Development Of Consensus Statement Research Articles

Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Italian S3-Guideline on the treatment of Atopic Eczema - Part 1: Systemic therapy, adapted from EuroGuiDerm by the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Environmental Dermatology (SIDAPA).

SIDeMaST (Società Italiana di Dermatologia Medica, Chirurgica, Estetica e delle Malattie Sessualmente Trasmesse) contributed to the development of the present guideline on the systemic treatment of chronic plaque psoriasis. With the permission of EuroGuiDerm, SIDeMaST adapted the guideline to the Italian healthcare context to supply a reliable and affordable tool to Italian physicians who take care of patients affected by atopic dermatitis. The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This first part of the guideline includes general information on its scope and purpose, the health questions covered, target users and a methods section. It also provides guidance on which patients should be treated with systemic therapies, as well as recommendations and detailed information on each systemic drug. The systemic treatment options discussed in the guideline comprise conventional immunosuppressive drugs (azathioprine, ciclosporin, glucocorticosteroids, methotrexate and mycophenolate mofetil), biologics (dupilumab, lebrikizumab, nemolizumab, omalizumab and tralokinumab) and janus kinase inhibitors (abrocitinib, baricitinib and upadacitinib). Part two of the guideline will address avoidance of provocation factors, dietary interventions, immunotherapy, complementary medicine, educational interventions, occupational and psychodermatological aspects, patient perspective and considerations for pediatric, adolescent, pregnant and breastfeeding patients.

Italian S3-Guideline on the treatment of Atopic Eczema - First Update, adapted from EuroGuiDerm by the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Occupational Dermatology (SIDAPA).

The evidence- and consensus-based guideline on atopic eczema, published in JEADV on 18 August 2022 (part 1) and 3 September 2022 (part 2) was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. To reflect the most recent evidence on novel systemic medications, an update was published in October 2022. According to the purpose of the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Environmental Dermatology (SIDAPA) to adapt the EuroGuiDerm guideline on the treatment of atopic eczema into the Italian Healthcare setting, the original update has been supplemented by inserting notes, well highlighted by the original text, to emphasize the laws, rules, procedures and suggestions of the Italian Ministry of Health and regional Health authorities.

Italian S3-Guideline on the treatment of Atopic Eczema - Part 2: non-systemic treatments and treatment recommendations for special AE patient populations, adapted from EuroGuiDerm by the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Occupational Dermatology (SIDAPA).

SIDeMaST (Società Italiana di Dermatologia Medica, Chirurgica, Estetica e delle Malattie Sessualmente Trasmesse) contributed to the development of the present guideline on the systemic treatment of chronic plaque psoriasis. With the permission of EuroGuiDerm, SIDeMaST adapted the guideline to the Italian healthcare context to supply a reliable and affordable tool to Italian physicians who take care of patients affected by atopic dermatitis. The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This second part of the guideline includes recommendations and detailed information on basic therapy with emollients and moisturizers, topical anti-inflammatory treatment, antimicrobial and antipruritic treatment and UV phototherapy. Furthermore, this part of the guideline covers techniques for avoiding provocation factors, as well as dietary interventions, immunotherapy, complementary medicine and educational interventions for patients with atopic eczema and deals with occupational and psychodermatological aspects of the disease. It also contains guidance on treatment for pediatric and adolescent patients and pregnant or breastfeeding women, as well as considerations for patients who want to have a child. A chapter on the patient perspective is also provided. The first part of the guideline, published separately, contains recommendations and guidance on systemic treatment with conventional immunosuppressive drugs, biologics and janus kinase (JAK) inhibitors, as well as information on the scope and purpose of the guideline, and a section on guideline methodology.

Consensus statements on endoscopic ultrasound-guided tissue acquisition. Guidelines from the Asian Endoscopic Ultrasound Group.

This consensus was developed by the Asian EUS Group (AEG), who aimed to formulate a set of practice guidelines addressing various aspects of endoscopic ultrasound-guided tissue acquisition (EUS-TA). The AEG initiated the development of consensus statements and formed an expert panel comprising surgeons, gastroenterologists, and pathologists. Three online consensus meetings were conducted to consolidate the statements and votes. The statements were presented and discussed in the first two consensus meetings and revised according to comments. Final voting was conducted at a third consensus meeting. The Grading of Recommendations, Assessment, Development, and Evaluation system was adopted to define the strength of the recommendations and quality of evidence. A total of 20 clinical questions and statements regarding EUS-TA were formulated. The committee recommended that fine-needle biopsy (FNB) needles be preferred over conventional fine-needle aspiration (FNA) needles for EUS-TA of subepithelial lesions. For solid pancreatic masses, rapid on-site evaluation is not routinely recommended when FNB needles are used. For dedicated FNB needles, fork-tip and Franseen-tip needles have essentially equivalent performance. This consensus provides guidance for EUS-TA, thereby enhancing the quality of EUS-TA.

P350 Development of consensus statements for transitional care for adolescents with Inflammatory bowel disease throughout Australia and New Zealand

Abstract Background The incidence of paediatric inflammatory bowel disease (IBD) is rising, and as such there is an increasing need to support adolescents with IBD as they from transition from paediatric to adult care. The use of a structured process for transition is well supported in the literature, however, variation in the delivery of transitional care for adolescents with IBD has been identified across Australis and New Zealand. The aim of this study was to develop consensus statements, based on evidence and expert opinion, to guide transitional care services in IBD. Methods The consensus statements were developed using a modified UCLA-RAND methodology. An IBD expert steering committee was formed, and then a systematic literature review conducted to grade the available evidence and inform initial development of consensus statements. A multi-disciplinary group was formed comprising 16 participants [clinicians, nurses, surgeons, psychologists], that voted anonymously on the level of appropriateness and necessity for each consensus statement, as well as provided general feedback for each. Scoring was facilitated using Likert scales [1=lowest, 9=highest] with a median ≥7 required for inclusion. Results Fourteen consensus statements were devised by the Steering committee (Table 1). Key recommendations including the use of a structured transition programme and transition coordinator. Statements recommended assessment of mental health and transition readiness, and outlined discussion points regarding lifestyle, environment and psychosocial factors to be held with adolescents. The importance of allied health input, the age for transition, recommendations for clinical communication and handover were highlighted, as well as considerations for individual patients. In the first voting round by the multi-disciplinary group each statement reached a median score of ≥ 8 for appropriateness, and ≥7 for necessity. An online meeting with both groups was held to discuss voting results and refine statements. Table 1. Final consensus statements to guide transition of children with inflammatory bowel disease in Australasia. Conclusion There is an identified need for guidance in paediatric to adult transitional care for adolescents with IBD. Consensus statements were developed by a multi-disciplinary group, supported by published evidence, to provide this guidance. The planned publication of the consensus process and statements will facilitate standardize delivery of IBD transitional care within Australasia.

A modified Delphi consensus statement on patellar instability: part II.

The aim of this study was to establish consensus statements on medial patellofemoral ligament (MPFL) reconstruction, anteromedialization tibial tubercle osteotomy, trochleoplasty, and rehabilitation and return to sporting activity in patients with patellar instability, using the modified Delphi process. This was the second part of a study dealing with these aspects of management in these patients. As in part I, a total of 60 surgeons from 11 countries contributed to the development of consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered unanimous. Of 41 questions and statements on patellar instability, none achieved unanimous consensus, 19 achieved strong consensus, 15 achieved consensus, and seven did not achieve consensus. Most statements reached some degree of consensus, without any achieving unanimous consensus. There was no consensus on the use of anchors in MPFL reconstruction, and the order of fixation of the graft (patella first versus femur first). There was also no consensus on the indications for trochleoplasty or its effect on the viability of the cartilage after elevation of the osteochondral flap. There was also no consensus on postoperative immobilization or weightbearing, or whether paediatric patients should avoid an early return to sport.

Consensus recommendations in the management of Ewing sarcoma from the National Ewing Sarcoma Tumor Board.

Ewing sarcoma (ES) is a malignant tumor of bone and soft tissue that most often occurs in adolescents and young adults. Despite an international coordinated approach, several nuances, discrepancies, and debates remain in defining the standard of care for treating ES. In this review, the authors leverage the expertise assembled by formation of the National Ewing Sarcoma Tumor Board, a multi-institution, multidisciplinary virtual tumor board that meets monthly to discuss complicated and challenging cases of ES. This report is focused on select topics that apply to the management of patients with newly diagnosed ES. The specific topics covered include indications for bone marrow aspirate and biopsy for initial evaluation compared with fluorodeoxyglucose-positron emission tomography, the role of interval compressed chemotherapy in patients aged 18years and older, the role of adding ifosfamide/etoposide to vincristine/doxorubicin/cyclophosphamide for patients with metastatic disease, the data on and role of high-dose chemotherapy with autologous stem cell transplantation, maintenance therapy, and whole-lung irradiation. The data referenced are often limited to subgroup analyses and/or compiled from multiple sources. Although not intended to replace the clinical judgement of treating physicians, the guidelines are intended to provide clarity and recommendations for the upfront management of patients with ES. PLAIN LANGUAGE SUMMARY: Ewing sarcoma is a malignant tumor of bone and soft tissue that most often occurs in adolescents and young adults. For this review, the authors used the experience of the National Ewing Sarcoma Tumor Board, a multi-institution, multidisciplinary virtual tumor board that meets monthly to discuss complicated and challenging cases of Ewing sarcoma. Although not intended to replace the clinical judgement of treating physicians, the guidelines will focus on the development of consensus statements for the upfront management of patients with Ewing sarcoma.

Men of color in the health professions: Proceedings from the 2022 ADEA Men of Color in the Health Professions Summit.

The purpose of the American Dental Education Association (ADEA) Men of Color in the Health Professions Summit, held in August 2022 at ADEA's headquarters in Washington, DC, was to gather key thought leaders across a myriad of health professions and healthcare organizations and schools to cultivate intentional cross-disciplinary efforts in championing the need to address the low number of men of color entering not only dental, but also medicine, pharmacy, and health-related research careers. A pivotal follow-up step from the inaugural ADEA President's Symposium on Men of Color in the Health Professions at the March 2022 ADEA Annual Session & Exhibition in Philadelphia, the summit brought together academic health professions leaders, government agencies, health professions associations, and other key stakeholders to develop an action plan to support men of color entering the health professions. Moving the needle forward and increasing opportunities for underrepresented men of color in the health professions requires all academic health professions to work together. Highlights of the Summit included a keynote presentation by David Satcher, MD, PhD, the 16th Surgeon General of the United States; workgroup consensus statement development; health career pathways program presentations; strategic forecasting regarding challenges and opportunities in developing a coalition of health professions organizations to support men of color in the health professions; and frameworks for exploring coalition building.

The evolving use of biomarkers in heart transplantation: Consensus of an expert panel

In heart transplantation, the use of biomarkers to detect the risk of rejection has been evolving. In this setting, it is becoming less clear as to what is the most reliable test or combination of tests to detect rejection and assess the state of the alloimmune response. Therefore, a virtual expert panel was organized in heart and kidney transplantation to evaluate emerging diagnostics and how they may be best utilized to monitor and manage transplant patients. This manuscript covers the heart content of the conference and is a work product of the American Society of Transplantation’s Thoracic and Critical Care Community of Practice. This paper reviews currently available and emerging diagnostic assays and defines the unmet needs for biomarkers in heart transplantation. Highlights of the in-depth discussions among conference participants that led to development of consensus statements are included. This conference should serve as a platform to further build consensus within the heart transplant community regarding the optimal framework to implement biomarkers into management protocols and to improve biomarker development, validation and clinical utility. Ultimately, these biomarkers and novel diagnostics should improve outcomes and optimize quality of life for our transplant patients.

European guideline (EuroGuiDerm) on atopic eczema - part II: non-systemic treatments and treatment recommendations for special AE patient populations.

The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This second part of the guideline includes recommendations and detailed information on basic therapy with emollients and moisturizers, topical anti-inflammatory treatment, antimicrobial and antipruritic treatment and UV phototherapy. Furthermore, this part of the guideline covers techniques for avoiding provocation factors, as well as dietary interventions, immunotherapy, complementary medicine and educational interventions for patients with atopic eczema and deals with occupational and psychodermatological aspects of the disease. It also contains guidance on treatment for paediatric and adolescent patients and pregnant or breastfeeding women, as well as considerations for patients who want to have a child. A chapter on the patient perspective is also provided. The first part of the guideline, published separately, contains recommendations and guidance on systemic treatment with conventional immunosuppressive drugs, biologics and janus kinase (JAK) inhibitors, as well as information on the scope and purpose of the guideline, and a section on guideline methodology.

European guideline (EuroGuiDerm) on atopic eczema: part I - systemic therapy.

The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This first part of the guideline includes general information on its scope and purpose, the health questions covered, target users and a methods section. It also provides guidance on which patients should be treated with systemic therapies, as well as recommendations and detailed information on each systemic drug. The systemic treatment options discussed in the guideline comprise conventional immunosuppressive drugs (azathioprine, ciclosporin, glucocorticosteroids, methotrexate and mycophenolate mofetil), biologics (dupilumab, lebrikizumab, nemolizumab, omalizumab and tralokinumab) and janus kinase inhibitors (abrocitinib, baricitinib and upadacitinib). Part two of the guideline will address avoidance of provocation factors, dietary interventions, immunotherapy, complementary medicine, educational interventions, occupational and psychodermatological aspects, patient perspective and considerations for paediatric, adolescent, pregnant and breastfeeding patients.

WHO-led consensus statement on vaccine delivery costing: process, methods, and findings

BackgroundDifferences in definitions and methodological approaches have hindered comparison and synthesis of economic evaluation results across multiple health domains, including immunization. At the request of the World Health Organization’s (WHO) Immunization and Vaccines-related Implementation Research Advisory Committee (IVIR-AC), WHO convened an ad hoc Vaccine Delivery Costing Working Group, comprising experts from eight organizations working in immunization costing, to address a lack of standardization and gaps in definitions and methodological guidance. The aim of the Working Group was to develop a consensus statement harmonizing terminology and principles and to formulate recommendations for vaccine delivery costing for decision making. This paper discusses the process, findings of the review, and recommendations in the Consensus Statement.MethodsThe Working Group conducted several interviews, teleconferences, and one in-person meeting to identify groups working in vaccine delivery costing as well as existing guidance documents and costing tools, focusing on those for low- and middle-income country settings. They then reviewed the costing aims, perspectives, terms, methods, and principles in these documents. Consensus statement principles were drafted to align with the Global Health Cost Consortium costing guide as an agreed normative reference, and consensus definitions were drafted to reflect the predominant view across the documents reviewed.ResultsThe Working Group identified four major workstreams on vaccine delivery costing as well as nine guidance documents and eleven costing tools for immunization costing. They found that some terms and principles were commonly defined while others were specific to individual workstreams. Based on these findings and extensive consultation, recommendations to harmonize differences in terminology and principles were made.ConclusionsUse of standardized principles and definitions outlined in the Consensus Statement within the immunization delivery costing community of practice can facilitate interpretation of economic evidence by global, regional, and national decision makers. Improving methodological alignment and clarity in program costing of health services such as immunization is important to support evidence-based policies and optimal resource allocation. On the other hand, this review and Consensus Statement development process revealed the limitations of our ability to harmonize given that study designs will vary depending upon the policy question that is being addressed and the country context.

EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 2: specific clinical and comorbid situations.

This evidence- and consensus-based guideline on the treatment of psoriasis vulgaris was developed following the EuroGuiDerm Guideline and Consensus Statement Development Manual. The second part of the guideline provides guidance for specific clinical and comorbid situations such as treating psoriasis vulgaris patient with concomitant psoriatic arthritis, concomitant inflammatory bowel disease, a history of malignancies or a history of depression or suicidal ideation. It further holds recommendations for concomitant diabetes, viral hepatitis, disease affecting the heart or the kidneys as well as concomitant neurological disease. Advice on how to screen for tuberculosis and recommendations on how to manage patients with a positive tuberculosis test result are given. It further covers treatment for pregnant women or patients with a wish for a child in the near future. Information on vaccination, immunogenicity and systemic treatment during the COVID-19 pandemic is also provided.

EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 1: treatment and monitoring recommendations.

This evidence- and consensus-based guideline on the treatment of psoriasis vulgaris was developed following the EuroGuiDerm Guideline and Consensus Statement Development Manual. The first part of the guideline includes general information on the scope and purpose, health questions covered, target users and strength/limitations of the guideline. Suggestions for disease severity grading and treatment goals are provided. It presents the general treatment recommendations as well as detailed management and monitoring recommendations for the individual drugs. The treatment options discussed in this guideline are as follows: acitretin, ciclosporin, fumarates, methotrexate, adalimumab, apremilast, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab.

Lessons learnt transitioning to a digital conference during the COVID-19 pandemic

The King’s John Price Paediatric Respiratory Conference1 is one of the largest annual gatherings of paediatric respiratory professionals in Europe, attracting over 550 participants. The COVID-19 pandemic forced the conference...

Definition determines weight regain outcomes after sleeve gastrectomy

BackgroundSleeve gastrectomy (SG) is one of the most commonly undertaken bariatric procedures. Weight regain after bariatric surgery, when significant, may be associated with recurrence of diabetes and deterioration in quality of life. Furthermore, it may be more common after SG than bypass procedures. Yet the understanding of the significance of weight regain is hampered by poor reporting and no consensus statements or guidelines. ObjectivesTo illustrate how the lack of a standard definition significantly alters reported SG outcomes and to contribute to the discussion of how weight regain should be defined. SettingCounties Manukau Health, a public teaching hospital that performs over 150 bariatric procedures per year. MethodsA retrospective cohort of SG patients followed up at 5 years was used to illustrate how the presence of multiple definitions in the literature significantly affects outcome reporting for weight regain. Post hoc analyses were used to explore the relationship between weight change and clinical outcomes. ResultsApplying 6 definitions of weight regain to a retrospective cohort of SG patients resulted in 6 different rates ranging from 9%–91%. Post hoc analyses revealed significant associations between weight change and the Bariatric Analysis Reporting Outcome System (BAROS) score as well as patient opinion. ConclusionThe nonuniform reporting of weight regain appears to significantly affect SG outcome reporting. Development of consensus statements and guidelines would ameliorate this problem. Ideally, research groups with access to large robust databases would aid in the development of any proposed weight regain definitions. In the interim, bariatric literature would benefit by all published series clearly reporting how weight regain is defined in the study population.

Clinical Consensus Statement Development Manual.

Clinical consensus statements reflect opinions drafted by content experts for which consensus is sought using explicit methodology to identify areas of agreement and disagreement. In contrast to clinical practice guidelines, which are based primarily on high-level evidence, clinical consensus statements are more applicable to situations where evidence is limited or lacking, yet there are still opportunities to reduce uncertainty and improve quality of care. This manual describes methodology used by the American Academy of Otolaryngology-Head and Neck Surgery Foundation to promote rapid and consistent development of clinical consensus statements for its membership. Although the manual contains specific practices relevant to the Academy, the principles are also explained and may help other organizations create similar products.

Communicating Potential Radiation-Induced Cancer Risks From Medical Imaging Directly to Patients.

Over the past decade, efforts have increasingly been made to decrease radiation dose from medical imaging. However, there remain varied opinions about whether, for whom, by whom, and how these potential risks should be discussed with patients. We aimed to provide a review of the literature regarding awareness and communication of potential radiation-induced cancer risks from medical imaging procedures in hopes of providing guidance for communicating these potential risks with patients. We performed a systematic literature review on the topics of radiation dose and radiation-induced cancer risk awareness, informed consent regarding radiation dose, and communication of radiation-induced cancer risks with patients undergoing medical imaging. We included original research articles from North America and Europe published between 1995 and 2014. From more than 1200 identified references, a total of 22 original research articles met our inclusion criteria. Overall, we found that there is insufficient knowledge regarding radiation-induced cancer risks and the magnitude of radiation dose associated with CT examinations among patients and physicians. Moreover, there is minimal sharing of information before nonacute imaging studies between patients and physicians about potential long-term radiation risks. Despite growing concerns regarding medical radiation exposure, there is still limited awareness of radiation-induced cancer risks among patients and physicians. There is also no consensus regarding who should provide patients with relevant information, as well as in what specific situations and exactly what information should be communicated. Radiologists should prioritize development of consensus statements and novel educational initiatives with regard to radiation-induced cancer risk awareness and communication.

Spontaneous cecum perforation associated with entero-behçet

2. Kobayashi K, Ueno F, Bito S, et al. Development of consensus statements for the diagnosis and management of intestinal Behcet’s disease using a modified delphi approach. J Gastroenterol 2007;42:737-45