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.

[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.

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.

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.

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.

[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.

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.

Pediatric lower respiratory tract infection: Considerations for the anesthesiologist.

Neonatal and childhood infectious diseases continue to be a global health problem. Acute respiratory tract infections are typically classified as upper respiratory tract infection and lower respiratory tract infections. The most common lower respiratory infections in childhood are pneumonia and bronchiolitis. Vaccination against measles, diphtheria, pertussis, Haemophilus influenzae, pneumococcus, and influenza resulted in a significant reduction in the incidence of acute respiratory tract infection globally. Though the global burden of the disease has decreased, the mortality rates still are higher in developing countries. Patients with severe lower respiratory tract infections and their complications are often evaluated for elective or emergency procedures. In this review article, the authors aim to discuss the etiology, pathogenesis, preoperative evaluation of lower respiratory tract infections, and the anesthesia implications pertinent to the practice of anesthesia.

Establishing a Core Outcome Set for Autosomal Dominant Polycystic Kidney Disease: Report of the Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Consensus Workshop.

The omission of outcomes that are of relevance to patients, clinicians, and regulators across trials in autosomal dominant polycystic kidney disease (ADPKD) limits shared decision making. The Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Initiative convened an international consensus workshop on October 25, 2018, to discuss the identification and implementation of a potential core outcome set for all ADPKD trials. This article summarizes the discussion from the workshops and the SONG-PKD core outcome set. Key stakeholders including 11 patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, and researchers) attended the workshop. Four themes emerged: "Relevance of trajectory and impact of kidney function" included concerns about a patient's prognosis and uncertainty of when they may need to commence kidney replacement therapy and the lack of an early prognostic marker to inform long-term decisions; "Discerning and defining pain specific to ADPKD" highlighted the challenges in determining the origin of pain, adapting to the chronicity and repeated episodes of pain, the need to place emphasis on pain management, and to have a validated measure for pain; "Highlighting ADPKD consequences" encompassed cyst-related complications and reflected patient's knowledge because of family history and the hereditary nature of ADPKD; and "Risk for life-threatening but rare consequences" such as cerebral aneurysm meant considering both frequency and severity of the outcome. Kidney function, mortality, cardiovascular disease, and pain were established as the core outcomes for ADPKD.

Performance of acute respiratory distress syndrome definitions in a high acuity paediatric intensive care unit.

BACKGROUND: For years, paediatric critical care practitioners used the adult American European Consensus Conference (AECC) and revised Berlin Definition (BD) for acute respiratory distress syndrome (ARDS) to study the epidemiology of paediatric ARDS (PARDS). In 2015, the paediatric specific definition, Paediatric Acute Lung Injury Consensus Conference (PALICC) was developed. The use of non-invasive metrics of oxygenation to stratify disease severity were introduced in this definition, although this potentially may lead to a confounding effect of disease severity since it is more common to place indwelling arterial lines in sicker patients. We tested the hypothesis that PALICC outperforms AECC/BD in our high acuity PICU, which employs a liberal use of indwelling arterial lines and high-frequency oscillatory ventilation (HFOV). METHODS: We retrospectively collected data from children < 18 years mechanically ventilated for at least 24 h in our tertiary care, university-affiliated paediatric intensive care unit. The primary endpoint was the difference in the number of PARDS cases between AECC/BD and PALICC. Secondary endpoints included mortality and ventilator free days. Performance was assessed by the area under the receiver operating characteristics curve (AUC-ROC). RESULTS: Data from 909 out of 2433 patients was eligible for analysis. AECC/BD identified 35 (1.4%) patients (mortality 25.7%), whereas PALICC identified 135 (5.5%) patients (mortality 14.1%). All but two patients meeting AECC/Berlin criteria were also identified by PALICC. Almost half of the cohort (45.2%) had mild, 33.3% moderate and 21.5% severe PALICC PARDS at onset. Highest mortality rates were seen in patients with AECC acute lung injury (ALI)/mild Berlin and severe PALICC PARDS. The AUC-ROC for Berlin was the highest 24 h (0.392 [0.124-0.659]) after onset. PALICC showed the highest AUC-ROC at the same moment however higher than Berlin (0.531 [0.345-0.716]). Mortality rates were significantly increased in patients with bilateral consolidations (9.3% unilateral vs 26.3% bilateral, p = 0.025). CONCLUSIONS: PALICC identified more new cases PARDS than the AECC/Berlin definition. However, both PALICC and Berlin performed poorly in terms of mortality risk stratification. The presence of bilateral consolidations was associated with a higher mortality rate. Our findings may be considered in future modifications of the PALICC criteria.

Mitochondrial neurogastrointestinal encephalomyopathy (MNGIE): Position paper on diagnosis, prognosis, and treatment by the MNGIE International Network.

Mitochondrial neurogastrointestinal encephalomyopathy (MNGIE) is a rare autosomal recessive disease caused by TYMP mutations and thymidine phosphorylase (TP) deficiency. Thymidine and deoxyuridine accumulate impairing the mitochondrial DNA maintenance and integrity. Clinically, patients show severe and progressive gastrointestinal and neurological manifestations. The onset typically occurs in the second decade of life and mean age at death is 37 years. Signs and symptoms of MNGIE are heterogeneous and confirmatory diagnostic tests are not routinely performed by most laboratories, accounting for common misdiagnosis. Factors predictive of progression and appropriate tests for monitoring are still undefined. Several treatment options showed promising results in restoring the biochemical imbalance of MNGIE. The lack of controlled studies with appropriate follow-up accounts for the limited evidence informing diagnostic and therapeutic choices. The International Consensus Conference (ICC) on MNGIE, held in Bologna, Italy, on 30 March to 31 March 2019, aimed at an evidence-based consensus on diagnosis, prognosis, and treatment of MNGIE among experts, patients, caregivers and other stakeholders involved in caring the condition. The conference was conducted according to the National Institute of Health Consensus Conference methodology. A consensus development panel formulated a set of statements and proposed a research agenda. Specifically, the ICC produced recommendations on: (a) diagnostic pathway; (b) prognosis and the main predictors of disease progression; (c) efficacy and safety of treatments; and (f) research priorities on diagnosis, prognosis, and treatment. The Bologna ICC on diagnosis, management and treatment of MNGIE provided evidence-based guidance for clinicians incorporating patients' values and preferences.

Leadership, management, quality, and innovation in organ donation: 2019 Kunming recommendations for One Belt & One Road countries.

The findings and recommendations of the 2019 consensus conference in organ donation, held in Kunming, China, are here reported. The main objective of the conference was to gather relevant information from experts involved in the field. The data and opinions provided allowed to propose a series of recommendations for "One Belt & One Road Countries" on how to achieve self-sufficiency in organ donation. Leadership in organ donation should be results-oriented and goal-driven based on the principles of excellence, empowerment, and engagement, providing the means, resources, and strategies necessary to reach the goal in earnest. Management includes good governance and transparency of a national registry of patients in the waiting list, donors, transplants, transplant teams, quality, and safety programs with continuous educational training of health care professionals. Mandatory monitoring, auditing and evaluation of quality must be incorporated into donation practices as relevant points in innovation, as well as the adoption of already established and novel processes and technologies. Achievement of self-sufficiency in organ donation is a crucial step to fight against transplant tourism and to prevent organ trafficking. Based on recommendations arising from the conference, each country could review and develop individualized action plans adjusted to its own circumstances and reality.

Evaluation of the standard procedure for treatment of periprosthetic joint infections of total knee and hip arthroplasty: a comparison of the 2015 and 2020 census in total joint replacement centres in Germany.

BACKGROUND: There are different procedures for both, the diagnosis and the therapy of a periprosthetic joint infection (PJI), however, national or international guidelines for a standardised treatment regime are still lacking. The present paper evaluates the use of the predominant treatment protocols for PJI in certified total joint replacement centres (EPZ) in Germany based on an EndoCert questionnaire. MATERIALS AND METHODS: The questionnaire was developed in cooperation with the EndoCert Certification Commission to survey the treatment protocols for septic revision arthroplasties in EPZ. Questions targeted the various treatment options including prosthesis preserving procedures (DAIR - Debridement, antibiotics, irrigation, and retention of the prosthesis), one-stage revision, two-stage revision, removal of the endoprosthesis and diagnostic sampling prior to re-implantation. All certified EPZ participated (n = 504) and the results from the current survey in 2020 were compared to data from a previous analysis in 2015. RESULTS: The number of centres that performed DAIR up to a maximum of 4 weeks and more than 10 weeks after index surgery decreased since 2015, while the number of centres that provided a one-stage revision as a treatment option increased (hip: + 6.3%; knee: + 6.6%). The majority of the centres (73.2%) indicated a 4-8 week period as the preferred interval between prosthesis removal and re-implantation in two-stage revision in hip as well as knee revisions. Centres with a higher number of revision surgeries (> 200 revisions/year), opted even more often for the 4-8 week period (92.3%). In two-stage revision the use of metal-based spacers with/without reinforcement with antibiotic-containing cement as an interim placeholder was significantly reduced in 2020 compared to 2015. There was also a clear preference for cemented anchoring in two-stage revision arthroplasty in the knee in 2020, whereas the majority of hip replacements was cementless. Additionally, in 2020 the number of samples for microbiological testing during the removal of the infected endoprosthesis increased and 72% of the centres took five or more samples. Overall, the number of EPZ with a standardised protocol for the procedure expanded from 2015 to 2020. CONCLUSION: While there was a trend towards standardised therapeutic algorithms for PJI with more uniform choices among the centres in 2020 compared to 2015, the treatment often remains an individual decision. However, since a consistent treatment regime is of vital importance with an expected rise of total numbers of revision arthroplasties, uniform definitions with regard to comparability and standardisation are necessary for the further development of the EndoCert system.

The future of medical scribes documenting in the electronic health record: results of an expert consensus conference.

BACKGROUND: With the use of electronic health records (EHRs) increasing and causing unintended negative consequences, the medical scribe profession has burgeoned, but it has yet to be regulated. The purpose of this study was to describe scribe workflow as well as identify the threats and opportunities for the future of the scribe industry. METHODS: The first phase of the study used ethnographic methods consisting of interviews and observations by a multi-disciplinary team of researchers at five United States sites. In April 2019, a two-day conference of experts representing different stakeholder perspectives was held to discuss the results from site visits and to predict the future of medical scribing. An interpretive content analysis approach was used to discover threats and opportunities for the future of medical scribes. RESULTS: Threats facing the medical scribe industry were related to changes in the documentation model, EHR usability, different payment structures, the need to acquire disparate data during clinical encounters, and workforce-related changes relevant to the scribing model. Simultaneously, opportunities for medical scribing in the future included extension of their role to include workflow analysis, acting as EHR-related subject-matter-experts, and becoming integrated more effectively into the clinical care delivery team. Experts thought that if EHR usability increases, the need for medical scribes might decrease. Additionally, the scribe role could be expanded to allow scribes to document more or take on more informatics-related tasks. The experts also anticipated an increased use of alternative models of scribing, like tele-scribing. CONCLUSION: Threats and opportunities for medical scribing were identified. Many experts thought that if the scribe role could be expanded to allow scribes to document more or take on more informatics activities, it would be beneficial. With COVID-19 continuing to change workflows, it is critical that medical scribes receive standardized training as tele-scribing continues to grow in popularity and new roles for scribes as medical team members are identified.

Prognostic significance of tumour budding assessed in gastric carcinoma according to the criteria of the International Tumour Budding Consensus Conference.

AIMS: In this study, we aimed to independently evaluate the utility and prognostic value of tumour budding (TB) according to the International Tumour Budding Consensus Conference (ITBCC) criteria in a large and a well-characterised European gastric cancer (GC) cohort. METHODS AND RESULTS: In 456 consecutive, surgically treated GCs, TB was assessed according to the ITBCC criteria and scored as Bd0 (no buds), Bd1 (one to four buds), Bd2 (five to nine buds) or Bd3 (≥10 buds). Cases with TB present were divided into low- (Bd1/Bd2) and high-budding (Bd3) groups. The TB score was analysed in relation to the clinicopathological parameters, overall survival (OS) and tumour-specific survival (TSS); 115 (25.2%) cases had no, 104 (22.8%) had low and 237 (52.0%) had high TB. The TB score correlated significantly with sex, Laurén phenotype, pT-, pN- and M categories, histological grade, R status; and lymph node ratio, lymphatic invasion, perineural invasion and HER2-, MET- and MSI status. In both total and intestinal-type early invasive GC (n = 57 and n = 41, respectively), significant associations between the presence and extent of TB and presence of lymph node metastasis were detected. Significant differences in OS and TSS between the TB groups were found; however, TB did not retain significance in multivariate models. CONCLUSIONS: Our data show that the ITBCC criteria can be applied to GC. The data correlated significantly with the diverse clinicopathological characteristics, including patient outcome, and can help to standardise diagnostics and research into special histological features of malignant tumours in general and GC in particular.

How to reduce anastomotic leakage in colorectal surgery-report from German expert meeting.

AIMS: Anastomotic leakage is one of the most worrisome complications in colorectal surgery. An expert meeting was organized to discuss and find a consensus on various aspects of the surgical management of colorectal disease with a possible impact on anastomotic leakage. METHODS: A three-step Delphi-method was used to find consensus recommendations. RESULTS: Strong consensus was achieved for the use of mechanical bowel preparation and oral antibiotics prior to colorectal resections, the abundance of non-selective NSAIDs, the preoperative treatment of severe iron deficiency anemia, and for attempting to improve the patients' general performance in the case of frailty. Concerning technical aspects of rectal resection, there was a strong consensus in regard to routinely mobilizing the splenic flexure, to dividing the inferior mesenteric vein, and to using air leak tests to check anastomotic integrity. There was also a strong consensus on not to oversew the stapled anastomoses routinely, to use protective ileostomies for low rectal and intersphincteric, but not for high-rectal anastomoses. Furthermore, a consensus was reached in regard to using CT-scans with rectal contrast enema to evaluate suspected anastomotic leakage as well as measuring C-reactive protein routinely to monitor the postoperative course after colorectal resections. No consensus was found concerning the indication and technique for testing bowel perfusion, the routine use of endoscopy to check the integrity of the anastomosis, the placement of transanal drains for rectal anastomoses and the management of anastomotic leakage with peritonitis. CONCLUSION: Consensus could be found for several practice details in the perioperative management in colorectal surgery that might have an influence on anastomotic leakage.

Intrathecal Therapy for Chronic Pain: A Review of Morphine and Ziconotide as Firstline Options.

OBJECTIVES: To evaluate the evidence for morphine and ziconotide as firstline intrathecal (IT) analgesia agents for patients with chronic pain. METHODS: Medline was searched (through July 2017) for "ziconotide" or "morphine" AND "intrathecal" AND "chronic pain," with results limited to studies in human populations. RESULTS: The literature supports the use of morphine (based primarily on noncontrolled, prospective, and retrospective studies) and ziconotide (based on randomized controlled trials and prospective observational studies) as first-choice IT therapies. The 2016 Polyanalgesic Consensus Conference (PACC) guidelines recommended both morphine and ziconotide as firstline IT monotherapy for localized and diffuse chronic pain of cancer-related and non-cancer-related etiologies; however, one consensus point emphasized ziconotide use, unless contraindicated, as firstline IT therapy in patients with chronic non-cancer-related pain. Initial IT therapy choice should take into consideration individual patient characteristics (e.g., pain location, response to previous therapies, comorbid medical conditions, psychiatric history). Trialing is recommended to assess medication efficacy and tolerability. For both morphine and ziconotide, the PACC guidelines recommend conservative initial dosing strategies. Due to its narrow therapeutic window, ziconotide requires careful dose titration. Ziconotide is contraindicated in patients with a history of psychosis. IT morphine administration may be associated with serious side effects (e.g., respiratory depression, catheter tip granuloma), require dose increases, and cause dependence over time. CONCLUSION: Based on the available evidence, morphine and ziconotide are recommended as firstline IT monotherapy for cancer-related and non-cancer-related pain. The choice of first-in-pump therapy should take into consideration patient characteristics and the advantages and disadvantages of each medication.