Consensus Initiative Research Articles

A pan-European survey of robotic training for gastrointestinal surgery: European Robotic Surgery Consensus (ERSC) initiative.

There has been a recent rapid growth in the adoption of robotic systems across Europe. This study aimed to capture the current state of robotic training in gastrointestinal (GI) surgery and to identify potential challenges and barriers to training within Europe. A pan-European survey was designed to account for the opinion of the following GI surgery groups: (i) experts/independent practitioners; (ii) trainees with robotic access; (iii) trainees without robotic access; (iv) robotic industry representatives. The survey explored various aspects, including stakeholder opinions on bedside assisting, console operations, challenges faced and performance assessment. It was distributed through multiple European surgical societies and industry, in addition to social media and snowball sampling, between December 2023 and March 2024. A total of 1360 participants responded, with valid/complete responses from 1045 participants across 38 European countries. Six hundred and ninety-five (68.0%) experts and trainees were not aware of a dedicated robotic training curriculum for trainees, with 13/23 (56.5%) industry representatives not incorporating training for trainees in their programme. Among trainees with access to robotic systems, 94/195 (48.2%) had not performed any robotic cases, citing challenges including a lack of certified robotic trainers and training lists. Both experts and trainees agreed that trainees should start bedside assisting and operating on the console earlier than they currently do. Assessment tools of trainee performance were not being used by 139/479 (29.0%) participants. This pan-European survey highlights the need for a standardised robotic curriculum to address the gap in visceral training, assessment and certification. A greater emphasis may be required on implementing robotic training earlier through simulation training, dual console learning, bedside assisting, key clinical performance indicators, and assessment tools. The findings will guide the development of a pan-European consensus on the essential components of a comprehensive training programme for GI robotic surgery.

07 Partnering with patients with living and lived experience of eating disorders to improve inpatient care on an acute paediatric medicine unit

Abstract Background Since the COVID-19 pandemic, hospitals nationally are seeing a growing number of adolescent patients with eating disorders requiring acute medical stabilization, which is often a time of crisis in the trajectory of this ego-syntonic disorder. The complexity of these admissions often lead to safety events for patients and moral distress for clinicians. Medical admissions can also be an opportunity to engage youth and families. Patient partners are a pillar in healthcare quality improvement, but historically we have not engaged adolescent patient partners in improving acute eating disorder treatment. We gathered the experience of patients and families with living and lived experience of eating disorder treatment to improve their quality of care in an acute paediatric medicine unit. Objectives We aimed to describe the experience of patients and families with living and lived experience of eating disorder treatment, specifically acute medical stabilization, through a quality improvement patient engagement project. Design/Methods We used a mixed-methods design of semi-structured interviews and a focus group with adolescents with eating disorders and their caregivers in an acute medical unit at a tertiary paediatric hospital in British Columbia. We employed opportunity sampling by distributing recruitment flyers through patient experience councils, outpatient clinics, other non-acute units, and to all patients admitted with a medically unstable eating disorder at our hospital during the study period. The interviews consisted of open-ended questions, yes/no questions, and Likert scales related to four categories: admission process, inpatient experience, team communication, and discharge process. Two reviewers analyzed the qualitative data using thematic analysis, and the quantitative data was analyzed descriptively. Quality improvement projects are exempt from Research Ethics Board approval. However, we utilized the "A Project Ethics Community Consensus Initiative" (ARECCI) Ethics Guideline and Screening Tool and presented our proposal at the hospital's quality improvement and research oversight committees. Results We completed 8 interviews with patients with current living experience admitted to our acute medical unit. We also completed 1 interview with a patient with past lived experience and 1 focus group with patients and caregivers. Primary themes identified included uncertainty about their overall treatment journey and stress due to the sudden new expectations on the inpatient unit, such as activity restriction, meal plans by the hospital, and bathroom access after meal times. Patients identified the importance of relational care, inclusion in treatment planning, acknowledgement of the demanding nature of eating disorders, and individualized care. Due to variability in training, resource allocation, and gaps in communication, these patient-identified priorities are not always met. While 100% of participants stated they understood the reasons and goals for admission, participants averaged 3.7 on a 1 (lowest) to 5 (highest) Likert scale when asked to rate their satisfaction with the information they received. Five out of eight adolescents felt that there was consistency in communication within the team. Conclusion We demonstrate the complex needs of patients with eating disorders who require acute medical stabilization. Targeted knowledge mobilization initiatives through admission orientation documents and family-centered rounds could better meet those needs. We are currently developing an admission pamphlet and journal for patients admitted with a new eating disorder to our medical unit. Patient partners exhibited a high willingness to participate in our study and readily acknowledged the importance their contributions could hold for other patients.

An Update on the Six Recommendations from the 2012 IADMS Standard Measures Initiative: Assessing and Reporting Dancer Capacities, Risk Factors, and Injuries.

In 2012, the Standard Measures Consensus Initiative (SMCI) of the International Association for Dance Medicine and Science (IADMS) presented 6 recommendations regarding dance injury surveillance, definitions of injury and exposure, dance-specific screening, risk reduction strategies, and collaborative data management. The aim was to standardize risk factor measurement and injury reporting by researchers in dance medicine and science. Since then, numerous reports on the recording and reporting of injury data in sport and performing arts have been published. IADMS commissioned SMCI to update the 2012 recommendations, a process that involved 3 stages: (1) current field experts were invited to join SMCI, (2) SMCI members reviewed recent and relevant sport and performing arts literature, then drafted, discussed, and revised section updates, (3) IADMS invited individuals representing diverse backgrounds in the IADMS community to critically review drafted updates. The final update serves as a bridge from the 6 recommendations in the 2012 report to the current state of evidence. We continue to encourage use of dance injury surveillance systems and support that surveillance protocols be fit-for-purpose, and that failure to use clear and consistent injury definitions perpetuates a lack of rigor in dance injury research. Based on new evidence, we recommend that some aspects of injury surveillance be self-reported, that the choice of dance exposure measures be dependent on the research question, contextual factors, and type of injury/health problem(s) of interest, and that studies using dance-specific screening articulate specific objectives, validity, and reliability of each protocol. Future studies should focus on the development, implementation, and evaluation of strategies to minimize injury risk to improve consistency and rigor in data collection and research reporting on the health and wellness of dancer populations, thus facilitating a future dance injury consensus statement similar to recent statements published for sports and circus arts.

IMMEDIATE IMPLANT PLACEMENT AND LOADING IN THE MAXILLARY ESTHETIC ZONE DEMONSTRATE HIGH SURVIVAL RATES, BUT ESTHETIC AND FUNCTIONAL SUCCESS DATA IS STILL NEEDED

Hamilton A, Gonzaga L, Amorim K, Wittneben JG, Martig L, Morton D, Martin W, Gallucci GO, Wismeijer D. Selection criteria for immediate implant placement and immediate loading for single tooth replacement in the maxillary esthetic zone: A systematic review and meta-analysis. Clin Oral Implants Res. 2023 Sep;34 Suppl 26:304-348. doi:10.1111/clr.14109. Although it is not explicitly reported, it is understood that this study was supported by the International Team for Implantology (ITI) as part of their latest consensus initiative. Systematic review (with meta-analysis).

Recommendations for Post-Operative RadioTherapy After Complete Resection of Thymoma—a French DELPHI Consensus Initiative

IntroductionThymomas are rare intrathoracic malignancies that can relapse after surgery. Whether or not Post-Operative RadioTherapy (PORT) should be delivered after surgery remains a major issue. RADIORYTHMIC is an ongoing, multicenter, randomized phase 3 trial addressing this question in patients with completely R0 resected Masaoka-Koga stage IIb/III thymoma. Experts in the field met to develop recommendations for PORT. MethodsA scientific committee from the RYTHMIC network identified key issues regarding the modalities of PORT in completely resected thymoma. A DELPHI method was used to question 24 national experts, with 115 questions regarding the following: (1) imaging techniques, (2) clinical target volume (CTV) and margins, (3) dose constraints to organs at risk, (4) dose and fractionation, and (5) follow-up and records. Consensus was defined when opinions reached more than or equal to 80% agreement. ResultsWe established the following recommendations: preoperative contrast-enhanced computed tomography (CT) scan is recommended (94% agreement); optimization of radiation delivery includes either a four-dimensional CT-based planning (82% agreement), a breath-holding inspiration breath-hold–based planning, or daily control CT imaging (81% agreement); imaging fusion based on cardiovascular structures of preoperative and planning CT scan is recommended (82% agreement); right coronary and left anterior descending coronary arteries should be delineated as cardiac substructures (88% agreement); rotational RCMI/volumetric modulated arc therapy is recommended (88% agreement); total dose is 50 Gy (81% agreement) with 1.8 to 2 Gy per fraction (94% agreement); cardiac evaluation and follow-up for patients with history of cardiovascular disease are recommended (88% agreement) with electrocardiogram and evaluation of left ventricular ejection fraction at 5 years and 10 years. ConclusionThis is the first consensus for PORT in thymoma. Implementation will help to harmonize practices.

Addressing controversial areas in the management of advanced prostate cancer in Canada Areas of consensus and controversy from the third Canadian consensus forum.

The management of prostate cancer (PCa) is rapidly evolving. Treatment and diagnostic options grow annually, however, high-level evidence for the use of new therapeutics and diagnostics is lacking. In November 2022, the Genitourinary Research Consortium held its 3rd Canadian Consensus Forum (CCF3) to provide guidance on key controversial areas for management of PCa. A steering committee of eight multidisciplinary physicians identified topics for discussion and adapted questions from the Advanced Prostate Cancer Consensus Conference 2022 for CCF3. Questions focused on management of metastatic castration-sensitive prostate cancer (mCSPC); use of novel imaging, germline testing, and genomic profiling; and areas of non-consensus from CCF2. Fifty-eight questions were voted on during a live forum, with threshold for "consensus agreement" set at 75%. The voting panel consisted of 26 physicians: 13 urologists/uro-oncologists, nine medical oncologists, and four radiation oncologists. Consensus was reached for 32 of 58 questions (one ad-hoc). Consensus was seen in the use of local treatment, to not use metastasis-directed therapy for low-volume mCSPC, and to use triplet therapy for synchronous high-volume mCSPC (low prostate-specific antigen). Consensus was also reached on sufficiency of conventional imaging to manage disease, use of germline testing and genomic profiling for metastatic disease, and poly (ADP-ribose) polymerase (PARP) inhibitors for BRCA-positive prostate cancer. CCF3 identified consensus agreement and provides guidance on >30 practice scenarios related to management of PCa and nine areas of controversy, which represent opportunities for research and education to improve patient care. Consensus initiatives provide valuable guidance on areas of controversy as clinicians await high-level evidence.

Formy współpracy między państwami w celu odzyskania utraconych dóbr kultury – uwagi wokół poszukiwania optymalnego wzorca Forms of cooperation between

In the search for an optimal pattern of conduct for the settlement of disputes concerning the ownership of cultural property, the article characterises the legal means and conciliation initiatives available to states. The discussion is limited to the forms of cooperation confirmed in international law instruments, developed especially in the framework of UNESCO’s period of activity, as adopted in the second half of the 20th century and thereafter. In this context, the use of litigation before both the International Court of Justice and national courts is discussed. Attention is also given to conciliatory forms of dispute resolution, distinguishing between consensus initiatives involving only the states interested in resolving the dispute and forms extended to include the participation of impartial mediators supporting the parties in their search for a satisfactory solution. The article assumes that the development of an out-of-court compromise is particularly desirable when the settlement of a dispute concerning the ownership of a cultural asset by an international tribunal or national courts, due to the legal status in force, limits the prospect of obtaining a substantive settlement satisfactory to all parties involved in the conflict.

Delphi consensus on outcome measures for Alzheimer’s disease in clinical practice

AbstractBackgroundPrevious consensus initiatives on outcomes in Alzheimer’s disease (AD) have focused on clinical trials, may not be applicable to real‐world settings, and did not necessarily consider a comprehensive list or prioritize outcomes. The aim of this initiative was to achieve consensus among experts on priority outcomes and outcome measures for use in clinical practice when caring for patients with symptomatic AD.MethodThe Consensus Group consisted of 20 international voting members and a non‐voting Chair representing diverse specialities relevant to AD. A Delphi approach was used to generate shortlists of the most important outcomes and measures, and to develop consensus statements/recommendations (Figure 1). Initial lists of outcomes/measures were obtained from the ROADMAP project (roadmap‐alzheimer.org), and panel members were given the opportunity to suggest additional ones. The threshold for consensus was predefined as ≥70% voting “agree” or “strongly agree”. Shortlists of outcomes and measures were ranked by priority, their relative importance for mild and moderate disease was indicated, and assessment frequency was recommended. The modified GRADE criteria were used to rate the strength of recommendations and quality of evidence.ResultStrong consensus was readily reached on 37 statements/recommendations, grouped by ‘General Considerations’ (9) and nine domains (28) (Table 1), as well as on priority shortlists of outcomes and measures across the nine domains; an example of a priority shortlist for the domain ‘Cognitive abilities’ is shown in Table 2. The level of evidence for most items was low; therefore, most statements are based on panelists’ expert opinion. Key recommendations include: patient quality of life (QoL) outcome assessments should measure what the person performs well in addition to deficits, and take into account the values of patients and/or caregivers; there is a need for a more comprehensive measure to assess language and communication; ‘functional ability & dependency’ should include an assessment of motor function.ConclusionThis Delphi consensus highlights outcomes of highest importance in AD from a professional perspective and includes recommendations regarding the most appropriate measures for use in clinical practice. Further studies are needed to raise the strength of the recommendations and to explore patient/caregiver views.

The Artificial Intelligence in Teledermatology: A Narrative Review on Opportunities, Perspectives, and Bottlenecks.

Artificial intelligence (AI) is recently seeing significant advances in teledermatology (TD), also thanks to the developments that have taken place during the COVID-19 pandemic. In the last two years, there was an important development of studies that focused on opportunities, perspectives, and problems in this field. The topic is very important because the telemedicine and AI applied to dermatology have the opportunity to improve both the quality of healthcare for citizens and the workflow of healthcare professionals. This study conducted an overview on the opportunities, the perspectives, and the problems related to the integration of TD with AI. The methodology of this review, following a standardized checklist, was based on: (I) a search of PubMed and Scopus and (II) an eligibility assessment, using parameters with five levels of score. The outcome highlighted that applications of this integration have been identified in various skin pathologies and in quality control, both in eHealth and mHealth. Many of these applications are based on Apps used by citizens in mHealth for self-care with new opportunities but also open questions. A generalized enthusiasm has been registered regarding the opportunities and general perspectives on improving the quality of care, optimizing the healthcare processes, minimizing costs, reducing the stress in the healthcare facilities, and in making citizens, now at the center, more satisfied. However, critical issues have emerged related to: (a) the need to improve the process of diffusion of the Apps in the hands of citizens, with better design, validation, standardization, and cybersecurity; (b) the need for better attention paid to medico-legal and ethical issues; and (c) the need for the stabilization of international and national regulations. Targeted agreement initiatives, such as position statements, guidelines, and/or consensus initiatives, are needed to ensure a better result for all, along with the design of both specific plans and shared workflows.

Laterality indices consensus initiative (LICI): A Delphi expert survey report on recommendations to record, assess, and report asymmetry in human behavioural and brain research

ABSTRACT Laterality indices (LIs) quantify the left-right asymmetry of brain and behavioural variables and provide a measure that is statistically convenient and seemingly easy to interpret. Substantial variability in how structural and functional asymmetries are recorded, calculated, and reported, however, suggest little agreement on the conditions required for its valid assessment. The present study aimed for consensus on general aspects in this context of laterality research, and more specifically within a particular method or technique (i.e., dichotic listening, visual half-field technique, performance asymmetries, preference bias reports, electrophysiological recording, functional MRI, structural MRI, and functional transcranial Doppler sonography). Experts in laterality research were invited to participate in an online Delphi survey to evaluate consensus and stimulate discussion. In Round 0, 106 experts generated 453 statements on what they considered good practice in their field of expertise. Statements were organised into a 295-statement survey that the experts then were asked, in Round 1, to independently assess for importance and support, which further reduced the survey to 241 statements that were presented again to the experts in Round 2. Based on the Round 2 input, we present a set of critically reviewed key recommendations to record, assess, and report laterality research for various methods.

Abstract #1410803: Continuous Glucose Monitoring and Metrics for Clinical Trials - International Consensus

Randomized controlled trials and other prospective studies for novel interventions in people with diabetes have traditionally reported HbA1c (A1C) values, an estimate of the mean blood glucose for the previous 3 months. This is based on the Diabetes Control and Complications Trial’s established correlation between A1C and risk of microvascular complications. Change in A1C has been used by regulatory agencies for more than 30 years when evaluating diabetes medications’ efficacy. However, with the increasing development of continuous glucose monitoring (CGM), researchers have been increasingly interested in using CGM devices in prospective randomized clinical trials (RCT) to complement A1C and further assess the effects of therapeutic interventions. The diaTribe Foundation invited CGM experts with experience using CGM in clinical trials, FDA, NIH, ADA, and others to become part of this consensus initiative. People with diabetes were also invited. Participation was voluntary and not remunerated. Consolidated draft consensus recommendations and manuscript were developed. Draft materials were then the focus of a meeting in Barcelona, Spain just prior to the 15th ATTD on April 25, 2022. All members of the writing group attended the consensus conference either in person or virtually. The discussion and outcomes from the meeting were used to further refine and revise the consensus recommendations and subsequent manuscript. The final draft was then approved by all members of the writing group. International consensus recommendations include how to optimize CGM-derived glucose data collection in clinical studies: CGM device selection for RCT use, how to report time in range and other metrics, application of CGM sensors in RCT, classification of hypoglycemia or hyperglycemia in RCT, clinically meaningful differences, and CGM data inclusion in the final analysis set. The consensus statement provides recommendations on how to optimize CGM-derived glucose data collection in clinical studies, including CGM-derived glucose metrics that should be used by all researchers and regulatory agencies.

Antithrombotic treatment strategies in patients with established coronary atherosclerotic disease: 2022 joint clinical consensus statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), Association for Acute CardioVascular Care (ACVC) and European Association of Preventive Cardiology (EAPC).

Multiple guidelines and consensus papers have addressed the role of antithrombotic strategies in patients with established coronary artery disease (CAD). Since evidence and terminology continue to evolve, the European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Association for Acute Cardiovascular Care (ACVC) and European Association of Preventive Cardiology (EAPC) undertook a consensus initiative to guide clinicians to select the optimal antithrombotic regimen for each patient. The aim of this document is to provide an update for clinicians on best antithrombotic strategies in patients with established CAD, classifying each treatment option in relation to the number of antithrombotic drugs irrespective of whether the traditional mechanism of action is expected to mainly inhibit platelets or coagulation cascade. With the aim to reach comprehensiveness of available evidence, we systematically reviewed and performed meta-analyses by means of both direct and indirect comparisons to inform the present consensus document.

Adherence to therapy in people with rheumatic and musculoskeletal diseases in Italy and the role of the digital health: results of an expert Delphi consensus survey.

To present the results of a Delphi consensus survey among Italian rheumatologists on adherence to therapy in people with rheumatic and musculoskeletal diseases (RMDs) in Italy and the role of digital health. A taskforce of 12 rheumatologists comprehensively discussed the applicability of the 2020 EULAR Points to Consider (PtCs) for Italian rheumatology practice and formulated 44 new country-specific statements. Through an on-line survey, the panellists voted on their level of agreement with the statements using a 10-point Likert scale (0: no agreement; 10: total agreement). A combination of two distinct criteria, a mean agreement level ≥8 and a percentage of at least 75% of responses with a value ≥8, was deemed acceptable. The consensus threshold was reached for 43 of the 44 country-specific statements. The following were acknowledged among the barriers to applicability of the recommendations: visit time too short; lack of resources; lack of a clear operational flow-chart; lack of communication skills and poor knowledge of techniques to improve patient adherence by healthcare professionals (HCPs). This consensus initiative helps contribute to more widespread implementation of EULAR PtCs in Italian rheumatology practice. Optimisation of visit time, greater availability of resources, specific training, use of standardised and validated protocols, and active involvement of patients represent the main goals. Digital health can provide valuable support for the application of PtCs and, more generally, in improving adherence. A collaborative effort between HCPs, patients and their associations, scientific societies, and policymakers is strongly advocated to overcome some of the barriers.

Ethics in Quality Improvement Projects: Experiences of a Human Factors Team.

The Alberta Health Services Human Factors (HF) team completes many quality improvement projects involving human participants and requires a robust and efficient ethics process. The team has developed an ethics process utilizing ARECCI (A pRoject Ethics Community Consensus Initiative), wherein HF specialists review their project for alignment with a reference project. The reference project captures a broad range of work that the HF team may lead or support in some way, and it has a corresponding series of countermeasures that have been created to address ethical risks. While some challenges remain, the process has largely allowed the team to meet its ethics goals.

Support for consensus initiative

Support for consensus initiative

Application of the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The PRoLoG Consensus Initiative (Part 1-Clinical).

Our objective was to provide consensus recommendations from a consortium of academic and industry experts in the field of lymphoma and imaging for consistent application of the Lugano classification. Methods: Consensus was obtained through a series of meetings from July 2019 until September 2021 sponsored by the Pharma Imaging Network for Therapeutics and Diagnostics (PINTaD) as part of the PINTaD Response Criteria in Lymphoma Working Group (PRoLoG) consensus initiative. Results: Consensus recommendations clarified technical considerations for PET/CT and diagnostic CT from the Lugano classification, including updating the FDG avidity of different lymphoma entities, clarifying the response nomenclature, and refining lesion classification and scoring, especially with regard to scores 4 and 5 and the X category of the 5-point scale. Combination of metabolic and anatomic responses is clarified, as well as response assessment in cases of discordant or missing evaluations. Use of clinical data in the classification, especially the requirement for bone marrow assessment, is further updated on the basis of lymphoma entities. Clarification is provided with regard to spleen and liver measurements and evaluation, as well as nodal response. Conclusion: Consensus recommendations are made to comprehensively address areas of inconsistency and ambiguity in the classification encountered during response evaluation by end users, and such guidance should be used as a companion to the 2014 Lugano classification.

Application of the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The PRoLoG Consensus Initiative (Part 2-Technical).

The aim of this initiative was to provide consensus recommendations from a consortium of academic and industry experts in the field of lymphoma and imaging for the consistent application of imaging assessment with the Lugano classification. Methods: Consensus was obtained through a series of meetings from July 2019 to October 2021 sponsored by the PINTaD (Pharma Imaging Network for Therapeutics and Diagnostics) as part of the ProLoG (PINTaD RespOnse criteria in Lymphoma wOrking Group) consensus initiative. Results: Consensus recommendations encompass all technical imaging aspects of the Lugano classification. Some technical considerations for PET/CT and diagnostic CT are clarified with regards to required imaging series and scan visits, as well as acquisition and reconstruction of PET images and influence of lesion size and background activity. Recommendations are given on the role of imaging and clinical reviewers as well as on training and monitoring. Finally, an example template of an imaging case report form is provided to support efficient collection of data with Lugano Classification. Conclusion: Consensus recommendations are made to comprehensively address technical and imaging areas of inconsistency and ambiguity in the classification encountered by end users. Such guidance should be used to support standardized acquisition and evaluation with the Lugano 2014.

CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease

End points to determine the efficacy and safety of medical therapies for Crohn's disease (CD) and ulcerative colitis (UC) are evolving. Given the heterogeneity in current outcome measures, harmonizing end points in a core outcome set for randomized controlled trials is a priority for drug development in inflammatory bowel disease. Candidate outcome domains and outcome measures were generated from systematic literature reviews and patient engagement surveys and interviews. An iterative Delphi process was conducted to establish consensus: panelists anonymously voted on items using a 9-point Likert scale, and feedback was incorporated between rounds to refine statements. Consensus meetings were held to ratify the outcome domains and core outcome measures. Stakeholders were recruited internationally, and included gastroenterologists, colorectal surgeons, methodologists, and clinical trialists. A total of 235 patients and 53 experts participated. Patient-reported outcomes, quality of life, endoscopy, biomarkers, and safety were considered core domains; histopathology was an additional domain for UC. In CD, there was consensus to use the 2-item patient-reported outcome (ie, abdominal pain and stool frequency), Crohn's Disease Activity Index, Simple Endoscopic Score for Crohn's Disease, C-reactive protein, fecal calprotectin, and co-primary end points of symptomatic remission and endoscopic response. In UC, there was consensus to use the 9-point Mayo Clinic Score, fecal urgency, Robarts Histopathology Index or Geboes Score, fecal calprotectin, and a composite primary end point including both symptomatic and endoscopic remission. Safety outcomes should be reported using the Medical Dictionary for Regulatory Activities. This multidisciplinary collaboration involving patients and clinical experts has produced the first core outcome set that can be applied to randomized controlled trials of CD and UC.

An international survey mapping practice and barriers for upper-limb assessments in movement analysis

BackgroundUpper-limb movement analysis could improve our understanding of function, pathological mechanisms and inform rehabilitation and surgical decision-making. Despite the potential benefits, the use of clinical upper-limb motion analysis is not well established and it is not clear what the barriers to clinical motion analysis are. Research questionWhat is current practice for assessment of the upper-limb and what are the barriers currently limiting upper-limb motion analysis being routinely used in clinical practice? MethodsA web-based questionnaire was used to collect responses through international professional movement analysis society coordinators over an 18 month-period. ResultsA total of 55 responses were received and 75% of laboratories performed some form of upper-limb assessment. In total 44% of laboratories performed upper-limb assessments for clinical purposes and only 33% did 3D-movement analysis. The most commonly seen patient groups were those with neurological injury e.g. cerebral palsy (adults and children) and normal controls for comparative purposes. Barriers to upper-limb motion analysis were the availability of standard reference tasks, protocols, software, funding and clinical need. Practice was variable with no universally identified approaches to upper-limb movement analysis. Differences in practice were also identified between laboratories accredited by the Clinical Movement Analysis Society of the UK and Ireland and other international professional societies and affiliate laboratories. SignificanceThese findings may be used to inform the development of practice standards and progress the use of clinical motion analysis in the upper-limb. This study provides a summary and describes current practice, potentially providing access to peer support and experience for laboratories with an identified clinical need looking to conduct upper-limb assessment. A national picture (UK and Ireland) for practice regarding upper-limb assessment in this sub-population is presented. We have laid out further work which is needed to establish standards of practice or consensus initiatives for enhancing clinical upper-limb motion analysis.

Indication Criteria for Total Hip Arthroplasty in Patients with Hip Osteoarthritis-Recommendations from a German Consensus Initiative.

Background: Osteoarthritis of the hip (hip OA) is a leading cause of pain and disability in elderly people. If non-surgical therapies become ineffective, patients may consider total hip arthroplasty (THA). The biggest challenge in recommending a THA is identifying patients for whom the benefits of this procedure outweigh the potential risks. The aim of this initiative was to develop a clinical practice guideline with accompanying algorithm to guide consultations on THA, supported by a pocket-sized checklist. Methods: The initiative “Evidence- and consensus-based indication criteria for total hip replacement (EKIT-Hip)” used a stepwise approach, starting with an inauguration workshop, where a multidisciplinary German stakeholder panel from various scientific societies agreed on the working process. A Project Coordinating Group (PCG) was formed, and it performed a comprehensive systematic literature search of guidelines and systematic reviews related to the indication criteria for THA, as well as factors influencing outcomes. Based on best-available evidence, preliminary recommendations were formulated by the PCG and discussed with the stakeholder panel during a consensus meeting. In addition, the panel was asked to assess the feasibility of an extracted algorithm and to approve a final checklist. Results: In total, 31 recommendations were approved by 29 representatives of 23 societies. These were used to underpin an algorithm (EKIT-Algorithm), which indicates the minimum requirements for a THA (confirmed diagnosis of hip OA, present and documented individual burden of illness, ineffectiveness of non-surgical therapies, and absence of any contraindications). Once these criteria are fulfilled, further considerations should encompass the medical implications of modifiable risk factors and patients’ individual treatment goals, as discussed during shared decision making. The subsequently developed checklist (EKIT-Checklist) lists relevant criteria for decision making. Conclusions: Adherence to the EKIT-Algorithm, conveniently accessed via the EKIT-Checklist, should improve the standardization of decision making leading to a recommendation for THA. By applying minimum requirements and patient-related risk factors, as well as considering patients’ individual goals, it is possible to identify patients for whom the benefits of THA may exceed the potential risks.