Clinical trials report card.
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Clinical Trials as Topic↗
Biomedical subjects
Joshua Shemer
Publications and source records attributed to Joshua Shemer.
Quality assessment in primary military clinics of the Israel Defense Forces Northern Command.
OBJECTIVE: To assess the quality of care provided in primary military clinics. METHODS: A standardized assessment tool was used, with medical record audits and tracers (minimal clinical criteria for proper care of common conditions), peer-review observations of medical encounters, assessments of organization and administration, and patient satisfaction and physicians' occupational stress questionnaires. RESULTS: Forty-three clinics and 113 physicians were assessed. Tracers were high for management of upper respiratory infections and low for low back pains and mental problems. The average encounter time was 9 minutes, and 25% of medical encounters resulted in referrals to specialists. Regular physicians performed better than reservists. Surgeons performed worst as primary health care providers. Female physicians did better than male physicians. The integration of new immigrant physicians was successful, and they expressed less occupational stress. Smaller clinics were better, with longer encounter times and better patient satisfaction scores. CONCLUSIONS: Quality assessment of primary health care is feasible in the military system, providing useful information for future improvement.
Female↗
Year 2006 update of the National List of Health Services--an endless process.
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Biomedical Technology↗
[Generic drug substitution].
The rapidly rising health care expenditures, attributed mainly to the high cost of prescription drugs, have led governments around the world to look to generics as a means of containing costs in the pharmaceutical market. Generic drugs provide a less expensive alternative to brand name drugs due to the elimination of the need to perform lengthy and costly clinical trials, as required for innovative drugs. Essentially, generic substitution of drugs may be performed only after showing unequivocally that the generic formulation is identical in its active ingredients, strength, and route of administration as its innovative counterpart, and that they are bioequivalent to each other. Although the two are in essence the same, generic substitution is occasionally a controversial matter.
Costs and Cost Analysis↗
Is disease management "ready" for Israel?
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Chronic Disease↗
The use of medical informatics as a management tool for community health services during the 2006 Israel-Lebanon War.
BACKGROUND: During war the health management organizations have tremendous difficulty monitoring members' needs according to geographic spread. OBJECTIVES: To describe how an HMO used its health information technology in a way that enables its management to receive updated online information on the needs of the insured, according to their distribution throughout the country during the time of the war in Lebanon in July-August 2006. METHODS: Data were derived from the computerized medical records of Maccabi Healthcare Services--the second largest HMO in Israel, providing care to more than 1.7 million members nationwide. Data on healthcare utilization by northern members were compared to the geographic distribution of clinics. RESULTS: The war was characterized by the massive evacuation of citizens southwards. During this period there was an abrupt decline in the utilization of medical services by northern members in the northern region. This decline returned to normal 10 days after the ceasefire. A reciprocal increase was noted in the use of health services by citizens from the north in other regions. This increase returned to normal after the war. No such pattern was noticed during the same period in 2005. CONCLUSIONS: Real-time surveillance of trends in consumption of health services by citizens in times of regular daily living as well as during emergencies and wars is a vital management tool for medical directors responsible for providing health services.
Catchment Area, Health↗
The implementation of managed care for diabetes using medical informatics in a large Preferred Provider Organization.
BACKGROUND: It has been demonstrated by meta analysis that if a regular review of patients is guaranteed, the standard of primary care can be as good or better than hospital outpatient care, however, empirical data suggests that compliance with diabetes clinical practice recommendations is inadequate in primary care. This study describes the reorganization of diabetes care using disease management principles in a Preferred Provider Organization (PPO) operating on a country-wide basis in which each diabetes clinic became responsible for the overall care of all patients with diabetes. METHODS: This descriptive pre and post change study was undertaken in a large public-funded PPO insuring over one and half million individuals. The study was possible due the use of a centralized electronic disease registry which enabled the collection of all patient data. Several markers, such as HbA1C and LDC-cholesterol levels, were used to assess the quality of care for the diabetic patients. RESULTS: Mean HbA1C results of the cohort showed a continuous reduction from 8.1% (S.D. = 1.55) in 1999 to 7.68% (S.D. = 1.47) in 2002 and to 7.79 (S.D. = 1.54) in 2004. Improved results were also recorded for LDL-C 126.37 (S.D. = 35.16) in 1999 to 114.74 (S.D. = 34.49) in 2002, and to 113.39 (S.D. = 33.8) in 2004. The number of diabetic patients seen by the diabetologist increased by 62% over this period, despite an increase in diabetologist work hours of only 23%. CONCLUSION: The reorganization of health delivery for diabetic patients within a country-wide PPO, based on the principles of disease management and supported by medical informatics improves quality of care.
Cholesterol, LDL↗
Economic evaluation of medical technologies.
Innovation in medical science is progressing at a rapid pace. As a result, new medical technologies that offer to improve upon or completely replace existing alternatives are continually appearing. These technologies--which include pharmaceuticals, devices, equipment, supplies, medical and surgical procedures, and administrative and support systems--are changing the way medicine can be practiced and delivered, forcing healthcare providers and policymakers to consistently evaluate and adapt to new treatment options. Meanwhile, society is becoming more demanding of new medical technologies. Emerging medical technology, however, has been viewed as a significant factor in increasing the cost of healthcare. The abundance of new medical alternatives, combined with scarcity of resources, has led to priority setting, rationing and the need for more technology management and assessment. Economic evaluation of medical technologies is a system of analysis used to formally compare the costs and consequences of alternative healthcare interventions. EEMT can be used by many healthcare entities, including national policymakers, manufacturers, payers and providers, as a tool to aid in resource allocation decisions. This paper discusses the four current popular methodologies for EEMT (cost-minimization, cost-benefit, cost-effectiveness and cost-utility), and describes the industry environment that has shaped their development.
Cost-Benefit Analysis↗
[Tsunami--the death waves].
On December 26, 2004, the fourth strongest earthquake over the past century struck in the Indian Ocean off the western coast of northern Sumatra, Indonesia. Measuring 9.0 in magnitude, the earthquake triggered massive tsunamis that struck the Indian Ocean countries and Somalia, and killed more than tens of thousands and destroyed entire villages, leaving over a million homeless. Tsunamis are water waves that are caused by sudden vertical movement of a large area of the sea floor during an undersea earthquake. Tsunami speed can exceed 800 kilometers per hour, and as it reaches shallow water the height of the wave drastically increases. There are two natural warning signs of a possible tsunami: the earthquake itself and later, in the minutes preceding a tsunami strike, the sea often recedes temporarily from the coast. Despite these warning signs and despite a lag of up to several hours between the earthquake and the impact of the tsunamis, nearly all of the victims were taken completely by surprise. One of the most common myths associated with natural disasters is that dead bodies are responsible for the spread of epidemics. This article discusses the myths that often lead authorities and others to take inappropriate action, and presents valuable lessons to be learned from this catastrophic disaster.
Disasters↗
Medical technology management: bridging the gap between theory and practice.
New medical technologies that offer to improve upon or completely replace existing ones are continuously appearing. These technologies are forcing healthcare policymakers to consistently evaluate new treatment options. However, emerging medical technology has been viewed as a significant factor in increasing the cost of healthcare. The abundance of new medical alternatives, combined with scarcity of resources, has led to priority setting, rationing, and the need for further technology management and assessment. Economic evaluation of medical technologies is a system of analysis within the framework of health technology assessment to formally compare the costs and consequences of alternative healthcare interventions. EEMT can be used by many healthcare entities, including national policymakers, manufacturers, payers and providers, as a tool to aid in resource allocation decisions. In this paper we discuss the historical evolution and potential of EEMT, the practical limitations hindering more extensive implementation of these types of studies, current efforts at improvement, and the ethical issues influencing ongoing development. The Medical Technologies Administration in Israel's Ministry of Health is given as an example of an entity that has succeeded in practically implementing EEMT to optimize healthcare resource allocation.
Biomedical Technology↗
Reduced hospitalizations and death associated with influenza vaccination among patients with and without diabetes.
OBJECTIVE: To assess whether the influenza vaccination of community-dwelling, diabetic, elderly individuals is associated with reduced rates of hospitalization and death. RESEARCH DESIGN AND METHODS: In this outcome-research study, we compared mortality and hospitalization rates of 15,556 patients aged >or=65 years followed using a diabetes registry in a large health maintenance organization to that of 69,097 members not suffering from chronic disease who were considered as a reference group. The study outcomes included all-cause death and hospitalization in internal medicine or geriatric wards for any reason over winter and summer (control) periods. RESULTS: Vaccination rates were 48.8 and 42.0% among patients with diabetes and the reference population, respectively. Influenza vaccination was associated with a 12.3% reduction in hospitalization rates for patients with diabetes compared with 23.0% in the reference group (P = 0.08). The reduction in hospitalization rates was similar in both sexes among patients with diabetes. In addition, there was a significant reduction in mortality for the vaccinated group of patients with diabetes when compared with the nonvaccinated group except for female patients aged >or=85 years. CONCLUSIONS: The study results support the use of influenza vaccine among an elderly population. However, there does not appear to be an additional benefit for patients with diabetes.
Age Distribution↗
[Quality of community-based healthcare services].
The recent concern regarding the quality of healthcare services is partly due to the empowerment of health consumers, cost containment measures that may compromise quality, increased complexity of the medical practice and the accelerated growth of data on the magnitude and extent of quality problems. The framework of the delivery of health services, including quality parameters, differs fundamentally in the community as opposed to the hospital setting. In the community, the episode of care lacks geographic and temporal boundaries, and is divided among different facilities and caregivers. Hence, the healthcare systems lack control over the management of care. In the solo practice, the physician lacks the opportunity to discuss and share medical decisions with his/her peers and physician's reimbursement does not encourage him/her to invest time and effort in the provision of quality care. Furthermore, in the community setting, the patient is expected to take responsibility for compliance to the therapeutic regimen, a condition that may frequently interfere with regular life routines. Therefore, quality promotion should embody the "quality triangle" encompassing patients, caregivers, the healthcare system and appropriate interfaces. Ideally, the voice of the health consumer should be an integral consideration in the design of health policy, care should be patient-centered and physician reimbursement should reflect the quality of care provided. In addition, the design of the healthcare system information technology in supporting decision-making and training "quality leaders" to facilitate quality improvement programs. Consequently, it is pivotal to nurture agreement among policy-makers, patients and caregivers as to the essence of the dilemma: "What is quality in community care?" Meanwhile, we may suggest a primordial definition to community-based health care quality management: An ongoing multidisciplinary effort to identify and respond to the needs of patients, by providing systemic infrastructure that will support the caregivers and help in achieving better outcomes in the six basic dimensions of quality care-safe, timely, effective, efficient, equitable and patient-centered. In conclusion, in light of the medical activities conducted in the community, and the prevalent and ever-growing shortage of resources, there is a need to integrate efforts to develop and implement both unique tools and strategies to manage quality in community-based health services.
Community Health Services↗
[Clinical trials--historical development, regulation and updated data].
Medical research is a broad discipline in which clinical trials bridge between research and practice. During the 20th century, modern concerns regarding the ethical and clinical aspects of clinical trials led to the development of international standards and regulatory procedures that guide research in clinical trials. The rapid development of pharmaceuticals, biological products and medical devices facilitates an increase in the number and magnitude of the clinical trials that are performed worldwide. This overview surveys the historical and regulatory basics of clinical trials, and provides data on the extent and costs of clinical trials conducted throughout the past years, with a special emphasis on Israel.
Clinical Trials as Topic↗
[Traffic accidents--the national killer].
Traffic accidents are the most prevalent cause of death in developed countries between the ages of 1-33 years. In spite of a low motorization level in Israel, the rate of injury per 100,000 residents in Israel (2.8) was higher than in the US (1.8), NZ (1.7), Canada (1.7), Japan (1.3) and most European countries. The worst injuries were among pedestrians; particularly children aged 1-9 years and elderly (70+ years). In the past decade there have been significant advances in trauma care in Israel. Major strides included the foundation of trauma centers in hospitals, the establishment of the National Council for Trauma and the National Center for Trauma and Emergency Medicine Research at the Gertner Institute that coordinates the national trauma registry. One of the primary aims of the registry was to provide data to support decision-makers in setting national policy for accident prevention. The Israeli Police Department provides data on traffic accident victims to the Israeli Central Bureau of Statistics (CBS) which publishes the national figures. In their article in this edition of the journal, Dr Peleg and Dr. Aharonson-Daniel present a grave concern regarding the fact that details of over 50% of hospitalized traffic accident victims were not reported to the CBS by the police, including data on the severely injured casualties. Traffic accidents are a major cause of loss of life and disability, creating a heavy economic burden on the state and the health care system. Hence, the authors recommend establishing a national database which will combine data from medical and other sources and present the complete comprehensive picture of traffic accident injuries. Such a database will improve the decision-making process, providing more focused data to enhance the preparation and dissemination of appropriate injury prevention policies.
Accidents, Traffic↗
It is time to fortify basic foods in Israel according to the Canadian model.
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Canada↗
[Exclusivity of data in drug registration files and Israel's international status with regard to intellectual property rights protection].
Protecting intellectual property rights encourages creativity and innovation, which are key measures for research and development of new drugs and also promotes the introduction of drugs to new markets. Over the past years, many countries have enacted laws implementing the protection of data in drug registration files. Until recently, Israel has not provided any form of data protection. Current moves focus on new legislation granting exclusivity in the marketing of innovative drugs. Although controversial, this legislation aims to secure balance in Israel between the innovative pharmaceutical companies and the public's interest in competitive generic drugs.
Copyright↗
[Clinical trials--selected topics].
Clinical trials are a dynamic and complex research domain. Being the backbone of the clinical practice, clinical trials present a wide range of aspects. This overview deals with selected topics related to clinical trials, such as: factors influencing the choice of research issues, reasons for early termination of clinical trials, participating patients' access to experimental treatments following clinical trials, economic implications of clinical trials and the existence of publication bias in clinical research.
Clinical Trials as Topic↗
Health Value Added (HVA): linking strategy, performance, and measurement in healthcare organizations.
This paper describes "Health Value Added"--an innovative model that links performance measurement to strategy in health maintenance organizations. The HVA model was developed by Maccabi Healthcare Services, Israel's second largest HMO, with the aim of focusing all its activities on providing high quality care within budgetary and regulatory constraints. HVA draws upon theory and practice from strategic management and performance measurement in order to assess an HMO's ability to improve the health of its members. The model consists of four interrelated levels--mission, goals, systems, and resources--and builds on the existence of advanced computerized information systems that make comprehensive measurements available to decision makers in real time. HVA enables management to evaluate overall organizational performance as well as the performance of semi-autonomous units. In simple terms, the sophisticated use of performance measures can help healthcare organizations obtain more health for the same money.
Comprehensive Health Care↗