Consensus Process Research Articles

Therapeutic Pathways in Sarcoidosis. A Position Paper of the German Society of Respiratory Medicine (DGP)

The present recommendations on the therapy of sarcoidosis of the German Respiratory Society (DGP) was written in 2023 as a German-language supplement and update of the international guidelines of the European Respiratory Society (ERS) from 2021. It contains 5 PICO questions (Patients, Intervention, Comparison, Outcomes) agreed in the consensus process, which are explained in the background text of the four articles: Confirmation of diagnosis and monitoring of the disease under therapy, general therapy recommendations, therapy of cutaneous sarcoidosis, therapy of cardiac sarcoidosis.

A core outcome set for acute necrotizing pancreatitis: An Eastern Association for the Surgery of Trauma modified Delphi method consensus study.

The management of acute necrotizing pancreatitis (ANP) has changed dramatically over the past 20 years including the use of less invasive techniques, the timing of interventions, nutritional management, and antimicrobial management. This study sought to create a core outcome set (COS) to help shape future research by establishing a minimal set of essential outcomes that will facilitate future comparisons and pooling of data while minimizing reporting bias. A modified Delphi process was performed through involvement of ANP content experts. Each expert proposed a list of outcomes for consideration, and the panel anonymously scored the outcomes on a 9-point Likert scale. Core outcome consensus defined a priori as >70% of scores receiving 7 to 9 points and <15% of scores receiving 1 to 3 points. Feedback and aggregate data were shared between rounds with interclass correlation trends used to determine the end of the study. A total of 19 experts agreed to participate in the study with 16 (84%) participating through study completion. Forty-three outcomes were initially considered with 16 reaching consensuses after four rounds of the modified Delphi process. The final COS included outcomes related to mortality, organ failure, complications, interventions/management, and social factors. Through an iterative consensus process, content experts agreed on a COS for the management of ANP. This will help shape future research to generate data suitable for pooling and other statistical analyses that may guide clinical practice. Therapeutic/Care Management; Level V.

Delphi consensus on the transition from paediatric to adult epilepsy care

IntroductionThe transition from paediatric to adult neurology consultations in patients with epilepsy must be understood as a process in which the patient acquires independence in the management of their disease and faces new issues related to adulthood. The aim of this study is to gather the opinion of experts in epilepsy on this transition in order to issue recommendations. MethodsUsing a Delphi consensus process, 54 paediatric and adult neurologists with expertise in epilepsy expressed their degree of agreement on 38 statements on about the transition from paediatric to adult consultations, grouped into the following sections: (1) preparation and moments prior to transition; (2) transition process; and (3) moments after the transition and follow-up. ResultsAfter 2 rounds, consensus was reached for 33 statements (86.8%). For the remaining 5 statements (13.2%), there was neither agreement nor disagreement. Among the subjects for which consensus was strongest was the involvement of the patient and family, who must be provided sufficient information to resolve their doubts and concerns. Before referral, the clinical report must be reviewed to ensure that it contains all relevant information on the disease. During the first follow-up visits after the transition, the patient's knowledge should be brought up to date in order to promote their autonomy. ConclusionThe clinical report, early preparation, and complete case review are considered fundamental in the process of transition from paediatric to adult neurology care.

European Society for Surgery of the Shoulder and Elbow (SECEC) rotator cuff tear registry Delphi consensus

The purpose of this study was to establish consensus statements via a Delphi process on the factors that should be included in a registry for those patients undergoing rotator cuff tear treatment. A consensus process on the treatment of rotator cuff utilizing a modified Delphi technique was conducted. Fifty-seven surgeons completed these consensus statements and 9 surgeons declined. The participants were members of the European Society for Surgery of the Shoulder and Elbow committees representing 23 European countries. Thirteen questions were generated regarding the diagnosis and follow-up of rotator cuff tears were distributed, with 3 rounds of questionnaires and final voting occurring. Consensus was defined as achieving 80%-89% agreement, whereas strong consensus was defined as 90%-99% agreement, and unanimous consensus was defined by 100% agreement with a proposed statement. Of the 13 total questions and consensus statements on rotator cuff tears, 1 achieved unanimous consensus, 6 achieved strong consensus, 5 achieved consensus, and 1 did not achieve consensus. The statement that reached unanimous consensus was that the factors in the patient history that should be evaluated and recorded in the setting of suspected/known rotator cuff tear are age, gender, comorbidities, smoking, traumatic etiology, prior treatment including physical therapy/injections, pain, sleep disturbance, sports, occupation, workmen's compensation, hand dominance, and functional limitations. The statement that did not achieve consensus was related to the role of ultrasound in the initial diagnosis of patients with rotator cuff tears. Nearly all questions reached consensus among 57 European Society for Surgery of the Shoulder and Elbow members representing 23 different European countries. We encourage surgeons to use this minimum set of variables to establish rotator cuff registries and multicenter studies. By adapting and using compatible variables, data can more easily be compared and eventually merged across countries.

Lifestyle Medicine Performance Measures: An Expert Consensus Statement Defining Metrics to Identify Remission or Long-Term Progress Following Lifestyle Medicine Treatment.

The objective of this expert consensus process was to define performance measures that can be used to document remission or long-term progress following lifestyle medicine (LM) treatment. Expert panel members with experience in intensive, therapeutic lifestyle change (ITLC) developed a list of performance measures for key disease states, using an established process for developing consensus statements adapted for the topic. Proposed performance measures were assessed for consensus using a modified Delphi process. After a series of meetings and an iterative Delphi process of voting and revision, a final set of 32 performance measures achieved consensus. These were grouped in 10 domains of diseases, conditions, or risk factors, including (1) Cardiac function, (2) Cardiac risk factors, (3) Cardiac medications and procedures, (4) Patient-centered cardiac health, (5) Hypertension, (6) Type 2 diabetes and prediabetes, (7) Metabolic syndrome, (8) Inflammatory conditions, (9) Inflammatory condition patient-centered measures, and (10) Chronic kidney disease. These measures compose a set of performance standards that can be used to evaluate the effectiveness of LM treatment for these conditions.

Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance

BackgroundSome high-grade cervical lesions and cervical cancers (HSIL+) test negative for human papillomavirus (HPV). The HPV-negative fraction varies between 0.03 % and 15 % between different laboratories. Monitoring and extended re-analysis of HPV-negative HSIL+ could thus be helpful to monitor performance of HPV testing services. We aimed to a) provide a real-life example of a quality assurance (QA) program based on re-analysis of HPV-negative HSIL+ and b) develop international guidance for QA of HPV testing services based on standardized identification of apparently HPV-negative HSIL+ and extended re-analysis, either by the primary laboratory or by a national HPV reference laboratory (NRL). MethodsThere were 116 initially HPV-negative cervical specimens (31 histopathology specimens and 85 liquid-based cytology samples) sent to the Swedish HPV Reference Laboratory for re-testing. Based on the results, an international QA guidance was developed through an iterative consensus process. ResultStandard PCR testing detected HPV in 55.2 % (64/116) of initially “HPV-negative” samples. Whole genome sequencing of PCR-negative samples identified HPV in an additional 7 samples (overall 61.2 % HPV positivity). Reasons for failure to detect HPV in an HSIL+ lesion are listed and guidance to identify cases for extended re-testing, including which information should be included when referring samples to an NRL are presented. ConclusionMonitoring the proportion of and reasons for failure to detect HPV in HSIL+ will help support high performance and quality improvement of HPV testing services. We encourage implementation of QA strategies based on re-analysis of “HPV negative” HSIL+ samples.

Research agenda and priorities for Australian and New Zealand paramedicine: A Delphi consensus study

Introduction: The systematic development of a research agenda is essential for coordinated, collaborative, and efficient research endeavours in any discipline. The aim of this study was to create and prioritise a stakeholder-informed, consensus-derived paramedicine research agenda for Australia and New Zealand. Methods: The study utilised a modified Delphi consensus method consisting of three phases. Phase 1, the findings of which were previously published, consisted of a survey of Australian and New Zealand paramedicine stakeholders to inform the subsequent consensus process. Phase 2 contained three Delphi rounds involving key paramedicine profession stakeholders to generate a research agenda. Panellists were asked to rate their agreement with the inclusion of each item using a 5-point Likert scale. Consensus was defined as 80% agreement signalled by ‘ Strongly Agree’ and ‘ Agree’ responses. Phase 3 involved one additional round of voting to determine the importance and thus establish priorities amongst the final list of agenda items. Results: There were 341 responses to the survey in Phase 1 and thematic analysis produced a provisional agenda consisting of 109 perceived research priorities. Sixty-three key paramedicine profession stakeholders were invited to Phases 2 and 3, of which 56 (88.9%) completed all three rounds in Phase 2, and 43 (68.3%) completed the final Phase 3. Thirty-seven items achieved consensus and were subsequently prioritised constituting the final research agenda. Panellists gave the highest priority to ‘Paramedics role in broader healthcare system’, ‘New and emerging roles in for paramedics’, ‘Patient safety’, ‘System improvement’, and ‘Clinical reasoning processes and models’. Conclusion: Using a modified Delphi consensus method and drawing from a broad range of stakeholders, a 37-item Australian and New Zealand paramedicine research agenda with item prioritisation was developed. The agenda serves to inform industry and other key stakeholders to guide their research endeavours ultimately leading to meaningful and tangible impact within the paramedicine profession.

Pragmatic Trial Design to Compare Real-world Effectiveness of Different Treatments for Inflammatory Bowel Diseases: The PRACTICE-IBD European Consensus.

Pragmatic studies designed to test interventions in everyday clinical settings can successfully complement the evidence from registration and explanatory clinical trials. The European consensus project PRACTICE-IBD was developed to identify essential criteria and address key methodological issues needed to design valid, comparative, pragmatic studies in inflammatory bowel diseases [BDs]. Statements were issued by a panel of 11 European experts in IBD management and trial methodology, on four main topics: [I] study design; [II] eligibility, recruitment and organisation, flexibility; [III] outcomes; [IV] analysis. The consensus process followed a modified Delphi approach, involving two rounds of assessment and rating of the level of agreement [1 to 9; cut-off ≥7 for approval] with the statements by 18 additional European experts in IBD. At the first voting round, 25 out of the 26 statements reached a mean score ≥7. Following the discussion that preceded the second round of voting, it was decided to eliminate two statements and to split one into two. At the second voting round, 25 final statements were approved: seven for study design; six for eligibility, recruitment and organisation, flexibility; eight for outcomes; and four for analysis. Pragmatic, randomised, clinical trials can address important questions in IBD clinical practice, and may provide complementary, high-level evidence, as long as they follow a methodologically rigorous approach. These 25 statements intend to offer practical guidance in the design of high-quality, pragmatic, clinical trials that can aid decision making in choosing a management strategy for IBDs.

Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trial.

Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.

Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children".

The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.

Capturing the Range of Disease Involvement in Localized Scleroderma: The Localized Scleroderma Total Severity Scale.

Juvenile localized scleroderma (jLS) is a chronic autoimmune disease commonly associated with poor outcomes, including contractures, hemiatrophy, uveitis, and seizures. Despite improvements in treatment, >25% of patients with jLS have functional impairment. To improve patient evaluation, our workgroup developed the Localized scleroderma Total Severity Scale (LoTSS), an overall disease severity measure. LoTSS was developed as a weighted measure by a consensus process involving literature review, surveys, case vignettes, and multicriteria decision analysis. Feasibility was assessed in larger Childhood Arthritis and Rheumatology Research Alliance groups. Construct validity with physician assessment and inter-rater reliability was assessed using case vignettes. Additional evaluation was performed in a prospective patient cohort initiating treatment. LoTSS severity items were organized into modules that reflect jLS disease patterns, with modules for skin, extracutaneous, and craniofacial manifestations. Construct validity of LoTSS was supported by a strong positive correlation with the Physician Global Assessment (PGA) of severity and damage and weak positive correlation with PGA-Activity, as expected. LoTSS was responsive, with a small effect size identified. Moderate-to-excellent inter-rater reliability was demonstrated. LoTSS was able to discriminate between patient subsets, with higher scores identified in those with greater disease burden and functional limitation. We developed a new LS measure for assessing cutaneous and extracutaneous severity and have shown it to be reliable, valid, and responsive. LoTSS is the first measure that assesses and scores all the major extracutaneous manifestations in LS. Our findings suggest LoTSS could aid assessment and management of patients and facilitate outcome evaluation in treatment studies.

Management of bipolar disorder in South Africa: National Department of Health essential medicine selection and treatment algorithms

Background. Bipolar disorder (BD) is a severe mental illness associated with multimorbidity, psychosocial disability and significant public health issues. However, guideline heterogeneity clouds therapeutic decisions, particularly in relapse prevention. Polypharmacy and poor health outcomes are common. For low- and middle-income countries, deciding which medicines to procure and how to treat BD in an integrated manner remains elusive. Although South Africa (SA) is committed to universal health coverage, the estimated treatment gap for mental disorders in the public health sector is 91%. An Essential Medicines List (EML) enables equitable access to medicines, while Standard Treatment Guidelines (STGs) facilitate rational prescribing and quality care. Objectives. To describe the medicine selection process for the treatment of BD in the SA public health sector, and the treatment algorithms developed to guide integrated care. Methods. Evidence-based medicine principles, stakeholder consultation and consensus decision-making were used. The existing (2015) BD guideline and stakeholder comments were reviewed by a ministerially appointed expert review committee, following which a research question with eligibility criteria was formed, and rapid systematic evidence synthesis conducted. PubMed and Cochrane databases were searched for systematic reviews of randomised controlled trials and observational studies of acute and maintenance treatment in BD, with an additional PubMed search for primary research. Quality of the systematic reviews was appraised using the 11-item assessment of multiple systematic reviews. After costing to ensure affordability, final recommendations were made to the National EML Committee (NEMLC) using the strength of recommendation taxonomy classification. Following approval by the NEMLC, proposed medicines were incorporated into the 2019 National Department of Health Adult Hospital STGs. As the STGs are updated every 3 years, stakeholder input was sought in 2021 and 2023, with no changes to the medicine selection. Results. Seven systematic reviews and one observational study were included in the evidence synthesis. Six medicines were selected as essential for maintenance treatment: lithium, valproate, lamotrigine, olanzapine, quetiapine and clozapine. While risperidone and benzodiazepines were retained for acute mania, carbamazepine and fluoxetine were removed from acute depression. Treatment algorithms for predominantly manic and depressive courses of illness were constructed to encourage person-centred care, aiming for euthymia, individual functioning and relapse prevention. Conclusion. Evidence-based medicine principles enabled the NEMLC to select a range of essential medicines for the management of BD in a middle-income country. Local monitoring and evaluation are needed to inform future editions of the STGs and EML.

Development of an exercise therapy referral clinical support tool for patients with osteoporosis at risk for falls.

The purpose of this study was to develop a clinical support tool for osteoporosis clinic providers to support risk assessment and referrals for evidence-based exercise therapy programs. A sequential Delphi method was used with a multidisciplinary group of national falls experts, to provide consensus on referral to exercise therapy for patients at risk for falls. The Delphi study included a primary research team, expert panel, and clinical partners to answer the questions: (1) "What patient characteristics are needed to develop a clinical support tool?"; (2) "What are the recommended exercise referrals for patients with osteoporosis at risk for falls?" The consensus process consisted of two rounds with 8 weeks between meetings. Two qualitative researchers analyzed the data using a modified version of a matrix analysis approach. The following were the most important variables to include when determining exercise therapy referrals for patients with osteoporosis: Patient history and demographics, falls history over the last year, current physical function and balance, caregiver and transportation status, socioeconomic and insurance status, and patient preference. Potential exercise therapy referrals included one-on-one physical therapy, group physical therapy, home health, community-based exercise programs, and not acceptable for exercise therapy. Patient characteristics including patient history, physical function and balance performance, socioeconomic and insurance status, and patient preference for exercise therapy are important to inform both the medical provider and patient with osteoporosis to choose the most appropriate exercise therapy referral. Adoption of the algorithmic suggestions may have a significant impact on uptake and adherence to exercise therapy, ultimately improving patient physical function and reducing falls risk.

Variations in services and intervention pathways for traumatic stress in Welsh prisons: A national survey.

Both Post-Traumatic Stress Disorder and Complex Post-Traumatic Stress Disorder are prevalent in prison settings. Both often go undetected and untreated, while prisoners who already suffered previous trauma may be re-traumatised upon imprisonment. The current study aimed to conduct a national survey of all Welsh prisons to gather information about existing services and treatments for traumatic stress. The survey identified variation within Welsh prisons with regard to NICE-recommended evidence-based therapies. It is therefore recommended that there needs to be development of a pathway of Post-Traumatic Stress Disorder and Complex Post-Traumatic Stress Disorder in the prison system which should be achieved through a consensus process of both frontline staff and experts in the field.

Transformative synergy: SSEHCET—bridging mobile edge computing and AI for enhanced eHealth security and efficiency

Blockchain technologies (BCT) are utilized in healthcare to facilitate a smart and secure transmission of patient data. BCT solutions, however, are unable to store data produced by IoT devices in smart healthcare applications because these applications need a quick consensus process, meticulous key management, and enhanced eprivacy standards. In this work, a smart and secure eHealth framework SSEHCET (Smart and Secure EHealth Framework using Cutting-edge Technologies) is proposed that leverages the potentials of modern cutting-edge technologies (IoT, 5G, mobile edge computing, and BCT), which comprises six layers: 1) The sensing layer-WBAN consists of medical sensors that normally are on or within the bodies of patients and communicate data to smartphones. 2) The edge layer consists of elements that are near IoT devices to collect data. 3) The Communication layer leverages the potential of 5G technology to transmit patients' data between multiple layers efficiently. 4) The storage layer consists of cloud servers or other powerful computers. 5) Security layer, which uses BCT to transmit and store patients' data securely. 6) The healthcare community layer includes healthcare professionals and institutions. For the processing of medical data and to guarantee dependable, safe, and private communication, a Smart Agent (SA) program was duplicated on all layers. The SA leverages the potential of BCT to protect patients' privacy when outsourcing data. The contribution is substantiated through a meticulous evaluation, encompassing security, ease of use, user satisfaction, and SSEHCET structure. Results from an in-depth case study with a prominent healthcare provider underscore SSEHCET's exceptional performance, showcasing its pivotal role in advancing the security, usability, and user satisfaction paradigm in modern eHealth landscapes.

First episode psychosis caregiver perspectives on motivational interviewing for loved ones training: A qualitative study.

Past research has found that family involvement in psychosis treatment leads to better patient outcomes. Thus, caregiver communication skills training can be a viable approach to reducing caregiver stress and increasing self-efficacy and communication. The purpose of this qualitative study was to describe family caregivers' perceptions of changes in themselves and their family member with psychosis following their participation in Motivational Interviewing in Loved Ones (MILO), a brief four to five-hour psychoeducational intervention for caregivers. Sixty-three participants in the MILO trials provided written qualitative responses to the prompt, "Since learning the ideas and techniques in this course, what is the most significant change you noticed in yourself, your family, or your relationships?" Responses were collected immediately following MILO participation and 12 weeks later. Qualitative themes were identified through an iterative consensus process. Most participants reported positive changes in multiple domains of their lives. Major themes included: (1) Changes in Self, (2) Changes in Relationships, (3) Changes in Mindset, (4) Use of MILO Skills, and (5) Challenges. Qualitative results support and add context to the previously reported quantitative results from this study. MILO is a promising family intervention that positively influenced family environment and communication in pilot trials. Adaptations of MILO for families outside of a highly educated North American context should be considered.

Clinical Knowledge Model for the Prevention of Healthcare-Associated Venous Thromboembolism.

Knowledge models inform organizational behavior through the logical association of documentation processes, definitions, data elements, and value sets. The development of a well-designed knowledge model allows for the reuse of electronic health record data to promote efficiency in practice, data interoperability, and the extensibility of data to new capabilities or functionality such as clinical decision support, quality improvement, and research. The purpose of this article is to describe the development and validation of a knowledge model for healthcare-associated venous thromboembolism prevention. The team used FloMap, an Internet-based survey resource, to compare metadata from six healthcare organizations to an initial draft model. The team used consensus decision-making over time to compare survey results. The resulting model included seven panels, 41 questions, and 231 values. A second validation step included completion of an Internet-based survey with 26 staff nurse respondents representing 15 healthcare organizations, two electronic health record vendors, and one academic institution. The final knowledge model contained nine Logical Observation Identifiers Names and Codes panels, 32 concepts, and 195 values representing an additional six panels (groupings), 15 concepts (questions), and the specification of 195 values (answers). The final model is useful for consistent documentation to demonstrate the contribution of nursing practice to the prevention of venous thromboembolism.

Updated Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury: Mental Health Recommendations.

Objective: After sustaining a moderate to severe traumatic brain injury (MSTBI), individuals often experience comorbid mental health conditions that can impair the rehabilitation and recovery process. The objective of this initiative was to update recommendations on the assessment and management of mental health conditions for the Canadian Clinical Practice Guideline for the Rehabilitation of Adults with MSTBI (CAN-TBI 2023). Design: A systematic search was conducted by the Evidence-Based Review of Moderate to Severe Acquired Brain Injury to identify new and relevant articles. Expert Panel reviewed and discussed the new and existing evidence, evaluated its quality, and added, removed, or modified recommendations and tools as needed. A consensus process was followed to achieve agreement on recommendations. Results: CAN-TBI 2023 includes 20 recommendations regarding best practices for the assessment and management of mental health conditions post-MSTBI. About 17 recommendations were updated, 1 new recommendation was formed, and 2 recommendations remained unchanged. The Guideline emphasizes the importance of screening and assessment of mental health conditions throughout the rehabilitation continuum. The Expert Panel recommended incorporating multimodal treatments that include pharmacological and nonpharmacological approaches to manage mental health concerns. Conclusion: The CAN-TBI 2023 recommendations for the assessment and management of mental health conditions should be used to inform clinical practice. Additional high-quality research in this area is needed, as 13 recommendations are based on level C evidence, 4 on level B evidence, and 3 on level A evidence.

Development of a recommendations document in an emergency context

Italy is a destination country for a growing international migration, accounting for 8.4% of the total population. The COVID-19 pandemic has increased the difficulties in accessing healthcare services among immigrants, and barriers due to linguistic and cultural differences had a significant impact during the pandemic. This paper presents the methodology used in the project 'Epidemiological surveillance and control of COVID-19 in metropolitan urban areas for the containment of SARS-CoV-2 circulation in the immigrant population in Italy', carried out with the technical and financial support of the Italian Ministry of Health. This methodology is aimed to identify and select statements available in the literature, transferable to the Italian context, on the topic of interventions deemed useful in reducing the impact of the COVID-19 pandemic on the foreign population in urban/metropolitan settings.In February 2022, a systematic search was conducted in databases such as Medline, Embase, and Web of Science, as well as on national and international websites (WHO, Italian Institute of Health, and CDC), and on 'RecMap' (included in the 'COVID19 Recommendations' website) to identify guidelines containing recommendations on the management and prevention of COVID-19 among immigrants. The selected recommendations were divided into intervention areas (infection control, vaccination, screening, planning and monitoring, healthcare systems). In the first phase, a group of researchers independently assessed the inclusion of recommendations through three rounds of consensus. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool was used to assess the quality of the included guidelines. In the second phase, an external group of experts independently evaluated the relevance of the included recommendations using a Likert scale. The document is the result of a collaborative work based on evidence from the literature available until that time. The adaptation and adoption of recommendations already formulated by other international organizations on the topic of preparedness and response to the COVID-19 pandemic, evaluated through a consensus process with experts, can be a valid method aimed at producing documents to inform and guide those involved in the care of immigrants in Italy, as well as promoting inclusive forms of prevention in emergency contexts.

Modified Clavien-Dindo-Sink Classification System for operative complications in adult spine surgery.

Currently there is no standardized mechanism to describe or compare complications in adult spine surgery. Thus, the purpose of the present study was to modify and validate the Clavien-Dindo-Sink complication classification system for applications in spine surgery. The Clavien-Dindo-Sink complication classification system was evaluated and modified for spine surgery by four fellowship-trained spine surgeons using a consensus process. A distinct group of three fellowship-trained spine surgeons completed a randomized electronic survey grading 71 real-life clinical case scenarios. The survey was repeated 2 weeks after its initial completion. Fleiss' and Cohen's kappa (κ) statistics were used to evaluate interrater and intrarater reliabilities, respectively. Overall, interobserver reliability during the first and second rounds of grading was excellent with a κ of 0.847 (95% CI 0.785-0.908) and 0.852 (95% CI 0.791-0.913), respectively. In the first round, interrater reliability ranged from good to excellent with a κ of 0.778 for grade I (95% CI 0.644-0.912), 0.698 for grade II (95% CI 0.564-0.832), 0.861 for grade III (95% CI 0.727-0.996), 0.845 for grade IV-A (95% CI 0.711-0.979), 0.962 for grade IV-B (95% CI 0.828-1.097), and 0.960 for grade V (95% CI 0.826-1.094). Intraobserver reliability testing for all three independent observers was excellent with a κ of 0.971 (95% CI 0.944-0.999) for rater 1, 0.963 (95% CI 0.926-1.001) for rater 2, and 0.926 (95% CI 0.869-0.982) for rater 3. The Modified Clavien-Dindo-Sink Classification System demonstrates excellent interrater and intrarater reliability in adult spine surgery cases. This system provides a useful framework to better communicate the severity of spine-related complications.