[THE IMPACT OF REGULATION AND CENTRAL MANAGEMENT ON PATIENT SAFETY IN ISRAEL].

INTRODUCTION: An adverse event is defined as an unwanted and unexpected occurrence in a medical process that may end in harm to the patient. In the USA the number of deaths due to failures reaches 253,000 per year. In Israel, over 10,000 deaths occur per year due to errors in the medical treatment of hospitalized patients, the third most common cause of death after heart disease and cancer. The main cause of failures in medical diagnosis and treatment is the complexity of the medical profession. A large number of caregivers in different medical disciplines are needed to treat one patient, therefore there are many errors, especially regarding communication between therapists. The Israeli health system has been operating with a budget deficit for many years and an addition of at least NIS 20 billion is needed to bring it to optimal functioning. The number of doctors, nurses, and hospital beds per 1000 inhabitants is significantly less than the average of the OECD countries. When there was a 30% increase in the population of Israel it was necessary to enhance the existing situation, with the addition of 7700 hospital beds, but only 1400 were added. This caused a decrease from 2.1 beds per 1000 residents to 1.8 beds per 1000 residents. There is an urgent need to change the elements of treatment safety in the Ministry of Health's strategic plan. An administration for quality, treatment safety, risk management in medicine, and accreditation should be established which, in addition to the care quality division, will include a safety division with investigation and monitoring units and will prepare strategic improvement plans, and a university-level research institute with researchers, computing, statistics, and information gathering units. The institute will receive all reports of adverse events, results of investigations, inspection committees, control and quality committees, relevant verdicts, and updated literature reviews, for research and systemic learning. Strategic plans will be prepared to prevent failures in diagnosis and medical treatment, leading to a decrease in mortality due to adverse events and the significant expenses involved.

[CONFIDENTIALITY OF ADVERSE EVENTS INVESTIGATIONS - THE PRESENT STATUS AND WHAT IS NEEDED].

INTRODUCTION: The goal of the medical staff is to provide proper, effective and efficient treatment to the patient and to take care of his well-being. An error in medical care that causes a serious outcome or mortality, can be considered negligence when the caregiver did not meet the requirements of a reasonable physician for reasonable care and did not take the necessary precautions in providing the treatment, in light of the information available to him. The perception of punishment and compensation due to harm, caused to a patient as a result of a medical error, changed dramatically over the years. Starting with direct and severe punishment according to Hammurabi laws and ending with the "no fault" approach that is accepted widely in some countries. Following an adverse event that occurred in medical treatment, a process should be conducted in order to draw lessons to reduce the likelihood of recurrence of similar incidents in the future, by answering 4 questions: What happened? How did it happen? Why did it happen? and What should be done to prevent similar incidents in the future? The Patient Rights Act does not suggest conducting a safety investigation but recommends an examination board in cases of negligence or error in treatment. By law, the protocols of the examination board are confidential and can be removed by the court in case the protocol contains evidence of importance that is unlikely to be found in the medical record. Lack of confidentiality may cause medical staff to be reluctant of conducting a safety investigation due to fear of using its findings for a lawsuit or appointing an examination board whose conclusions will be reported to the victim and his family. The "no fault" method overcomes these barriers by enabling a thorough safety investigation and has important professional, economic and social aspects with a direct impact on the quality and safety of treatment. The method expands the accessibility of victims to compensation, reduces the number of claims and the burden on the courts. Among additional benefits are transparency and consistency in decisions, promoting patient safety due to physicians' willingness to report failures, reduction in "defensive medicine" and spending in the health care system.

Combined SNA and LDA methods to understand adverse medical events.

OBJECTIVE: To compare primary medical adverse event keywords from reporters (e.g. physicians and nurses) and harm level perspectives to explore the underlying behaviors of medical adverse events using social network analysis (SNA) and latent Dirichlet allocation (LDA) leading to process improvements. DESIGN: Used SNA methods to explore primary keywords used to describe the medical adverse events reported by physicians and nurses. Used LDA methods to investigate topics used for various harm levels. Combined the SNA and LDA methods to discover common shared topic keywords to better understand underlying behaviors of physicians and nurses in different harm level medical adverse events. SETTING: Maccabi Healthcare Community is the second largest healthcare organization in Israel. DATA: 17,868 medical adverse event data records collected between 2000 and 2017. METHODS: Big data analysis techniques using social network analysis (SNA) and latent Dirichlet allocation (LDA). RESULTS: Shared topic keywords used by both physicians and nurses were determined. The study revealed that communication, information transfer, and inattentiveness were the most common problems reported in the medical adverse events data. CONCLUSIONS: Communication and inattentiveness were the most common problems reported in medical adverse events regardless of healthcare professional reporting or harm levels. Findings suggested that an information-sharing and feedback mechanism should be implemented to eliminate preventable medical adverse events. Healthcare institutions managers and government officials should take targeted actions to decrease these preventable medical adverse events through quality improvement efforts.

A prospective, randomised, placebo-controlled, double-masked, three-armed, multicentre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma - the STRONG study: study protocol for a randomised controlled trial.

BACKGROUND: Neovascular glaucoma (NVG) is rare, comprising only 3.9% of all glaucoma cases. The most common cause of NVG is ischaemic central retinal vein occlusion (iCRVO). NVG frequently results in blindness and painful end-stage glaucomatous damage leading to the need for enucleation. Currently, there is no preventive therapy for NVG following iCRVO. Rescue treatments have severe drawbacks. Accordingly, there is a great need for preventing the often visually devastating outcomes of NVG. The STRONG study is designed to test whether the topically active anti-angiogenic agent aganirsen is able to inhibit the formation of neovascularisation leading to the development of secondary NVG in eyes with iCRVO. At the same time, STRONG will provide important information on the natural course of iCRVO and NVG in a large and well-characterised cohort of such patients. METHODS/DESIGN: This protocol describes a phase II/III, prospective, randomised, placebo-controlled, double-masked, three-armed multicentre study for the investigation of aganirsen, a new topical treatment for iCRVO in order to prevent NVG. The study will evaluate the efficacy of two different doses of this newly developed antisense oligonucleotide formulated in an eye emulsion to avoid new vessel formation by blocking insulin receptor substrate-1 (IRS)-1. This leads to subsequent down-regulation of both angiogenic as well as proinflammatory growth factors such as vascular endothelial growth factor (VEGF) and tumour necrosis factor (TNF). Eligible patients (n = 333) will be treated with topical aganirsen or placebo for a period of 24 weeks. They will also be invited to participate in substudies involving analysis of gonioscopic images, detection of biomarkers for NVG and risk factors for iCRVO. DISCUSSION: The STRONG study has the potential to offer a new treatment modality for patients suffering from iCRVO with a high risk of developing NVG. The topical administration can reduce patients' burden and risk related to rescue treatment, such as destructive laser treatment or enucleation, but requires a high level of patient compliance. TRIAL REGISTRATION: EudraCT: 2014-000239-18; ClinicalTrials.gov, ID: NCT02947867 . (Registered on 15 October 2016); see also http://strong-nvg.com .

Analysis of soluble protein contents from the nematocysts of a model sea anemone sheds light on venom evolution.

The nematocyst is one of the most complex intracellular structures found in nature and is the defining feature of the phylum Cnidaria (sea anemones, corals, jellyfish, and hydroids). This miniature stinging organelle contains and delivers venom into prey and foe yet little is known about its toxic components. In the present study, we identified by tandem mass spectrometry 20 proteins released upon discharge from the nematocyst of the model sea anemone Nematostella vectensis. The availability of genomic and transcriptomic data for this species enabled accurate identification and phylogenetic study of these components. Fourteen of these proteins could not be identified in other animals suggesting that they might be the products of taxonomically restricted genes, a finding which fits well their origin from a taxon-specific organelle. Further, we studied by in situ hybridization the localization of two of the transcripts encoding the putative nematocyst venom proteins: a metallopeptidase related to the Tolloid family and a cysteine-rich protein. Both transcripts were detected in nematocytes, which are the cells containing nematocysts, and the metallopeptidase was found also in pharyngeal gland cells. Our findings reveal for the first time the possible venom components of a sea anemone nematocyst and suggest their evolutionary origins.

Developing a tool to preserve eye contact with patients undergoing colonoscopy for pain monitoring.

Colonoscopy has become the leading procedure for early detection and prevention of colorectal cancer. Patients' experience of colonic endoscopic procedures is scarcely reported, even though it is considered a major factor in colorectal cancer screening participation. Pain due to air inflation or stretching the colon with an endoscope is not rare during examination and may be the main obstacle to cooperation and participation in a screening program. We propose a four-stage study for developing a tool dedicated to pain monitoring during colonoscopy, as follows: (1) comparison of patient, nurse, and endoscopist questionnaire responses about patient pain and technical details of the procedure using the PAINAD tool during colonoscopy; (2) observation of the correlation between patients' facial expressions and other parameters (using the short PAINAD); (3) development of a device for continuous monitoring of the patient's facial expression during the procedure; (4) assessment of the usability of such a tool and its contribution to the outcomes of colonoscopy procedures. Early intervention by the staff performing the procedure, in reaction to alerts encoded by this tool, may prevent adverse events during the procedure.

Analysis of 7-year physician-reported adverse events in esophagogastroduodenoscopy.

INTRODUCTION: The number of negligence claims against physicians and health institutes is increasing and has become a serious financial problem. Reporting adverse events became a mandatory behavior for quality assurance purposes and for preparing potential claims. AIM: To evaluate endoscopists' reports on adverse events in esophagogastroduodenoscopy (EGD). METHODS: We analyzed all the reports of gastroenterologists on EGD adverse events to the risk management authority, between January 1, 2000, and December 31, 2006. Clinical and epidemiological details about the patients, procedures, and adverse events were computed, discussed, and evaluated. RESULTS: Thirty-nine cases of EGD adverse events were reported. There were 15 cases (38.5%) of men, and the average age was 58.1±21.6 years. In this period, 314,803 EGDs were performed by the institutes concerned, and the number of adverse events was 0.5 to 2.3 for 10,000 EGDs per year. Perforation occurred in 1 of 31,480 procedures, bleeding in 1 of 39,350 procedures, and respiratory complications in 1 of 157,401 procedures. Trauma to teeth happened in 1:31,480 procedures. CONCLUSIONS: This is the first study in Israel about physicians' reports of EGD adverse events. Reporting adverse events in EGD should be encouraged for improving patients' safety.

Complications in colonoscopy: analysis of 7-year physician-reported adverse events.

INTRODUCTION: The number of malpractice claims against physicians and health institutes in Israel is increasing continuously, as in the rest of the Western world. This trend became a serious financial burden. AIM: In this study we analyzed reports of gastroenterologists on colonoscopy adverse events to the medical malpractice insurer, as well as complaint/demand for compensation from patients represented by lawyers, between 1 January 2000 and 31 December 2006. METHODS: All the reports of physicians associated with colonoscopy adverse events from health institutes covered by Madanes Insurance Group were analyzed and summarized using a specially designed questionnaire. Clinical and epidemiological details about the patients, procedures, and adverse events were coded into an excel sheet, discussed, and evaluated. RESULTS: One hundred and two cases of colonoscopy adverse events were reported. There were 48 cases of men (47.1%) and the average age was 69.9±12.90 years. In this period of time 252 064 colonoscopies were performed by the institutes in the sampling frame, and the number of adverse events was on average 4.0 (between 2.8 and 6.2) for 10 000 colonoscopies. The difference between the years was not statistically significant. Perforation occurred in one of 2864 procedures, bleeding in one of 29 007 procedures, and respiratory complications in one of 50 412 procedures. CONCLUSION: This is the first study in Israel based on physicians' reports of colonoscopic adverse events. The picture is optimistic, as the rate of complications is low, and the data encourage early detection and reporting.

Hormone concentrations in tobacco roots change during arbuscular mycorrhizal colonization with Glomus intraradices.

• Phytohormones are known to play a pivotal role in various developmental processes in plants and in arbuscular-mycorrhizal (AM) fungal-host symbiosis. This study focuses on characterizing the changes in the concentrations of auxins, cytokinins and gibberellins in tobacco (Nicotiana tabacum) during the early stages of colonization by Glomus intraradices, using advanced analytical detection techniques. • High-pressure liquid chromatography analysis followed by radioimmunoassay detection revealed that AM colonization induced the accumulation of specific zeatin riboside-like and isopentenyl adenosine-like compounds in both roots and shoots. • Use of the gas chromatography-mass spectrometry technique on the same developmental stage revealed that gibberellins (GA) of the earl-13-hydroxylation biosynthetic pathway (GA1 , GA8 , GA19 and GA20 ) were significantly more abundant in roots, but not shoots, of AM inoculated plants than in those of nonmycorrhizal plants. Indoleacetic acid concentrations (total and free) remained unaltered by AM colonization. • This study demonstrates that hormonal changes do occur during AM symbiosis with tobacco, before the fungal benefits manifest.