Inappropriate CT examinations: how much, who and where? Insights from a clinical decision support system (CDSS) analysis.

OBJECTIVE: To assess the appropriateness of Computed Tomography (CT) examinations, using the ESR-iGuide. MATERIAL AND METHODS: A retrospective study was conducted in 2022 in a medium-sized acute care teaching hospital. A total of 278 consecutive cases of CT referral were included. For each imaging referral, the ESR-iGuide provided an appropriateness score using a scale of 1-9 and the Relative Radiation Level using a scale of 0-5. These were then compared with the appropriateness score and the radiation level of the recommended ESR-iGuide exam. DATA ANALYSIS: Pearson's chi-square test or Fisher exact test was used to explore the correlation between ESR-iGuide appropriateness level and physician, patients, and shift characteristics. A stepwise logistic regression model was used to capture the contribution of each of these factors. RESULTS: Most of exams performed were CT head (63.67%) or CT abdominal pelvis (23.74%). Seventy percent of the actual imaging referrals resulted in an ESR-iGuide score corresponding to "usually appropriate." The mean radiation level for actual exam was 3.2 ± 0.45 compared with 2.16 ± 1.56 for the recommended exam. When using a stepwise logistic regression for modeling the probability of non-appropriate score, both physician specialty and status were significant (p = 0.0011, p = 0.0192 respectively). Non-surgical and specialist physicians were more likely to order inappropriate exams than surgical physicians. CONCLUSIONS: ESR-iGuide software indicates a substantial rate of inappropriate exams of CT head and CT abdominal-pelvis and unnecessary radiation exposure mainly in the ED department. Inappropriate exams were found to be related to physicians' specialty and seniority. CLINICAL RELEVANCE STATEMENT: These findings underscore the urgent need for improved imaging referral practices to ensure appropriate healthcare delivery and effective resource management. Additionally, they highlight the potential benefits and necessity of integrating CDSS as a standard medical practice. By implementing CDSS, healthcare providers can make more informed decisions, leading to enhanced patient care, optimized resource allocation, and improved overall healthcare outcomes. KEY POINTS: • The overall mean of appropriateness for the actual exam according to the ESR-iGuide was 6.62 ± 2.69 on a scale of 0-9. • Seventy percent of the actual imaging referrals resulted in an ESR-iGuide score corresponding to "usually appropriate." • Inappropriate examination is related to both the specialty of the physician who requested the exam and the seniority status of the physician.

Priority setting for health technology adoption at the national level: Lessons learned over 25 years' experience.

BACKGROUND: Limited health budgets and continual advancement of health technologies require mechanisms for prioritization. Israel, with a publicly funded health service basket, has implemented and optimized such a health technology assessment process since 1999.We describe the process of evaluating technologies according to the Israeli model, analyze its outputs and benefits over two decades of implementation, and compare its key features with international experience. METHODS: Retrospective data were collected between 1998 and 2023, including work processes, committee composition, number of applications submitted and approved by a clinical domain, and yearly cost of the basket. Features were evaluated within the evidence-informed deliberative process (EDP) framework. RESULTS: This national model involves relevant stake holders in a participatory and transparent process, in a timely manner, and is accepted by the public, health professionals, and policy makers, facilitating early adoption of the newest medical technologies. Between 11 and 19 percent of applications are approved for reimbursement annually, mostly pharmaceuticals. On average 26 percent of approved technologies are added to the list without additional budget. Major domains of approved technologies were oncology, cardiology, and neurology. CONCLUSIONS: Israel created a unique model for the expansion of the health service basket. Despite an increasing number of applications and rising costs, the mechanism enables a consensus to be reached on which technologies to fund, while remaining within budget constraints and facilitating immediate implementation. The process, which prioritizes transparency and stake holder involvement, allows just a resource allocation while maximizing the adoption of novel technologies, contributing to an outstanding national level of health despite relatively low health spending.

Socioeconomic and ethnic disparities along five waves of the COVID-19 pandemic: Lessons we have not yet learnt.

PURPOSE: The COVID-19 pandemic, now in its third year, has served as a magnifying glass, exposing the inequitable impact of the outbreak. The study aims to analyze the relationships between the socioeconomic and ethnic characteristics of the population and COVID-19 testing, infection, and vaccination throughout the first five pandemic waves. DESIGN: A secondary analysis of an existing national database was conducted in Israel from March 2020 to May 2022. During the study period, Israel underwent 5 pandemic peaks or waves (March-April 2020, September-October 2020, January-February 2021, September 2021, and January-February 2022). METHODS: Data on tests performed, confirmed COVID-19 cases, and uptake of vaccine doses one through four during the study period, were analyzed by the socioeconomic (SE) cluster (scale of 1 to 10) and ethnicity (Jewish, Arab, mixed Jewish- Arab ethnicity) of the residents' local authority. RESULTS: COVID-19 testing rate gradually increased from the lowest to the highest SE clusters, with rates 3.2 times higher in the second highest, compared with the lowest cluster. People living in Jewish localities were tested twice more than those in Arab or mixed localities. The rate of confirmed cases was 1.9, 3.0, 6.3, and 4.3 times higher, respectively, among cluster 1 (the lowest) compared with cluster 9 (second highest) in the first, second, third, and fourth pandemic waves, respectively. Rates among people living in Arab or mixed localities were higher compared with those living in Jewish localities in 3 of the 5 waves. Vaccine uptake revealed a clear social gradient, with the percentage of the population being vaccinated gradually increasing from cluster 1 (the lowest) to the higher clusters. The relative difference between the lowest and highest SE clusters increased from 2.4 in the first vaccine dose to 5.5 in the third and fourth doses. Ethnic disparities also grew with vaccine dose, with a Jewish to an Arab rate ratio of 1.1, 1.2, 1.6, and 4.5 for vaccine doses 1,2,3, and 4, respectively. CONCLUSIONS: Covering 26 consecutive months of the COVID-19 pandemic at the national level, the current study demonstrates that despite high accessibility of tests and vaccines to the entirety of the population and tailored outreach efforts, socioeconomic, and ethnic disparities not only failed to diminish, but they even widened along the five pandemic waves. CLINICAL RELEVANCE: The pandemic exposed the vulnerability of the weakest segments of the population. Therefore, the combined action of the Ministry of Health, health providers, and local authorities is required to further adapt health messages to the cultural characteristics of diverse populations, to equip the health professionals with practical tools to promote healthy choices among the vulnerable populations, and to build communities that promote healthy lifestyles. The pandemic has highlighted the importance of reducing health disparities and building trust between vulnerable populations and the healthcare system during "normal" or routine times, to better prepare for times of emergencies, such as the current pandemic.

Timely childhood vaccination in Israel: a national retrospective study of ethnic and socioeconomic disparities.

A large proportion of children do not receive vaccines within the recommended timeframe. This study examined ethnic and socioeconomic differences in age-appropriate immunization of children in Israel, where immunization is freely available. Percent of children receiving MMR/V at 12-13 months, and four doses of DTP/IPV/Hib by 18 months were obtained from the National Programme for Quality Measures between 2015 and 2018. Ethnic group (Jewish vs Arab) (defined by proxy by the neighbourhood in which the clinic was located), neighbourhood socioeconomic status and peripherality were obtained. Rates of MMR vaccination were 61% in the Jewish and 82% in the Arab population; for DPT/IPV/Hib 75% in the Jewish, compared to 92% in the Arab population. These patterns were stable over time. Lowest rates occurred in the most peripheral areas for Arab children, and in urban areas for Jewish children. Differences between ethnic groups were significant at higher SES levels. Greater adherence to the vaccination schedule occurred in the Arab minority in contrast to studies showing lower vaccination in ethnic minorities elsewhere. Lower immunization rates among rural Arab children suggest a need for improved access to clinics. Efforts should be directed towards lower SES groups, while emphasizing the importance of timely vaccination in wealthier groups in order to achieve herd immunity.

Clinical decision support system recommendations: how often do radiologists and clinicians accept them?

OBJECTIVE: To assess the acceptance and reliability of clinical decision support system (CDSS) imaging referral scores (ESR iGuide). METHODS: A pilot study was conducted in a tertiary hospital. Four different experts were invited to rate 40 simulated clinical cases on a 5-level scale, for the level of agreement with the ESR iGuide's recommended procedures. In cases of disagreement, physicians were asked to indicate the reason. Descriptive measures were calculated for the level of agreement. We also explored the degree of agreement between four different specialists, and examined the cases in which clinicians disagreed with ESR iGuide best practice recommendations. RESULTS: The mean rating of the four experts for the 40 clinical simulated cases was 4.17 ± 0.65, median 4.25 (on a scale of 1-5). All four raters totally agreed with the system recommendation in 75% of cases. No significant relationship was found between the degree of agreement and the number of indications and the patient's age or gender. In an optimistic scenario, using a binary agree/disagree variable, the Overall Percentage Agreement for the rating of the 40 simulated cases between the four experts was 77.28%. There were a total of 20 disagreements out of 160 cases with the ESR iGuide, of which 7 were among the two radiologists. CONCLUSIONS: CDSS can be an effective tool for guiding the selection of appropriate imaging examinations, thus cutting costs due to unnecessary imaging scans. Since this is a pilot study, further research on a larger scale, preferably at national level, is required. KEY POINTS: • The average of the mean rating of the four experts was 4.17 ± 0.65, median 4.25, on a scale of 1-5 where 5 represents total agreement with the CDSS tool. • In an optimistic scenario, using a binary agree/disagree variable, the Overall Percentage Agreement between the four experts was 77.28%. • Radiologists had fewer disagreements with the recommendations of the CDSS tool than other physicians, indicating a better fit of the support system to radiology experts' perspective.

The effect of the COVID-19 pandemic on non-COVID respiratory ED visits in Israel.

BACKGROUND: The COVID 19 pandemic has had a crucial effect on the patterns of disease and treatment in the healthcare system. This study examines the effect of the COVID-19 pandemic on respiratory ED visits and admissions broken down by age group and respiratory diagnostic category. METHODS: Data on non-COVID related ED visits and hospitalizations from the ED were obtained in a retrospective analysis for 29 acute care hospitals, covering 98% of ED beds in Israel, and analyzed by 5 age groups: under one-year-old, 1-17, 18-44, 45-74 and 75 and over. Diagnoses were classified into three categories: Upper respiratory tract infections (URTI), pneumonia, and COPD or asthma. Data were collected for the whole of 2020, and compared for each month to the average number of cases in the three pre-COVID years (2017-2019). RESULTS: In 2020 compared to 2017-2019, there was a decrease of 34% in non-COVID ED visits due to URTI, 40% for pneumonia and a 35% decrease for COPD and asthma. Reductions occurred in most age groups, but were most marked among infants under a year, during and following lockdowns, with an 80% reduction. Patients over 75 years old displayed a marked drop in URTI visits. Pediatric asthma visits fell during lockdowns, but spiked when restrictions were lifted, accompanied by a higher proportion admitted. The percent of admissions from the ED visits remained mostly stable for pneumonia; the percent of young adults admitted with URTI decreased significantly from March to October. CONCLUSIONS: Changing patterns of ED use were probably due to a combination of a reduced rate of viral diseases, availability of additional virtual services, and avoidance of exposure to the ED environment. Improved hygiene measures during peaks of respiratory infections could be implemented in future to reduce respiratory morbidity; and continued provision of remote health services may reduce overuse of ED services for mild cases.

Missed initial appointments at Israeli child development centres: Rate, reasons, and associated characteristics.

INTRODUCTION: Missed appointments (MAs) at child development centres (ChDCs) cause multiple problems: they preclude timely diagnosis and treatment of both the invited child and children whose appointment was delayed due to overbooking, as well as disrupting efficient organisational management. The aim of this study was to assess the rate and describe the reasons for missed appointments at Israeli ChDCs, and to evaluate the association of socio-demographic, clinical, and administrative variables with MA rates. METHODS: This nested case-control study included all children scheduled for initial appointments (N = 1143) at three centres during 1 year. Parents of children who missed their appointment and a sample of those who attended were interviewed by telephone. RESULTS: The rate of missed appointments was 26.6%, and the most frequent reasons were unexpected events (26.0%) and lack of insurance coverage (23.4%). Variables associated with lower MA rates were: having had ≥3 types of rehabilitative interventions (odds ratios (OR) = 0.26; 95% confidence interval [CI] 0.16-0.44), detailed referral letter (OR = 0.48; 95%CI 0.30-0.75), telephone reminder (OR = 0.37; 95%CI 0.24-0.57) and health maintenance organisations or private insurance coverage (OR = 0.12; 95%CI 0.06-0.17 and OR = 0.56; 95% CI 0.38-0.89, respectively). CONCLUSION: Encouraging physician's referral letters and personal-contact reminders can reduce missed appointments. Understanding the family's and the child's personal characteristics, and the organisational/administrative aspects of missed appointments may guide efforts to ensure timely care for every child.

Childhood Exposure to Low to Moderate Doses of Ionizing Radiation and the Risk of Vascular Diseases.

In the Tinea Capitis Study (Israel, 1966-2011), we assessed the association between childhood exposure to low to moderate doses of ionizing radiation (IR) to the head and neck and the development of vascular diseases (ischemic heart disease, carotid artery stenosis, and stroke) in adulthood. The study included 17,734 individuals from the Tinea Capitis cohort (7,408 irradiated in childhood and 10,326 nonirradiated), insured by Israel's largest health provider. Individual dosimetry was estimated based on measurements made on a head phantom and original treatment records. The mean doses were 1.5, 0.09, 0.78, and 0.017 Gy to brain, thyroid, salivary gland, and breast, respectively. Data on vascular diseases was abstracted from computerized medical records. Using Poisson regressions, we examined the association of radiation with morbidity. Any vascular disease was reported for 2,221 individuals. Adjusted for age, sex, socioeconomic status, smoking, hypertension, and diabetes, exposure to IR increased the risk of developing any vascular diseases (relative risk (RR) = 1.19, 95% confidence interval (CI): 1.09, 1.29), stroke (RR = 1.35, 1.20, 1.53), carotid artery stenosis (RR = 1.32, 1.06, 1.64), and ischemic heart disease (RR = 1.12, 1.01, 1.26). The risk of developing vascular diseases was positively associated with dose and inversely associated with age at exposure. In conclusion, the results indicate that early exposure to low to moderate doses of IR increases the risk of cerebro- and cardiovascular impairments.

Tipping the scales: a theoretical model to describe the differential effects of the COVID-19 pandemic on mortality.

BACKGROUND: The COVID-19 pandemic has resulted in changes in almost every aspect of life. The fatal consequences of the pandemic have been clearly reported, with direct and indirect effects; however, there is some evidence of a positive secondary impact, such as fewer motor accidents, lower influenza burden and reduced air pollution. METHODS/MODEL: We present a model to describe the differing effects of the COVID-19 pandemic on mortality, taking into account external pressures and internal resources and their relationship with resilience and health behaviors, which affect mortality risk, inspired by elements of the salutogenic model. Individuals with lower resources and from more deprived communities are likely to be more negatively affected by the external changes occurring, while those with more resources may be more likely to experience the benefits. Both individual and community resources affect coping and influence both mental and physical health. CONCLUSIONS: Decision makers should consider ways to incorporate the positive changes which occurred as part of the exit strategy. Societies should invest in building resources to improve both individual and community resilience to help people be better prepared and more able to cope and adapt in times of crisis. Special emphasis should be given to weaker populations most affected by external changes, including older people, low socioeconomic groups, those with mental health issues and minority groups, in order to reduce disparities.

Nuclear Cardiology Practice in Asia: Analysis of Radiation Exposure and Best Practice for Myocardial Perfusion Imaging　- Results From the IAEA Nuclear Cardiology Protocols Cross-Sectional Study (INCAPS).

BACKGROUND: This paper examines the current status of radiation exposure to patients in myocardial perfusion imaging (MPI) in Asia.Methods and Results:Laboratories voluntarily provided information on MPI performed over a 1-week period. Eight best practice criteria regarding MPI were predefined by an expert panel. Implementation of ≥6 best practices (quality index [QI] ≥6) was pre-specified as a desirable goal for keeping radiation exposure at a low level. Radiation effective dose (ED) in 1,469 patients and QI of 69 laboratories in Asia were compared against data from 239 laboratories in the rest of the world (RoW). Mean ED was significantly higher in Asia (11.4 vs. 9.6 mSv; P<0.0001), with significantly lower doses in South-East vs. East Asia (9.7 vs. 12.7 mSv; P<0.0001). QI in Asia was lower than in RoW. In comparison with RoW, Asian laboratories used thallium more frequently, used weight-based technetium dosing less frequently, and trended towards a lower rate of stress-only imaging. CONCLUSIONS: MPI radiation dose in Asia is higher than that in the RoW and linked to less consistent use of laboratory best practices such as avoidance of thallium, weight-based dosing, and use of stress-only imaging. Given that MPI is performed in Asia within a diverse array of medical contexts, laboratory-specific adoption of best practices offers numerous opportunities to improve quality of care.

Nuclear Cardiology Practices and Radiation Exposure in the Oceania Region: Results From the IAEA Nuclear Cardiology Protocols Study (INCAPS).

BACKGROUND: There is concern about radiation exposure with radionuclide myocardial perfusion imaging (MPI). This sub-study of the International Atomic Energy Agency (IAEA) Nuclear Cardiology Protocols Study reports radiation doses from MPI, and use of dose-optimisation protocols in Australia and New Zealand (ANZ), and compares them with data from the rest of the world. METHODS: Data were collected from 7911 MPI studies performed in 308 laboratories worldwide in one week in 2013, including 439 MPI studies from 34 ANZ laboratories. For each laboratory, effective radiation dose (ED) and a quality index (QI) score (out of 8) based on pre-specified "best practices" was determined. RESULTS: In ANZ patients, ED ranged from 0.9-17.9 milliSievert (mSv). Median ED was similar in ANZ compared with the rest of the world (10.0 (IQR: 6.5-11.7) vs. 10.0 (IQR 6.4-12.6, P=0.15), as were mean QI scores (5.5±0.7 vs. 5.4±1.3, P=0.84). Use of stress-only imaging (17.6% vs. 31.8% of labs, P=0.09) and weight-based dosing of technetium-99m (14.7% vs. 30.3%, P=0.07) was lower in ANZ compared with the rest of the world but this difference was not statistically significant. Median ED was significantly lower in metropolitan versus non-metropolitan laboratories (10.1 mSv vs. 11.6 mSv, P<0.01), although mean QI scores were similar (5.4±0.8 vs. 5.5±0.7, P=0.75). CONCLUSION: Across ANZ, there is variability in ED from MPI, and use of radiation safety practices, particularly between metropolitan and non-metropolitan laboratories. Overall, ANZ laboratories have a similar median ED to laboratories in the rest of the world.

Current worldwide nuclear cardiology practices and radiation exposure: results from the 65 country IAEA Nuclear Cardiology Protocols Cross-Sectional Study (INCAPS).

AIMS: To characterize patient radiation doses from nuclear myocardial perfusion imaging (MPI) and the use of radiation-optimizing 'best practices' worldwide, and to evaluate the relationship between laboratory use of best practices and patient radiation dose. METHODS AND RESULTS: We conducted an observational cross-sectional study of protocols used for all 7911 MPI studies performed in 308 nuclear cardiology laboratories in 65 countries for a single week in March-April 2013. Eight 'best practices' relating to radiation exposure were identified a priori by an expert committee, and a radiation-related quality index (QI) devised indicating the number of best practices used by a laboratory. Patient radiation effective dose (ED) ranged between 0.8 and 35.6 mSv (median 10.0 mSv). Average laboratory ED ranged from 2.2 to 24.4 mSv (median 10.4 mSv); only 91 (30%) laboratories achieved the median ED ≤ 9 mSv recommended by guidelines. Laboratory QIs ranged from 2 to 8 (median 5). Both ED and QI differed significantly between laboratories, countries, and world regions. The lowest median ED (8.0 mSv), in Europe, coincided with high best-practice adherence (mean laboratory QI 6.2). The highest doses (median 12.1 mSv) and low QI (4.9) occurred in Latin America. In hierarchical regression modelling, patients undergoing MPI at laboratories following more 'best practices' had lower EDs. CONCLUSION: Marked worldwide variation exists in radiation safety practices pertaining to MPI, with targeted EDs currently achieved in a minority of laboratories. The significant relationship between best-practice implementation and lower doses indicates numerous opportunities to reduce radiation exposure from MPI globally.

Evaluating the Accuracy and Impact of the ESR-iGuide Decision Support Tool in Optimizing CT Imaging Referral Appropriateness.

Radiology referral quality impacts patient care, yet factors influencing quality are poorly understood. This study assessed the quality of computed tomography (CT) referrals, identified associated characteristics, and evaluated the ESR-iGuide clinical decision support tool's ability to optimize referrals. A retrospective review analyzed 300 consecutive CT referrals from an acute care hospital. Referral quality was evaluated on a 5-point scale by three expert reviewers (inter-rater reliability κ = 0.763-0.97). The ESR-iGuide tool provided appropriateness scores and estimated radiation exposure levels for the actual referred exams and recommended exams. Scores were compared between actual and recommended exams. Associations between ESR-iGuide scores and referral characteristics, including the specialty of the ordering physician (surgical vs. non-surgical), were explored. Of the referrals, 67.1% were rated as appropriate. The most common exams were head and abdomen/pelvis CTs. The ESR-iGuide deemed 70% of the actual referrals "usually appropriate" and found that the recommended exams had lower estimated radiation exposure compared to the actual exams. Logistic regression analysis showed that non-surgical physicians were more likely to order inappropriate exams compared to surgical physicians. Over one-third of the referrals showed suboptimal quality in the unstructured system. The ESR-iGuide clinical decision support tool identified opportunities to optimize appropriateness and reduce radiation exposure. Implementation of such a tool warrants consideration to improve communication and maximize patient care quality.

Timely care for age-related macular degeneration: a qualitative study among retina specialists in Israel.

BACKGROUND: Age-related macular degeneration (AMD) affects quality of life and independence, and its incidence and prevalence are increasing due to ageing of the population. Access to effective timely treatment can improve vision and reduce incidence of blindness. This study aimed to explore the perspectives of ophthalmologists in the Israeli public healthcare system regarding timely treatment of AMD patients. METHODS: Qualitative semi-structured interviews were conducted in 2020-2021 with 22 senior ophthalmologists, from 10 general hospitals and from two HMOs, representing different geographic regions. All interviewees specialize in retinal diseases and work with AMD patients. Interviews discussed patient pathways involved in the diagnosis and treatment of AMD, access to care, and obstacles to timely care. Thematic analysis was conducted. RESULTS: Based on the interviews, we describe the usual referral and treatment pathways. Themes included regional disparities, long wait times in some areas, a lack of retina specialists, differences in referral pathways, inappropriate use of emergency department to obtain timely treatment, and second-line treatment not fully covered by insurance, most affecting the weakest segments of the population. CONCLUSIONS: Loss of vision incurs high health and societal costs. In the context of insufficient medical manpower in Israel, the healthcare system will need to assess future resources to cope with accumulating burden of AMD cases over time in an ageing population. Precise referral information, and simultaneous referral to imaging and retinal clinics, may minimize delays in treatment. Awareness of AMD symptoms and the importance of early intervention could be highlighted by campaigns, particularly among high-risk groups. HIGHLIGHTS: • Interviews with hospital-based and community ophthalmologists showed regional disparities in AMD treatment, with long wait times and a lack of retina specialists in some areas. • Differences in referral pathways, inappropriate use of emergency department to obtain timely treatment, and second line treatment not fully covered by insurance were highlighted. • The healthcare system will need to assess future resources to cope with accumulating burden of AMD cases over time in an ageing population • Precise referral information, and simultaneous referral to imaging and retinal clinics, may minimize delays in treatment. • Awareness of AMD symptoms and the importance of early intervention should be emphasized in high-risk groups.

Exploring pre-MRI imaging tests: patient survey reveals potential implications for healthcare efficiency in Israel.

BACKGROUND: Medical imaging tests are vital in healthcare but can be costly, impacting national health expenditures. Magnetic resonance imaging (MRI) is a crucial diagnostic tool for assessing medical conditions. However, the rising demand for MRI scans has frequently strained available resources. This study aimed to estimate the prevalence of different imaging tests in individuals who eventually had an MRI, in the Israeli public health system. METHODS: An online survey of patient experience of scheduling an MRI was conducted in January-February 2023, among 557 Israeli adults, representing all four health maintenance organizations (HMOs). All participants had undergone an MRI in the public health system within the past year. RESULTS: Results showed that 60% of participants underwent other imaging tests before their MRI scan. Of those, computed tomography (CT) scans (43%), X-rays (39%), and ultrasounds (32%) were the most common additional imaging procedures. In addition, of the 60% of participants, 23% had undergone more than one prior imaging examination. CONCLUSIONS: These findings highlight the high prevalence of preliminary imaging tests prior to MRI, with many patients undergoing multiple tests for the same problem. The health system may need to evaluate whether current clinical guidelines defining the use of various imaging tests are cost-effective.

Advancing acceptance: assessing acceptance of the ESR iGuide clinical decision support system for improved computed tomography test justification.

Background: A clinical decision support system (CDSS), the European Society of Radiologists (ESR) iGuide, was developed to address gaps in the availability and use of effective imaging referral guidelines. Aim: This study aimed to assess the appropriateness of computed tomography (CT) exams with and without ESR iGuide use, as well as the usability and acceptance of the physician systems. Methods: A retrospective single-center study was conducted in which data from 278 consecutive CT tests referred by physicians were collected in the first phase (T1), and physicians used the ESR iGuide system for imaging referrals in the second phase (T2; n = 85). The appropriateness of imaging referrals in each phase was assessed by two experts, and physicians completed the System Usability Scale. Results: The mean appropriateness level on a scale of 0-9 was 6.62 ± 2.69 at T1 and 7.88 ± 1.4 at T2. When using a binary variable (0-6 = non-appropriate; 7-9 = appropriate), 70.14% of cases were found appropriate at T1 and 96.47% at T2. Surgery physician specialty and post-intervention phase showed a higher likelihood of ordering an appropriate test (p = 0.0045 and p = 0.0003, respectively). However, the questionnaire results indicated low system trust and minimal clinical value, with all physicians indicating they would not recommend collegial use (100%). Conclusion: The study suggests that ESR iGuide can effectively guide the selection of appropriate imaging tests. However, physicians showed low system trust and use, indicating a need for further understanding of CDSS acceptance properties. Maximizing CDSS potential could result in crucial decision-support compliance and promotion of appropriate imaging.

Does clinical decision support system promote expert consensus for appropriate imaging referrals? Chest-abdominal-pelvis CT as a case study.

OBJECTIVES: We assessed the appropriateness of chest-abdominal-pelvis (CAP) CT scan use in the Emergency Department (ED), based on expert physicians and the ESR iGuide, a clinical decision support system (CDSS). METHODS: A retrospective cross-study was conducted. We included 100 cases of CAP-CT scans ordered at the ED. Four experts rated the appropriateness of the cases on a 7-point scale, before and after using the decision support tool. RESULTS: Before using the ESR iGuide the overall mean rating of the experts was 5.2 ± 1.066, and it increased slightly after using the system (5.85 ± 0.911 (p < 0.01)). Using a threshold of 5 (on a 7-level scale), the experts considered only 63% of the tests appropriate before using the ESR iGuide. The number increased to 89% after consultation with the system. The degree of overall agreement among the experts was 0.388 before ESR iGuide consultation and 0.572 after consultation. According to the ESR iGuide, for 85% of the cases, CAP CT was not a recommended option (score 0). Abdominal-Pelvis CT was "usually appropriate" for 65 out of the 85 (76%) cases (score 7-9). 9% of the cases did not require CT as first exam modality. CONCLUSIONS: According to both the experts and the ESR iGuide, inappropriate testing was prevalent, in terms of both frequency of the scans and also inappropriately chosen body regions. These findings raise the need for unified workflows that might be achieved using a CDSS. Further studies are needed to investigate the CDSS contribution to the informed decision-making and increased uniformity among different expert physicians when ordering the appropriate test.

Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA.

OBJECTIVES: US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed independently by the Advisory Committee of Drug Registration (ACDR). In this study, the correlation between the number of discussions at the ACDR and major postapproval variations is examined. DESIGN: This is an observational retrospective comparative cohort study. SETTING: Applications with FDA and/or EMA approval at time of assessment in Israel were included. The timeframe was chosen to allow a minimum of 3 years of postmarketing approval experience for potential major label variations. Data regarding the number of discussions at ACDR were extracted from protocols. Data on postapproval major variations were extracted from the FDA and EMA websites. RESULTS: Between 2014 and 2016, 226 (176 drugs) applications, met the study criteria. 198 (87.6%) and 28 (12.4%) were approved following single and multiple discussions, respectively. A major postapproval variation was recorded in 129 (65.2%) compared with 23 (82.1%) applications approved following single and multiple discussions, respectively (p=0.002). Increased risk for major variation was found for medicines approved following multiple discussions (HR=1.98, 95% CI: 1.26 to 3.09) with a median time of 1.2 years, applications approved based on phase II trials (HR=2.58, 95% CI: 1.72 to 3.87), surrogate endpoints (HR=1.99, 95% CI: 1.44 to 2.74) and oncologic indications (HR=2.48, 95% CI: 1.78 to 3.45). CONCLUSIONS: Multiple ACDR discussions associated with limited supportive data are predictive for major postapproval variations. Moreover, our findings demonstrate that approval by the FDA and/or EMA does not pave the way to automatic approval in Israel. In a substantial per cent of the cases, submission of the same clinical data resulted in different safety and efficacy considerations, requiring additional supporting data in some cases or even rejection of the application in others.

Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines. FDA's fast-track designation and MHRA's marketing authorization under exceptional circumstances (MAEC) allow non-clinical and limited clinical evidence to support approval under these programs. HC's Extraordinary Use New Drug (EUND) pathway allows granting exceptional use authorization with limited clinical evidence. ANVISA, HSA, MTIIR, and TGA do not have standard pathways that allow non-clinical evidence and limited clinical evidence. While there is no definite regulatory pathway for HSA, the current framework for approval does allow flexibility in the type of data (non-clinical or clinical) required to demonstrate the benefit-risk profile of a product. HSA may register a product if the agency is satisfied that the overall benefit outweighs the risk. All Project Orbis Partner (POP) countries have similar programs to the FDA accelerated approval program except ANVISA. Although HSA and MTIIR do not have defined pathways for accelerated approval programs, there are opportunities to request accelerated approval per these agencies. All POP countries have pathways like the FDA priority review except MHRA. Priority review timelines for new drugs range from 120 to 264 calendar days (cd). Standard review timelines for new drugs range from 180 to 365 cd.

[Medical resonance imaging (MRI)--the technology, the regulation and the utilization pattern in Israel].

Medical resonance imaging (MRI) is a technology for imaging and diagnosis of tissues and organs which does not use ionizing radiation. It was developed in the 1960's and 1970's and has been in clinical use since the 1980's. Over the last two decades there has been a substantial increase in utilization of MRI due to: improvements in imaging technology and image processing, the development of new indications for its use, and the increase in availability and accessibility of MRI in several medical fields. However, there is also overutilization of this technology due to: the use of imaging as a substitute for regular physical examinations, repeated examinations for the same medical reason, "defensive" medicine, and due to the public's desire for sophisticated examinations. These issues are all responsible for the increased use of MRI. MRI is an expensive technology and therefore, cost-lowering medical and economic mechanisms are employed to Limit its use. Until recently there were ten MRI scanners in Israel and this review presents their utilization patterns. The number of MRI scanners will double in the coming years. This may improve accessibility in different regions of the country, shorten waiting times, and improve medical diagnosis due to implementation for new indications. An international comparison showed that the number of MRI scanners in Israel is lower than the average number of MRI scanners in OECD countries. However, the utilization of MRI scanners in Israel is high relative to other OECD countries, indicating the high level of efficiency of the Israeli healthcare system.