Planning and Reporting Effective Web-Based RAND/UCLA Appropriateness Method Panels: Literature Review and Preliminary Recommendations.

BACKGROUND: The RAND/UCLA Appropriateness Method (RAM), a variant of the Delphi Method, was developed to synthesize existing evidence and elicit the clinical judgement of medical experts on the appropriate treatment of specific clinical presentations. Technological advances now allow researchers to conduct expert panels on the internet, offering a cost-effective and convenient alternative to the traditional RAM. For example, the Department of Veterans Affairs recently used a web-based RAM to validate clinical recommendations for de-intensifying routine primary care services. A substantial literature describes and tests various aspects of the traditional RAM in health research; yet we know comparatively less about how researchers implement web-based expert panels. OBJECTIVE: The objectives of this study are twofold: (1) to understand how the web-based RAM process is currently used and reported in health research and (2) to provide preliminary reporting guidance for researchers to improve the transparency and reproducibility of reporting practices. METHODS: The PubMed database was searched to identify studies published between 2009 and 2019 that used a web-based RAM to measure the appropriateness of medical care. Methodological data from each article were abstracted. The following categories were assessed: composition and characteristics of the web-based expert panels, characteristics of panel procedures, results, and panel satisfaction and engagement. RESULTS: Of the 12 studies meeting the eligibility criteria and reviewed, only 42% (5/12) implemented the full RAM process with the remaining studies opting for a partial approach. Among those studies reporting, the median number of participants at first rating was 42. While 92% (11/12) of studies involved clinicians, 50% (6/12) involved multiple stakeholder types. Our review revealed that the studies failed to report on critical aspects of the RAM process. For example, no studies reported response rates with the denominator of previous rounds, 42% (5/12) did not provide panelists with feedback between rating periods, 50% (6/12) either did not have or did not report on the panel discussion period, and 25% (3/12) did not report on quality measures to assess aspects of the panel process (eg, satisfaction with the process). CONCLUSIONS: Conducting web-based RAM panels will continue to be an appealing option for researchers seeking a safe, efficient, and democratic process of expert agreement. Our literature review uncovered inconsistent reporting frameworks and insufficient detail to evaluate study outcomes. We provide preliminary recommendations for reporting that are both timely and important for producing replicable, high-quality findings. The need for reporting standards is especially critical given that more people may prefer to participate in web-based rather than in-person panels due to the ongoing COVID-19 pandemic.

Eliciting uncertainty for complex parameters in model-based economic evaluations: quantifying a temporal change in the treatment effect.

BACKGROUND: In model-based economic evaluations, the effectiveness parameter is often informed by studies with a limited duration of follow-up, requiring extrapolation of the treatment effect over a longer time horizon. Extrapolation from short-term data alone may not adequately capture uncertainty in that extrapolation. This study aimed to use structured expert elicitation to quantify uncertainty associated with extrapolation of the treatment effect observed in a clinical trial. METHODS: A structured expert elicitation exercise was conducted for an applied study of a podiatry intervention designed to reduce the rate of falls and fractures in the elderly. A bespoke web application was used to elicit experts' beliefs about two outcomes (rate of falls and odds of fracture) as probability distributions (priors), for two treatment options (intervention and treatment as usual) at multiple time points. These priors were used to derive the temporal change in the treatment effect of the intervention, to extrapolate outcomes observed in a trial. The results were compared with extrapolation without experts' priors. RESULTS: The study recruited thirty-eight experts (geriatricians, general practitioners, physiotherapists, nurses, and academics) from England and Wales. The majority of experts (32/38) believed that the treatment effect would depreciate over time and expressed greater uncertainty than that extrapolated from a trial-based outcome alone. The between-expert variation in predicted outcomes was relatively small. CONCLUSIONS: This study suggests that uncertainty in extrapolation can be informed using structured expert elicitation methods. Using structured elicitation to attach values to complex parameters requires key assumptions and simplifications to be considered.

Novel tech throws knock-out punch to ECG improving GP referral decisions to cardiology.

PURPOSE: In a comparator study, designed with assistance from the Food and Drug Administration, a State-of-the-Art (SOTA) ECG device augmented with automated analysis, the comparator, was compared with a breakthrough technology, Cardio-HART (CHART). METHODS: The referral decision defined by physician reading biosignal-based ECG or CHART report were compared for 550 patients, where its performance is calculated against the ground truth referral decision. The ground truth was established by cardiologist consensus based on all the available measurements and findings including echocardiography (ECHO). RESULTS: The results confirmed that CHART analysis was far more effective than ECG only analysis: CHART reduced false negative rates 15.8% and false positive (FP) rates by 5%, when compared with SOTA ECG devices. General physicians (GP's) using CHART saw their positive diagnosis rate significantly increased, from ~10% to ~26% (260% increase), and the uncertainty rate significantly decreased, from ~31% to ~1.9% (94% decrease). For cardiology, the study showed that in 98% of the cases, the CHART report was found to be a good indicator as to what kind of heart problems can be expected (the 'start-point') in the ECHO examination. CONCLUSIONS: The study revealed that GP use of CHART resulted in more accurate referrals for cardiology, resulting in fewer true negative or FP-healthy or mildly abnormal patients not in need of ECHO confirmation. The indirect benefit is the reduction in wait-times and in unnecessary and costly testing in secondary care. Moreover, when used as a start-point, CHART can shorten the echocardiograph examination time.

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

Neuropsychological autopsy of testamentary capacity: Methodology and issues in the elderly.

The forensic assessment of testamentary capacity is a topical issue given the prevalence of dementia illnesses and the increase in the complexity of modern financial and family structures. Although a contemporaneous assessment would be desirable, the majority of situations require a retrospective assessment of the mental state a deceased individual. Neuropsychologists, independently or as part of a board of consultants, are, therefore, frequently requested to give an expert opinion of the competence of cognitively impaired elderly testators.This paper offers a guide for carrying out a neuropsychological autopsy, namely the process of posthumous evaluation, for determining testamentary capacity. Taking into account the recent literature on the assessment of testamentary capacity, we propose a three-phase procedure for carrying out the neuropsychological autopsy in the forensic context. The neuropsychological autopsy of testamentary capacity is based on the meticulous, chronologically structured evaluation of any medical documents, available psychometric data, along with the critical examination of any source of information about the cognitive level of functioning of the deceased person at the time of the will.

Uncertainty in experts' judgments exposes the vulnerability of research reporting anecdotes on animals' cognitive abilities.

Expertise in science, particularly in animal behaviour, may provide people with the capacity to provide better judgments in contrast to lay people. Here we explore whether experts provide a more objective, accurate and coherent evaluation of a recently reported anecdote on Atlantic puffin (Fratercula arctica) "tool use" (recorded on video) which was published in a major scientific journal but was received with some scepticism. We relied on citizen science and developed a questionnaire to measure whether experts in ethology and ornithology and lay people agree or disagree on (1) the description of the actions that they observe (the bird takes a stick in its beak), (2) the possible goal of the action (nest-building or grooming) and (3) the intentional component of the action (the bird took the stick into its beak in order to scratch itself). We hypothesised that contrary to the lay people, experts are more critical evaluators that is they are more inclined to report alternative actions, like nest building, or are less likely to attributing goal-directedness to the action in the absence of evidence. In contrast, lay people may be more prone to anthropomorphise utilising a teleological and intentional stance. Alternatively, all three groups of subjects may rely on anthropomorphism at similar levels and prior expertise does not play a significant role. We found that no major differences among the evaluators. At the group levels, respondents were relatively uncertain with regard to the action of the bird seen on the video but they showed some individual consistency with regard to the description of the action. Thus, we conclude that paradoxically, with regard to the task our experts are typically not experts in the strict sense of the definition, and suggest that anecdotal reports should not be used to argue about mental processes.

Testing the waters: An investigation of the impact of hot tubbing on experts from referral through testimony.

OBJECTIVE: The present research examined whether concurrent expert testimony ("hot tubbing") and court-appointed testimony reduced adversarial allegiance in clinical experts' judgments compared with traditional adversarial expert testimony. HYPOTHESES: We predicted Hypothesis 1: Defense experts would render more not responsible judgments and lower ratings of criminal responsibility than would prosecution experts; Hypothesis 2: Adversarial allegiance effects on experts' judgments would be heightened for adversarial experts and attenuated for concurrent experts over time; Hypothesis 3: Adversarial and concurrent experts would report higher dissonance than would court-appointed experts and adversarial experts' ratings would increase over time, concurrent experts' ratings would decrease, and court-appointed experts' ratings would remain unchanged. METHOD: Clinicians and advanced clinical doctoral students conducted simulated criminal responsibility evaluations for the prosecution, defense, or court. We categorized participants as favoring the prosecution or defense based on their preexisting attitudes and randomly assigned them to the adversarial, concurrent, or court-appointed expert testimony conditions. Participants completed a dichotomous responsibility judgment, strength of responsibility ratings, and cognitive dissonance measure after initial evidence review (n = 93), report completion (n = 52), and testimony (n = 48). Concurrent experts generated a joint report outlining areas of agreement and disagreement before providing testimony. RESULTS: Concurrent testimony did not eliminate adversarial allegiance. Adversarial and concurrent experts' perceptions of responsibility did not significantly differ (d = .04, 95% CI [-.64, .71]) or change over time (ηp2 = .03); however, prosecution experts-across testimony types-rated the defendant as significantly more responsible than did defense experts (d = 1.87, 95% CI [1.06, 2.67]). Concurrent and adversarial experts did not differ in their reports and minimally differed in testimony content. CONCLUSIONS: Experts who initially favored the prosecution or defense showed adversarial allegiance regardless of expert testimony method, and we observed no attenuation of this bias over the course of their case involvement. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Expert recommendations and clinical considerations in the use of onasemnogene abeparvovec gene therapy for spinal muscular atrophy.

Spinal muscular atrophy (SMA) is an autosomal recessive, neurodegenerative disease caused by biallelic mutations in the survival motor neuron 1 (SMN1) gene. SMA is characterized by motor neuron degeneration, resulting in progressive muscle atrophy and weakness. Before the emergence of disease-modifying therapies, children with the most severe form of SMA would never achieve the ability to sit independently. Only 8% survived beyond 20 months of age without permanent ventilator support. One such therapy, onasemnogene abeparvovec, an adeno-associated virus-based gene replacement therapy, delivers functional human SMN through a one-time intravenous infusion. In addition to substantially improving survival, onasemnogene abeparvovec was found to increase motor milestone attainment and reduce the need for respiratory or nutritional support in many patients. This expert opinion provides recommendations and practical considerations on the patient-centered decisions to use onasemnogene abeparvovec. Recommendations include the need for patient-centered multidisciplinary care and patient selection to identify those with underlying medical conditions or active infections to reduce risks. We also describe the importance of retesting patients with elevated anti-adeno-associated virus serotype 9 antibodies. Recommendations for prednisolone tapering and monitoring for potential adverse events, including hepatotoxicity and thrombotic microangiopathy, are described. The need for caregiver education on managing day-to-day care at time of treatment and patient- and family-centered discussions on realistic expectations are also recommended. We detail the importance of following standard-of-care guidance and long-term monitoring of all children with SMA who have received one or more disease-modifying therapy using registries. We also highlight the need for presymptomatic or early symptomatic treatment of this disorder.

A Gastroenterologist' clinical experience in COVID 19 and in-hospital mortality and length of stay analysis.

OBJECTIVES: COVID19 pandemic has forced physicians from different specialties to assist cases overload. Our aim is to assess gastroenterologist's assistance in COVID-19 by assessing mortality, ICU admission, and length of stay, and seek for risk factors for in-hospital mortality and longer hospital stay. METHODS: A total of 41 COVID-19 patients assisted by gastroenterologist (GI cohort) and 137 assisted by pulmonologist, internal medicine practitioners, and infectious disease specialists (COVID expert cohort) during October-November 2020 were prospectively collected. Clinical, demographic, imaging, and laboratory markers were collected and compared between both cohorts. Bivariate analysis and logistic regression were performed to search for risk factors of mortality and longer hospital stays. RESULTS: A total of 27 patients died (15.1%), 11 were admitted to ICU (6.1%). There were no differences between cohorts in mortality (14.6% vs 15.4%;p = 0.90), ICU admission (12.1% vs 4%;p = 0.13), and length of stay (6.67 ± 4 vs 7.15 ± 4.5 days; p = 0.58). PaO2/FiO2 on admission (OR 0.991;CI95% 0.984-0.998) and age > 70 (OR 17.54;CI95% 3.93-78.22) were independently related to mortality. Age > 70, history of malignancy, diabetes, and cardiovascular disease were related to longer hospital stays (p < 0.001, p = 0.03, p = 0.04, p = 0.02 respectively). CONCLUSIONS: COVID-19 assistance was similar between gastroenterologist and COVID experts when assessing mortality, ICU admission, and length of stay. Age>70 and decreased PaO2/FiO2 on admission were independent risk factors of mortality. Age and several comorbidities were related to longer hospital stay.

Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.

Regulatory changes have been enacted in the United States (US) and European Union (EU) to encourage the development of new treatments for pediatric cancer. Here, we review some of the factors that have hampered the development of pediatric cancer treatments and provide a comparison of the US and EU regulations implemented to address this clinical need. We then provide some recommendations for each stage of the oncology drug development pathway to help researchers maximize their chance of successful drug development while complying with regulations. A key recommendation is the engagement of key stakeholders such as regulatory authorities, pediatric oncologists, academic researchers, patient advocacy groups, and a Pediatric Expert Group early in the drug development process. During drug target selection, sponsors are encouraged to consult the Food and Drug Administration (FDA), European Medicines Agency (EMA), and the FDA target list, in addition to relevant US and European consortia that have been established to characterize and prioritize oncology drug targets. Sponsors also need to carefully consider the resourcing requirements for preclinical testing, which include ensuring appropriate access to the most relevant databases, clinical samples, and preclinical models (cell lines and animal models). During clinical development, sponsors can account for the pharmacodynamic (PD)/pharmacokinetic (PK) considerations specific to a pediatric population by developing pediatric formulations, selecting suitable PD endpoints, and employing sparse PK sampling or modeling/simulation of drug exposures where appropriate. Additional clinical considerations include the specific design of the clinical trial, the potential inclusion of children in adult trials, and the value of cooperative group trials.

In the last few decades, great progress has been made in developing new treatments for adult cancers. However, development of new treatments for childhood cancers has been much slower. To encourage drug companies (sponsors) to develop effective treatments for childhood cancer, authorities in the United States (US) and Europe have made new rules for drug development. Under these new rules, sponsors developing drugs for specific cancers in adults have to consider whether the target of that drug also causes cancers in children. If this is the case, sponsors have to carry out clinical studies of their drug in children who have cancer that is caused by the same drug target. In this article, we describe some reasons for why drug development for childhood cancers has been slow and the rules created to address this problem in the US and Europe. We share some recommendations to help sponsors maximize their chances of developing an effective drug in children while satisfying the new rules. Specifically, sponsors need to be aware of the differences between studying drugs in adults versus children and how these influence the way the drug is tested. We make several recommendations for each stage of the development process, beginning with what is needed even before human studies begin. Finally, we highlight some issues that sponsors need to think about during drug development, from the preclinical stage (testing drugs in cells and animals) through to clinical testing in adults and pediatric patients with cancer.

What is the optimal outcome after endoscopic sinus surgery in the treatment of chronic rhinosinusitis? A consultation of Canadian experts.

OBJECTIVES: Many experts feel that in the absence of well-defined goals for success, they have an easier time identifying failure. As success ought to not be defined only by absence of failure, we aimed to define optimal outcomes for endoscopic sinus surgery (ESS) in chronic rhinosinusitis (CRS) by obtaining expert surgeon perspectives. METHODS: A total of 12 surgeons participated in this targeted consultation. Face to face semi-structured interviews were performed with expert surgeons in the field of CRS and ESS. General impressions and personal definitions of acceptable operative success and optimal operative outcomes were compiled and summarized. RESULTS: According to an expert survey, patients' main objectives are an improvement in their chief complain, a general improvement in quality of life (QoL), and a better overall symptomatic control. The most important aspects of endoscopy for defining a successful intervention were an adequate mucus circulation, a healthy mucosa, minimal edema, and patency of all explored cavities or ostia. In the assessment of surgical outcomes, it was determined that both objective and patient reported data must be carefully examined, with more attention given to subjective outcomes. CONCLUSIONS: According to data gathered from a Canadian expert consultation, a definition of success must be based on both subjective data and nasal endoscopy. We propose to define an acceptable outcome as either a subjective improvement of at least the minimal clinically improvement difference of a validated patient reported outcome questionnaire, along with a satisfactory endoscopic result (1) or a complete subjective resolution with a sub-optimal endoscopy (2).

Evidence-Based Assessment of Genes in Dilated Cardiomyopathy.

BACKGROUND: Each of the cardiomyopathies, classically categorized as hypertrophic cardiomyopathy, dilated cardiomyopathy (DCM), and arrhythmogenic right ventricular cardiomyopathy, has a signature genetic theme. Hypertrophic cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy are largely understood as genetic diseases of sarcomere or desmosome proteins, respectively. In contrast, >250 genes spanning >10 gene ontologies have been implicated in DCM, representing a complex and diverse genetic architecture. To clarify this, a systematic curation of evidence to establish the relationship of genes with DCM was conducted. METHODS: An international panel with clinical and scientific expertise in DCM genetics evaluated evidence supporting monogenic relationships of genes with idiopathic DCM. The panel used the Clinical Genome Resource semiquantitative gene-disease clinical validity classification framework with modifications for DCM genetics to classify genes into categories on the basis of the strength of currently available evidence. Representation of DCM genes on clinically available genetic testing panels was evaluated. RESULTS: Fifty-one genes with human genetic evidence were curated. Twelve genes (23%) from 8 gene ontologies were classified as having definitive (BAG3, DES, FLNC, LMNA, MYH7, PLN, RBM20, SCN5A, TNNC1, TNNT2, TTN) or strong (DSP) evidence. Seven genes (14%; ACTC1, ACTN2, JPH2, NEXN, TNNI3, TPM1, VCL) including 2 additional ontologies were classified as moderate evidence; these genes are likely to emerge as strong or definitive with additional evidence. Of these 19 genes, 6 were similarly classified for hypertrophic cardiomyopathy and 3 for arrhythmogenic right ventricular cardiomyopathy. Of the remaining 32 genes (63%), 25 (49%) had limited evidence, 4 (8%) were disputed, 2 (4%) had no disease relationship, and 1 (2%) was supported by animal model data only. Of the 16 evaluated clinical genetic testing panels, most definitive genes were included, but panels also included numerous genes with minimal human evidence. CONCLUSIONS: In the curation of 51 genes, 19 had high evidence (12 definitive/strong, 7 moderate). It is notable that these 19 genes explain only a minority of cases, leaving the remainder of DCM genetic architecture incompletely addressed. Clinical genetic testing panels include most high-evidence genes; however, genes lacking robust evidence are also commonly included. We recommend that high-evidence DCM genes be used for clinical practice and that caution be exercised in the interpretation of variants in variable-evidence DCM genes.

Telephonic Medical Toxicology Service in a Low-Resource Setting: Setup, Challenges, and Opportunities.

Poisoning and envenomation are a global health problem for which the mortality burden is shouldered heavily by middle- and low-income countries that often lack poison prevention programs and medical toxicology expertise. Although telehealth or teleconsult services have been used to bridge the expertise gap between countries for multiple specialties, the use of medical toxicology teleconsult services across borders has been limited. We aim to describe the use of a United States-based medical toxicology teleconsult service to support patient care at a hospital in a middle-income country that lacks this expertise. This report outlines the logistics involved in setting up such a service, including the challenges and opportunities that emerged from establishing medical toxicology teleconsult service in a low-resource setting.

Perioperative management of patients with pulmonary hypertension undergoing non-cardiothoracic, non-obstetric surgery: a systematic review and expert consensus statement.

BACKGROUND: The risk of complications, including death, is substantially increased in patients with pulmonary hypertension (PH) undergoing anaesthesia for surgical procedures, especially in those with pulmonary arterial hypertension (PAH) and chronic thromboembolic PH (CTEPH). Sedation also poses a risk to patients with PH. Physiological changes including tachycardia, hypotension, fluid shifts, and an increase in pulmonary vascular resistance (PH crisis) can precipitate acute right ventricular decompensation and death. METHODS: A systematic literature review was performed of studies in patients with PH undergoing non-cardiac and non-obstetric surgery. The management of patients with PH requiring sedation for endoscopy was also reviewed. Using a framework of relevant clinical questions, we review the available evidence guiding operative risk, risk assessment, preoperative optimisation, and perioperative management, and identifying areas for future research. RESULTS: Reported 30 day mortality after non-cardiac and non-obstetric surgery ranges between 2% and 18% in patients with PH undergoing elective procedures, and increases to 15-50% for emergency surgery, with complications and death usually relating to acute right ventricular failure. Risk factors for mortality include procedure-specific and patient-related factors, especially markers of PH severity (e.g. pulmonary haemodynamics, poor exercise performance, and right ventricular dysfunction). Most studies highlight the importance of individualised preoperative risk assessment and optimisation and advanced perioperative planning. CONCLUSIONS: With an increasing number of patients requiring surgery in specialist and non-specialist PH centres, a systematic, evidence-based, multidisciplinary approach is required to minimise complications. Adequate risk stratification and a tailored-individualised perioperative plan is paramount.

Achieving better outcomes for schizophrenia patients in Hong Kong: Strategies for improving treatment adherence.

Recent research on second-generation long-acting injectable antipsychotics (LAI SGAs) has proven its effectiveness in minimizing medication nonadherence problem and reducing relapses. Administered by medical professionals, making quick detection of nonadherence possible, long-acting injectable antipsychotics (LAIs) facilitate immediate intervention and recovery process, and thus are favored by psychiatrists. Despite a higher initial cost with LAIs, the subsequent schizophrenia-related health costs for hospitalizations and outpatients are greatly reduced. With reference to guidelines published by psychiatric associations around the globe, this article looks at scenarios in Hong Kong on the management of severe mentally ill patients with regard to the use of a host of psychosocial interventions as well as LAI SGAs as a preferable treatment. In particular, it examines the benefits of using LAI SGAs for Hong Kong patients who demonstrated high nonadherence treatment rates due to their social environment. It assesses the rationale behind the early usages of LAI SGAs, which help to provide better recovery outcomes for patients.

Use and Cost of Orthosis in Conservative Treatment of Acute Thoracolumbar Fractures: A Survey of European and North American Experts.

STUDY DESIGN: Survey study. OBJECTIVE: Assess practices and opinions of spine specialists from Europe and North America on orthosis use in adult patients with acute thoracolumbar (TL) fractures. Evaluate cost of the devices. SUMMARY OF BACKGROUND DATA: Although orthosis are traditionally used in conservative treatment of TL fractures, recent systematic reviews showed no benefit in patient's outcomes. METHODS: A search for contact authors with publications on spine fractures from all European and North American countries was performed. An online questionnaire was sent on demographic data, practice setting, mean number of fractures treated, use of orthosis upon choice for conservative treatment, and average orthosis cost. Data was analyzed based in world regions, economic rank of the country, and health expenditure. RESULTS: We received 130 answers, from 28 European and five North American countries. Most responders had more than 9 years of practice and worked at a public hospital. 6.2% did not prescribe a brace in any patient with acute TL fractures conservatively treated and 11.5% brace all patients. In a scale from 1 to 5, 21 considered that there is no/low benefit (1) and 14 that bracing is essential (5), with a mean of 3.18. Europeans use orthosis less commonly than North Americans (P < 0.05). Orthosis mean cost was $611.4 ±â€Š716.0, significantly higher in North America compared with Europe and in high income, when compared with upper middle income countries (both P < 0.05). Although hospital costs were not evaluated, orthosis is costlier when it involves admission of the patient (P < 0.05). An increase in orthosis cost associated with higher gross domestic product (GDP) per capita and higher health expenditure was found. CONCLUSION: More than 90% of spine specialists still use orthosis in conservative treatment of adult patients with acute TL fractures. Orthosis cost vary significantly between continents, and it is influenced by the country's economy.Level of Evidence: 4.

Intraocular Lens Power Calculations in Eyes with Previous Corneal Refractive Surgery: Review and Expert Opinion.

Intraocular lens (IOL) power calculations are less accurate in eyes that have undergone corneal refractive surgery. A wide range of methods have been proposed. We reviewed the methods and outcomes of IOL power calculations in eyes with previous LASIK, excimer laser photorefractive keratectomy (PRK), or radial keratotomy (RK). The PubMed database was searched for articles that (1) discuss methods and outcomes of IOL power calculation in eyes with previous corneal refractive surgery and (2) evaluate the outcomes of toric, multifocal, or extended depth-of-focus (EDOF) IOLs in these eyes. We excluded review articles, case reports or case studies, and non-English reports. Seventy full-text articles were included in this review. Three categories of methods exist based on whether and how they use historical data acquired before the corneal refractive surgery. The American Society of Cataract and Refractive Surgery (ASCRS) postrefractive IOL calculator incorporates many commonly used methods. In eyes with previous myopic LASIK or PRK, hyperopic LASIK or PRK, and RK, 0% to 85%, 38.1% to 71.9%, and 29% to 87.5% of eyes, respectively, showed refractive prediction errors within ±0.5 diopter (D); in eyes with toric IOL implantation that met certain inclusion criteria, 80%, 84%, and 69% of eyes, respectively, achieved postoperative astigmatism of 0.50 D or less. Intraocular lenses with negative spherical aberration (SA) will reduce the positive corneal spherical aberration induced in eyes by myopic LASIK or PRK or by RK. Intraocular lenses with 0 SA on average best match corneal SA in eyes with prior hyperopic LASIK or PRK. Studies have reported excellent outcomes of postrefractive eyes implanted with multifocal or EDOF IOLs; however, corneal topographic enrollment criteria were not specified. Despite availability of new measurement technologies and development of new IOL calculation formulas, further advances are needed to improve outcomes of cataract surgery in eyes that have undergone corneal refractive surgery. Tools like the ASCRS postrefractive IOL calculator are useful for the clinician by incorporating a variety of formulas. Toric, EDOF, and multifocal IOLs may provide excellent outcomes in selected cases that meet certain corneal topographic criteria.

Expert Opinion on Management of Intraocular Inflammation, Retinal Vasculitis, and Vascular Occlusion after Brolucizumab Treatment.

PURPOSE: Recent reports have described a spectrum of uncommon findings of intraocular inflammation (IOI), retinal vasculitis, or retinal vascular occlusion in patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal injection (IVI) of brolucizumab. We present guidance on the clinical presentation of this spectrum and propose recommendations for management of these events. DESIGN: PubMed literature review and expert opinion panel. PARTICIPANTS: A working group of international medical experts and Novartis medical personnel. METHODS: The working group deliberated on the clinical presentations and used a 3-pronged approach to develop management recommendations based on (1) critical appraisal of scientific literature; (2) clinical insights from the HAWK and HARRIER trials, postmarketing reports, and assessments from an independent Safety Review Committee (SRC); and (3) their clinical experience. MAIN OUTCOME MEASURES: Management recommendations for a spectrum of ocular inflammatory events after treatment with brolucizumab or other anti-vascular endothelial growth factors (VEGFs). RESULTS: Based on insights gained from the available information and the expertise of the contributors, recommendations were proposed for ocular examinations, imaging modalities, and treatment strategies for management of this spectrum of events. Patients should be educated to promptly report any relevant or persistent symptoms after IVI to facilitate timely intervention. Patients diagnosed with IOI should be evaluated for concomitant retinal vasculitis or retinal vascular occlusive events. Clinical examination can be augmented with multimodal imaging techniques, including widefield imaging, fluorescein angiography (with peripheral sweeps), and OCT. Once confirmed, the ongoing brolucizumab treatment should be suspended and intensive treatment with potent corticosteroids (topical, subtenon, intravitreal, or systemic) is recommended, which may be supplemented with other treatment strategies depending on the severity. Based on the clinical outcome of these events, individualized treatment with locally available standard of care should be considered for the underlying nAMD. CONCLUSIONS: These recommendations emphasize the need for early diagnosis, prompt and timely intervention, intensive treatment, and frequent monitoring to minimize the risk of progression of these events. The proposed recommendations may facilitate a consistent management approach of this spectrum of ocular inflammatory events should they arise in nAMD after treatment with brolucizumab or other anti-VEGFs.