the population investigated, structured information on theoretical models and indications for future research was summarized in a synoptic table. CONCLUSION: The main indication from the Italian consensus on robotics in neurorehabilitation is the priority to design research studies aimed to investigate the role of robotic and electromechanical devices in promoting neuroplasticity.

Deliberative dialogue on euthanasia in girls, boys and adolescents. Prequel to the Cabildo Ciudadano (Citizen Council) carried out in Colombia

Background: To date, there is a lack of published information on the utilization of the Deliberative dialogue methodology and the right to a dignified death in minors under 18 years of age in Colombia and Latin America. Objective: To examine the issue of children and adolescents' entitlement to a dignified death, including the criteria for exclusion, and to formulate a comprehensive plan for pediatric palliative care. A public policy document will be created with the aim of supporting the implementation of Resolution 825/2018. Methods: Participatory Action Research utilizing a Deliberative dialogue methods that has been adapted based on feminist epistemological principles. Results: The outcome of the exercise was the production of a document containing Public Policy recommendations regarding euthanasia in minors and its submission to the Ministry of Health and Social Protection of Colombia a few days prior to the release of the Resolution regulating the right to a dignified death for this population. Additionally, the conclusions of this event enabled the creation of a guide for the implementation of (Cabildos Ciudadanos) Citizen Council, in which girls, boys, and adolescents are included, trans-disciplinarity is encouraged, and feminist epistemological foundations are explored. Conclusions: The deliberative dialogue method may serve as a cost-efficient alternative to replace or complement participatory approaches utilized in the development of public health guidelines and policies.

Antecedentes: En Colombia y Latinoamérica no se cuenta con registros publicados de temas abordados desde los metodos del diálogo deliberativo frente a temas de salud sobre la población pediátrica. Objetivo: El diálogo deliberativo fue utilizado para deliberar sobre el derecho a la muerte digna en niñas, niños y adolescentes, sus criterios de exclusión, y el marco de acción de los cuidados paliativos pediátricos. Métodos: Investigación acción participativa recurriendo a la metodología Deliberative Poll. Resultados: Redacción de un documento de recomendaciones de Política Pública en torno a la eutanasia en población pediátrica y entrega del mismo al Ministerio de Salud y Protección Social de Colombia días previos a la expedición de la Resolución que reglamentó el derecho a morir con dignidad para esta población; así mismo, las conclusiones de este ejercicio posibilitaron la estructuración de una guía metodológica para la realización de Cabildos Ciudadanos en donde se integra a niñas, niños y adolescentes. Conclusiones: el diálogo deliberativo puede constituirse en una alternativa costo-eficiente para reemplazar o complementar metodologías de participación empleadas en la construcción de lineamientos y políticas públicas en salud.

Propuestas para la incorporación del rol de enfermería en la certificación de unidades de espondiloartritis axial. Revisión bibliográfica y consenso entre expertas / Proposals for the Incorporation of the Nursing role in the Certification of Axial Spondyloarthritis Units. Literature Review and Expert Consensus

Objetivo: Analizar el papel de enfermería en el abordaje de la espondiloartritis axial (EspAax) y plantear propuestas que permitan incluir el rol de las consultas de enfermería en reumatología (CER) en la certificación de calidad de las unidades especializadas. Métodos: Revisión sistemática del rol de enfermería en los sistemas de certificación de calidad en el abordaje de la EspAax, seguida de conferencia de consenso con participación de 3enfermeras especializadas en reumatología para determinar elementos que considerar en futuras revisiones de las normas de certificación. Resultados: La revisión sistemática arrojó 5documentos relevantes. Ninguna de las publicaciones revisadas proponía estándares aplicables a la labor asistencial de enfermería en el manejo de pacientes con EspAax, aunque contemplaban actividades propias de este colectivo. Las propuestas consensuadas para incorporar el rol de las CER en las normas de certificación de las unidades monográficas de EspAax incluyeron: equipamientos y recursos básicos, organización, administración de tratamientos farmacológicos y promoción de la adherencia, programas estandarizados para EspAax, consulta telemática para control del paciente estable y promoción de la continuidad asistencial y registro de medidas de resultados informados por los pacientes. Conclusiones: La literatura sobre estándares de calidad y normas de certificación de las unidades monográficas de EspAax es escasa y apenas refleja el papel de las CER en la provisión de una atención de calidad. Las propuestas consensuadas en este trabajo incorporarían las CER en las normas de certificación de calidad. En el futuro, la mayor presencia de CER en España debiera ir acompañada de la actualización de los estándares.(AU)

Objective: To analyse the role of nursing in the approach to axial spondyloarthritis (axSpA) and to make proposals to include the role of rheumatology nursing consultations (RECs) in the quality certification of these specialized units. Methods: A systematic review of the nursing role in quality certification systems in the management of axSpA was conducted. Subsequently a consensus conference was held with the participation of 3rheumatology nurses to determine elements that should be considered in future revisions of certification standards. Results: The systematic review yielded 5papers as relevant. None of the publications reviewed explicitly proposed standards applicable to nursing care in the management of patients with axSpA, although they contemplated the activities of this professional group. The proposals agreed upon to incorporate the role of RECs in the certification standards for axSpA monographic units included the following: basic equipment and resources, organization, administration of pharmacological treatments and promotion of adherence, standardized programmes for axSpA, telematic consultation (e-consultation) for monitoring the stable patient and promoting continuity of care and registry of patient-reported outcome measures. Conclusions: The literature on quality standards and certification standards for axSpA monographic units is scarce and hardly reflects the role of RECs in providing quality care. The consensus proposals in this study would incorporate RECs into quality certification standards. In the future, the increased presence of RECs in Spain should be accompanied by a review of the indicators regarding their role.(AU)

A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER).

INTRODUCTION: Intrathecal therapy has been limited by non-randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of intrathecal polyanalgesic consensus guidelines exist. METHODS: After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator's discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey. RESULTS: Seventy-nine patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroups within the CMM for chronic pain-related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from the baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications. CONCLUSION: This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

Colombian Consensus on the Treatment of Placenta Accreta Spectrum (PAS) / Consenso Colombiano de Tratamiento del Espectro de Acretismo Placentario (EAP)

Introduction: Placenta accreta spectrum (PAS) is a condition associated with massive postpartum bleeding and maternal mortality. Management guidelines published in high income countries recommend the participation of interdisciplinary teams in hospitals with sufficient resources for performing complex procedures. However, some of the recommendations contained in those guidelines are difficult to implement in low and medium income countries. Objectives: The aim of this consensus is to draft general recommendations for the treatment of PAS in Colombia. Materials and methods: Twenty-three panelists took part in the consensus with their answers to 31 questions related to the treatment of PAS. The panelists were selected based on participation in two surveys designed to determine the resolution capabilities of national and regional hospitals. The modified Delphi methodology was used, introducing two successive discussion rounds. The opinions of the participants, with a consensus of more than 80%, as well as implementation barriers and facilitators, were taken into consideration in order to issue the recommendations. Results: The consensus draftedfive recommendations, integrating the answers of the panelists. Recommendation 1. Primary care institutions must undertake active search of PAS in patients with risk factors: placenta praevia and history of myomectomy or previous cesarean section. In case of ultrasound signs suggesting PAS, patients must be immediately referred, without a minimum gestational age, to hospitals recognized as referral centers. Online communication and care modalities may facilitate the interaction between primary care institutions and referral centers for PAS. The risks and benefits of telemedicine modalities must be weighed. Recommendation 2. Referral hospitals for PAS need to be defined in each region of Colombia, ensuring coverage throughout the national territory. It is advisable to concentrate the flow of patients affected by this condition in a few hospitals with surgical teams specifically trained in PAS, availability of specialized resources, and institutional efforts at improving quality of care with the aim of achieving better health outcomes in pregnant women with this condition. To achieve this goal, participants recommend that healthcare regulatory agencies at a national and regional level should oversee the process of referral for these patients, expediting administrative pathways in those cases in which there is no prior agreement between the insurer and the selected hospital or clinic. Recommendation 3. Referral centers for patients with PAS are urged to build teams consisting of a fixed group of specialists (obstetricians, urologists, general surgeons, interventional radiologists) entrusted with the care of all PAS cases. It is advisable for these interdisciplinary teams to use the "intervention bundle" model as a guidance for building PAS referral centers. This model comprises the following activities: service preparedness, disease prevention and identification, response to the occurrence of the disease, and debriefing after every event. Telemedicine facilitates PAS treatment and should be taken into consideration by interdisciplinary teams caring for this disease. Recommendation 4. Obstetrics residents must be instructed in the performance of maneuvers that are useful for the prevention and treatment of massive intraoperative bleeding due to placenta praevia and PAS, including manual aortic compression, uterine tourniquet, pelvic packing, retrovesical bypass, and Ward maneuver. Specialization Obstetrics and Gynecology programs in Colombia must include the basic concepts of the diagnosis and treatment of PAS. Referral centers for PAS must offer online and in-person training programs for professionals interested in improving their competencies in PAS. Moreover, they must offer permanent remote support (telemedicine) to other hospitals in their region for patients with this condition. Recommendation 5. Patients suspected of having PAS and placenta praevia based on imaging, with no evidence of active vaginal bleeding, must be delivered between weeks 34 and 36 6/7. Surgical treatment must include sequential interventions that may vary depending on the characteristics of the lesion, the clinical condition of the patient and the availability of resources. The surgical options (total and subtotal hysterectomy, one-stage conservative surgical management and watchful waiting) must be included in a protocol known by the entire interdisciplinary team. In situations in which an antepartum diagnosis is lacking, that is to say, in the face of intraoperative finding of PAS (evidence of purple bulging or neovascularization of the anterior aspect of the uterus), and the participation of untrained personnel, three options are considered: Option 1: In the absence of indication of immediate delivery or of vaginal delivery, the recommendation is to postpone the cesarean section (close the laparotomy before incising the uterus) until the recommended resources for safe surgery are secured. Option 2: If there is an indication for immediate delivery (e.g., non-reassuring fetal status) but there is absence of vaginal bleeding or indication for immediate PAS management, a two-stage management is suggested: cesarean section avoiding placental incision, followed by uterine repair and abdominal closure, until the availability of the recommended resources for safe surgery is ascertained. Option 3: In the event of vaginal bleeding that prevents definitive PAS management, the fetus must be delivered through the uterine fundus, followed by uterine repair and reassessment of the situation. Sometimes, fetal delivery diminishes placental flow and vaginal bleeding is reduced or disappears, enabling the possibility to postpone definitive management of PAS. In case of persistent significant bleeding, hysterectomy should be performed, using all available resources: manual aortic compression, immediate call to the surgeons with the best available training, telemedicine support from expert teams in other hospitals. If a patient with risk factors for PAS (e.g., myomectomy or previous cesarean section) has a retained placenta after vaginal delivery, it is advisable to confirm the possibility of such diagnosis (by means of ultrasound, for example) before proceeding to manual extraction of the placenta. Conclusions: It is our hope that this first Colombian consensus on PAS will serve as a basis for additional discussions and collaborations that can result in improved clinical outcomes for women affected by this condition. Additional research will be required in order to evaluate the applicability and effectiveness of these recommendations.

Introducción: el espectro de acretismo placentario (EAP) es una condición asociada a sangrado masivo posparto y mortalidad materna. Las guías de manejo publicadas en países de altos ingresos recomiendan la participación de grupos interdisciplinarios en hospitales con recursos suficientes para realizar procedimientos complejos. Sin embargo, algunas de las recomendaciones de estas guías resultan difíciles de aplicar en países de bajos y medianos ingresos. Objetivos: este consenso busca formular recomendaciones generales para el tratamiento del EAP en Colombia. Materiales y métodos: en el consenso participaron 23 panelistas, quienes respondieron 31 preguntas sobre el tratamiento de EAP. Los panelistas fueron seleccionados con base en la participación en dos encuestas realizadas para determinar la capacidad resolutiva de hospitales en el país y la región. Se utilizó la metodología Delphi modificada, incorporando dos rondas sucesivas de discusión. Para emitir las recomendaciones el grupo tomó en cuenta la opinión de los participantes, que lograron un consenso mayor al 80 %, así como las barreras y los facilitadores para su implementación. Resultados: el consenso formuló cinco recomendaciones integrando las respuestas de los panelistas. Recomendación 1. Las instituciones de atención primaria deben realizar búsqueda activa de EAP en pacientes con factores de riesgo: placenta previa e historia de miomectomía o cesárea en embarazo previo. En caso de haber signos sugestivos de EAP por ecografía, las pacientes deben ser remitidas de manera inmediata, sin tener una edad gestacional mínima, a hospitales reconocidos como centros de referencia. Las modalidades virtuales de comunicación y atención en salud pueden facilitar la interacción entre las instituciones de atención primaria y los centros de referencia para EAP. Se debe evaluar el beneficio y riesgo de las modalidades de telemedicina. Recomendación 2. Es necesario que se definan hospitales de referencia para EAP en cada región de Colombia, asegurando el cubrimiento de la totalidad del territorio nacional. Es aconsejable concentrar el flujo de pacientes afectadas por esta condición en unos pocos hospitales, donde haya equipos de cirujanos con entrenamiento específico en EAP, disponibilidad de recursos especializados y un esfuerzo institucional por mejorar la calidad de atención, en busca de tener mejores resultados en la salud de las gestantes con esta condición. Para lograr ese objetivo los participantes recomiendan que los entes reguladores de la prestación de servicios de salud a nivel nacional, regional o local vigilen el proceso de remisión de estas pacientes, facilitando rutas administrativas en caso de que no exista contrato previo entre el asegurador y el hospital o la clínica seleccionada (IPS). Recomendación 3. En los centros de referencia para pacientes con EAP se invita a la creación de equipos que incorporen un grupo fijo de especialistas (obstetras, urólogos, cirujanos generales, radiólogos intervencionistas) encargados de atender todos los casos de EAP. Es recomendable que esos grupos interdisciplinarios utilicen el modelo de "paquete de intervención" como guía para la preparación de los centros de referencia para EAP. Este modelo consta de las siguientes actividades: preparación de los servicios, prevención e identificación de la enfermedad, respuesta ante la presentación de la enfermedad, aprendizaje luego de cada evento. La telemedicina facilita el tratamiento de EAP y debe ser tenida en cuenta por los grupos interdisciplinarios que atienden esta enfermedad. Recomendación 4. Los residentes de Obstetricia deben recibir instrucción en maniobras útiles para la prevención y el tratamiento del sangrado intraoperatorio masivo por placenta previa y EAP, tales como: la compresión manual de la aorta, el torniquete uterino, el empaquetamiento pélvico, el bypass retrovesical y la maniobra de Ward. Los conceptos básicos de diagnóstico y tratamiento de EAP deben incluirse en los programas de especialización en Ginecología y Obstetricia en Colombia. En los centros de referencia del EAP se deben ofrecer programas de entrenamiento a los profesionales interesados en mejorar sus competencias en EAP de manera presencial y virtual. Además, deben ofrecer soporte asistencial remoto (telemedicina) permanente a los demás hospitales en su región, en relación con pacientes con esa enfermedad. Recomendación 5. La finalización de la gestación en pacientes con sospecha de EAP y placenta previa, por imágenes diagnósticas, sin evidencia de sangrado vaginal activo, debe llevarse a cabo entre las semanas 34 y 36 6/7. El tratamiento quirúrgico debe incluir intervenciones secuenciales que pueden variar según las características de la lesión, la situación clínica de la paciente y los recursos disponibles. Las opciones quirúrgicas (histerectomía total y subtotal, manejo quirúrgico conservador en un paso y manejo expectante) deben incluirse en un protocolo conocido por todo el equipo interdisciplinario. En escenarios sin diagnóstico anteparto, es decir, ante un hallazgo intraoperatorio de EAP (evidencia de abultamiento violáceo o neovascularización de la cara anterior del útero), y con participación de personal no entrenado, se plantean tres situaciones: Primera opción: en ausencia de indicación de nacimiento inmediato o sangrado vaginal, se recomienda diferir la cesárea (cerrar la laparotomía antes de incidir el útero) hasta asegurar la disponibilidad de los recursos recomendados para llevar a cabo una cirugía segura. Segunda opción: ante indicación de nacimiento inmediato (por ejemplo, estado fetal no tranquilizador), pero sin sangrado vaginal o indicación de manejo inmediato de EAP, se sugiere realizar manejo en dos tiempos: se realiza la cesárea evitando incidir la placenta, seguida de histerorrafia y cierre de abdomen, hasta asegurar la disponibilidad de los recursos recomendados para llevar a cabo una cirugía segura. Tercera opción: en presencia de sangrado vaginal que hace imposible diferir el manejo definitivo de EAP, es necesario extraer el feto por el fondo del útero, realizar la histerorrafia y reevaluar. En ocasiones, el nacimiento del feto disminuye el flujo placentario y el sangrado vaginal se reduce o desaparece, lo que hace posible diferir el manejo definitivo de EAP. Si el sangrado significativo persiste, es necesario continuar con la histerectomía haciendo uso de los recursos disponibles: compresión manual de la aorta, llamado inmediato a los cirujanos con mejor entrenamiento disponible, soporte de grupos expertos de otros hospitales a través de telemedicina. Si una paciente con factores de riesgo para EAP (por ejemplo, miomectomía o cesárea previa) presenta retención de placenta posterior al parto vaginal, es recomendable confirmar la posibilidad de dicho diagnóstico (por ejemplo, realizando una ecografía) antes de intentar la extracción manual de la placenta. Conclusiones: esperamos que este primer consenso colombiano de EAP sirva como base para discusiones adicionales y trabajos colaborativos que mejoren los resultados clínicos de las mujeres afectadas por esta enfermedad. Evaluar la aplicabilidad y efectividad de las recomendaciones emitidas requerirá investigaciones adicionales.

ESOT Consensus Platform for Organ Transplantation: Setting the Stage for a Rigorous, Regularly Updated Development Process.

The European Society for Organ Transplantation (ESOT) has created a platform for the development of rigorous and regularly updated evidence based guidelines for clinical practice in the transplantation field. A dedicated Guideline Taskforce, including ESOT-council members, a representative from the Centre for Evidence in Transplantation, editors of the journal Transplant International has developed transparent procedures to guide the development of guidelines, recommendations, and consensus statements. During ESOT's first Consensus Conference in November 2022, leading experts will present in-depth evidence based reviews of nine themes and will propose recommendations aimed at reaching a consensus after public discussion and assessment by an independent jury. All recommendations and consensus statements produced for the nine selected topics will be published including the entire evidence-based consensus-finding process. An extensive literature review of each topic was conducted to provide final evidence and/or expert opinion.