UNASSIGNED: Second-generation oral H1-antihistamines, including bilastine, represent the emerging treatments of allergic rhinitis (including rhinoconjunctivitis) and chronic urticaria in both adults and children. This study analyses available evidence supporting the use of bilastine amongst second-generation antihistamines for the symptomatic treatment of allergic rhinitis and urticaria in adults and children.
UNASSIGNED: Consensus amongst experts from 17 countries on the ideal treatment of rhinitis and urticaria, and the specific role of bilastine was measured by means of a modified Delphi process. A total of 12 statements were voted on by the experts using a five-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = undecided; 4 = agree; 5 = strongly agree). The definition of consensus was set at a minimum of 80% concordance for 4+5 scores (agree or strongly agree).
UNASSIGNED: All proposed statements reached consensus, with a concordance of ≥98% for five statements and ≥96% for seven.
UNASSIGNED: The wide consensus obtained for the proposed statements suggests a prominent role for bilastine in the management of allergic rhinitis and urticaria.

UNASSIGNED: Cardiac arrest research has not received as much scientific attention as research on other topics. Here, we aimed to identify cardiac arrest research barriers from the perspective of an international group of early career researchers.
UNASSIGNED: Attendees of the 2022 international masterclass on cardiac arrest registry research accompanied the Global Out-of-Hospital Cardiac Arrest Registry collaborative meeting in Utstein, Norway, and used an adapted hybrid nominal group technique to obtain a diverse and comprehensive perspective. Barriers were identified using a web-based questionnaire and discussed and ranked during an in-person follow-up meeting. After each response was discussed and clarified, barriers were categorized and ranked over two rounds. Each participant scored these from 1 (least significant) to 5 (most significant).
UNASSIGNED: Nine participants generated 36 responses, forming seven overall categories of cardiac arrest research barriers. \"Allocated research time\" was ranked first in both rounds. \"Scientific environment\", including appropriate mentorship and support systems, ranked second in the final ranking. \"Resources\", including funding and infrastructure, ranked third. \"Access to and availability of cardiac arrest research data\" was the fourth-ranked barrier. This included data from the cardiac arrest registries, medical devices, and clinical studies. Finally, \"uniqueness\" was the fifth-ranked barrier. This included ethical issues, patient recruitment challenges, and unique characteristics of cardiac arrest.
UNASSIGNED: By identifying cardiac arrest research barriers and suggesting solutions, this study may act as a tool for stakeholders to focus on helping early career researchers overcome these barriers, thus paving the road for future research.

BACKGROUND: Use of nursing-sensitive quality indicators (QIs) is one way to monitor the quality of care in nursing homes (NHs). The aim of this study was to develop a consensus list of nursing-sensitive QIs for Norwegian NHs.
METHODS: A narrative literature review followed by a non-in-person, two-round, six-step modified Delphi survey was conducted. A five-member project group was established to draw up a list of nursing-sensitive QIs from a preliminary list of 24 QIs selected from Minimum Data Set (2.0) (MDS) and the international Resident Assessment Instrument for Long-Term Care Facilities (interRAI LTCF). We included scientific experts (researchers), clinical experts (healthcare professionals in NHs), and experts of experience (next-of-kin of NH residents). The experts rated nursing-sensitive QIs in two rounds on a seven-point Likert scale. Consensus was based on median value and level of dispersion. Analyses were conducted for four groups: 1) all experts, 2) scientific experts, 3) clinical experts, and 4) experts of experience.
RESULTS: The project group drew up a list of 20 nursing-sensitive QIs. Nineteen QIs were selected from MDS/interRAI LTCF and one (\'systematic medication review\') from the Norwegian quality assessment system IPLOS (\'Statistics linked to individual needs of care\'). In the first and second Delphi round, 44 experts (13 researchers, 17 healthcare professionals, 14 next-of-kin) and 28 experts (8 researchers, 10 healthcare professionals, 10 next-of-kin) participated, respectively. The final consensus list consisted of 16 nursing-sensitive QIs, which were ranked in this order by the \'all expert group\': 1) systematic medication review, 2) pressure ulcers, 3) behavioral symptoms, 4) pain, 5) dehydration, 6) oral/dental health problems, 7) urinary tract infection, 8) fecal impaction, 9) depression, 10) use of aids that inhibit freedom of movement, 11) participation in activities of interest, 12) participation in social activities, 13) decline in activities of daily living, 14) weight loss, 15) falls, and 16) hearing loss without the use of hearing aids.
CONCLUSIONS: Multidisciplinary experts were able to reach consensus on 16 nursing-sensitive QIs. The results from this study can be used to implement QIs in Norwegian NHs, which can improve the quality of care.

BACKGROUND: Instability after reverse shoulder arthroplasty (RSA) is one of the most frequent complications and remains a clinical challenge. Current evidence is limited by small sample size, single-center, or single-implant methodologies that limit generalizability. We sought to determine the incidence and patient-related risk factors for dislocation after RSA, using a large, multicenter cohort with varying implants.
METHODS: A retrospective, multicenter study was performed involving 15 institutions and 24 American Shoulder and Elbow Surgeons members across the United States. Inclusion criteria consisted of patients undergoing primary or revision RSA between January 2013 and June 2019 with minimum 3-month follow-up. All definitions, inclusion criteria, and collected variables were determined using the Delphi method, an iterative survey process involving all primary investigators requiring at least 75% consensus to be considered a final component of the methodology for each study element. Dislocations were defined as complete loss of articulation between the humeral component and the glenosphere and required radiographic confirmation. Binary logistic regression was performed to determine patient predictors of postoperative dislocation after RSA.
RESULTS: We identified 6621 patients who met inclusion criteria with a mean follow-up of 19.4 months (range: 3-84 months). The study population was 40% male with an average age of 71.0 years (range: 23-101 years). The rate of dislocation was 2.1% (n = 138) for the whole cohort, 1.6% (n = 99) for primary RSAs, and 6.5% (n = 39) for revision RSAs (P < .001). Dislocations occurred at a median of 7.0 weeks (interquartile range: 3.0-36.0 weeks) after surgery with 23.0% (n = 32) after a trauma. Patients with a primary diagnosis of glenohumeral osteoarthritis with an intact rotator cuff had an overall lower rate of dislocation than patients with other diagnoses (0.8% vs. 2.5%; P < .001). Patient-related factors independently predictive of dislocation, in order of the magnitude of effect, were a history of postoperative subluxations before radiographically confirmed dislocation (odds ratio [OR]: 19.52, P < .001), primary diagnosis of fracture nonunion (OR: 6.53, P < .001), revision arthroplasty (OR: 5.61, P < .001), primary diagnosis of rotator cuff disease (OR: 2.64, P < .001), male sex (OR: 2.21, P < .001), and no subscapularis repair at surgery (OR: 1.95, P = .001).
CONCLUSIONS: The strongest patient-related factors associated with dislocation were a history of postoperative subluxations and having a primary diagnosis of fracture nonunion. Notably, RSAs for osteoarthritis showed lower rates of dislocations than RSAs for rotator cuff disease. These data can be used to optimize patient counseling before RSA, particularly in male patients undergoing revision RSA.

BACKGROUND: The aim of this study was to design and validate a new checklist and standardized scenario for assessing providers\' performance during Newborn Life Support (NLS).
METHODS: We invited twelve experts in Neonatology to take part in a three-step Delphi process. They rated the importance of each item of a newly designed assessment tool to evaluate participants\' performance during Newborn Life Support independently on a numeric rating scale from 1 to 5 (1 = lowest; 5 = highest) and were able to give additional comments. All items achieving a mean rating below four after the third round were deleted. For the reliability of the checklist, we calculated interrater reliability.
RESULTS: Using a standardized Delphi process, we revised the initial checklist according to the experts\' ratings and comments. The final assessment tool includes 38 items covering all relevant steps during NLS. The mean expert rating of all items was 4.40. Interrater reliability showed substantial agreement between the two raters in the first draft (κ = 0.80) as well as in the final draft of the checklist (κ = 0.73).
CONCLUSIONS: We designed a feasible assessment tool for evaluating performance during NLS. We proved the checklist to be valid and reasonable using a Delphi validation process and calculating interrater reliability.

BACKGROUND: Both patient and implant related variables have been implicated in the incidence of acromial (ASF) and scapular spine fractures (SSF) following reverse shoulder arthroplasty (RSA); however, previous studies have not characterized nor differentiated risk profiles for varying indications including primary glenohumeral arthritis with intact rotator cuff (GHOA), rotator cuff arthropathy (CTA), and massive irreparable rotator cuff tear (MCT). The purpose of this study was to determine patient factors predictive of cumulative ASF/SSF risk for varying preoperative diagnosis and rotator cuff status.
METHODS: Patients consecutively receiving RSA between January 2013 and June 2019 from 15 institutions comprising 24 members of the American Shoulder and Elbow Surgeons (ASES) with primary, preoperative diagnoses of GHOA, CTA and MCT were included for study. Inclusion criteria, definitions, and inclusion of patient factors in a multivariate model to predict cumulative risk of ASF/SSF were determined through an iterative Delphi process. The CTA and MCT groups were combined for analysis. Consensus was defined as greater than 75% agreement amongst contributors. Only ASF/SSF confirmed by clinical and radiographic correlation were included for analysis.
RESULTS: Our study cohort included 4764 patients with preoperative diagnoses of GHOA, CTA, or MCT with minimum follow-up of 3 months (range: 3-84). The incidence of cumulative stress fracture was 4.1% (n = 196). The incidence of stress fracture in the GHOA cohort was 2.1% (n = 34/1637) compared to 5.2% (n = 162/3127) (P < .001) in the CTA/MCT cohort. Presence of inflammatory arthritis (odds ratio [OR] 2.90, 95% confidence interval [CI] 1.08-7.78; P = .035) was the sole predictive factor of stress fractures in GHOA, compared with inflammatory arthritis (OR 1.86, 95% CI 1.19-2.89; P = .016), female sex (OR 1.81, 95% CI 1.20-2.72; P = .007), and osteoporosis (OR 1.56, 95% CI 1.02-2.37; P = .003) in the CTA/MCT cohort.
CONCLUSIONS: Preoperative diagnosis of GHOA has a different risk profile for developing stress fractures after RSA than patients with CTA/MCT. Though rotator cuff integrity is likely protective against ASF/SSF, approximately 1/46 patients receiving RSA with primary GHOA will have this complication, primarily influenced by a history of inflammatory arthritis. Understanding risk profiles of patients undergoing RSA by varying diagnosis is important in counseling, expectation management, and treatment by surgeons.

Allergic rhinoconjunctivitis and chronic urticaria are common histamine-driven diseases, exerting detrimental effects on cognitive functions, sleep, daily activities, and quality of life. Non-sedating second-generation H1-antihistamines are the first-line treatment of choice. Aim of the study was to define the role of bilastine among second-generation H1-antihistamines in the treatment of allergic rhinoconjunctivitis and urticaria in patients of different ages.
An international Delphi study was carried out to assess consensus among experts from 17 European and extra-European countries on three main topics: 1) Burden of disease; 2) Current treatment options; 3) Specific characteristics of bilastine among second-generation antihistamines.
Here, we present the results obtained for a selection of 15 out of 27 consensus statements, focused on disease burden, role of second-generation antihistamines and bilastine profile. The rate of concordance was ≥98% for 4 statements, ≥ 96% for 6, ≥ 94% for 3, and ≥90% for 2.
The high degree of agreement obtained suggests a wide awareness of the burden of allergic rhinoconjunctivitis and chronic urticaria among experts from all over the world and reflects a broad consensus on the role of second-generation antihistamines in general and of bilastine in particular for their management.

The sample size calculation is an important step in designing randomised controlled trials. For a trial comparing a control and an intervention group, where the outcome is binary, the sample size calculation requires choosing values for the anticipated event rates in both the control and intervention groups (the effect size), and the error rates. The Difference ELicitation in TriAls guidance recommends that the effect size should be both realistic, and clinically important to stakeholder groups. Overestimating the effect size leads to sample sizes that are too small to reliably detect the true population effect size, which in turn results in low achieved power. In this study, we use the Delphi approach to gain consensus on what the minimum clinically important effect size is for Balanced-2, a randomised controlled trial comparing processed electroencephalogram-guided \'light\' to \'deep\' general anaesthesia on the incidence of postoperative delirium in older adults undergoing major surgery.
Delphi rounds were conducted using electronic surveys. Surveys were administered to two stakeholder groups: specialist anaesthetists from a general adult department in Auckland City Hospital, New Zealand (Group 1), and specialist anaesthetists with expertise in clinical research, identified from the Australian and New Zealand College of Anaesthetist\'s Clinical Trials Network (Group 2). A total of 187 anaesthetists were invited to participate (81 from Group 1 and 106 from Group 2). Results from each Delphi round were summarised and presented in subsequent rounds until consensus was reached (>70% agreement).
The overall response rate for the first Delphi survey was 47% (88/187). The median minimum clinically important effect size was 5.0% (interquartile range: 5.0-10.0) for both stakeholder groups. The overall response rate for the second Delphi survey was 51% (95/187). Consensus was reached after the second round, as 74% of respondents in Group 1 and 82% of respondents in Group 2 agreed with the median effect size. The combined minimum clinically important effect size across both groups was 5.0% (interquartile range: 3.0-6.5).
This study demonstrates that surveying stakeholder groups using a Delphi process is a simple way of defining a minimum clinically important effect size, which aids the sample size calculation and determines whether a randomised study is feasible.

A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children\'s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening.
A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group.
A total of 60 statements were graded by 128 clinicians in the first round and 132 in the second round. Consensus was reached on 30 out of 60 statements in the first round and an additional 12 in the seond. This was summarized in a consensus statement and distilled into a flowchart to guide clinical practice.
We identified agreement in an area of medicine that has a long history of controversy and varied practice. None of the areas of consensus are based on high-quality evidence. This document is thus a framework to guide clinical practice and on which high-quality clinical trials can be developed.Cite this article: Bone Joint J 2023;105-B(2):209-214.

Recurrent infections of upper and lower respiratory tract have an important clinical and economic impact, which can be reduced through appropriate preventive measures, including the use of immunomodulating agents, such as OM-85, which proved to be effective and safe in both adults and children. Although OM-85 can be useful for the prevention of respiratory tract infections, it is still underused in clinical practice. In order to evaluate the level of awareness of the disease burden of recurrent respiratory infections in adults and children and to assess the level of agreement on the prophylactic and therapeutic approach to the disease, including the use of immunomodulants, a Delphi study was performed. A board of six experts in the field of respiratory infections was appointed to elaborate a series of statements covering four main topics (disease, prevention, OM-85, and future strategies), which were thereafter voted by a panel of 30 experts. Results showed that prevention is unanimously recognized as the most important intervention to reduce disease burden, and the use of immunomodulation to improve the effectiveness of vaccination is gaining increasing favor among clinicians. In this respect, OM-85 is recognized as the most studied immunomodulating agent currently available, whose efficacy and safety make it a valuable tool to optimize the management of recurrent respiratory infections in both adults and children. In particular, the combined use of OM-85 and influenza vaccine was recognized as an effective and safe approach to improve the current prevention strategies in order to reduce the burden of recurrent respiratory infections.