תוצאת חיפוש

Information Provided for Informed Consent in Clinical Trials

Avishay Sella

Genitourinary Medical Oncology Unit, Dept. of Oncology, Rabin Medical Center (Beilinson Campus), Petah Tikva, and Sackler Faculty of Medicine, Tel Aviv University

The Helsinki Declaration contains recommendations guiding physicians who conduct clinical trials. One is that the requirement for informed consent is essential for approval of a trial. An important component of the informed consent doctrine is that all data required for the participant's decision must be provided. We analyze data of a therapeutic trial, and define 12 data components outlined in, or directly derived from the Helsinki Declaration.

61 instances of informed consent for therapeutic clinical trials from various fields of medicine, from 1994 to 1997, were analyzed. In each the presence of the 12 components was evaluated.

The data demonstrated that there were only 5 components cited in most cases of informed consent: trial objectives, methods, treatment plan, risks, and the option of withdrawing. Benefit to the participant was mentioned in half the cases, while only limited information was provided about other components such as life-threatening and unpredictable risks, and alternative treatment.

Examples of informed consent from 1997 showed statistical improvement since 1994 in the data concerning trial objectives, methods, risks and alternative therapy. Informed consent documents of international multicenter trials compared with local trials showed statistical improvement in the data components of the trial objectives, methods, and risks, including those of potentially life-threatening and unpredictable risks, and alternative therapy. Analysis of informed consent showed that not all components required for a comprehensive decision regarding participation in a clinical trial are included. These data emphasize the need to design a structured informed consent protocol in which all the required data components are specifically outlined for potential participants.

Intrahospital Transport of Critically Ill Children

Gideon Paret, Ron Ben Abraham, Oshrat Yativ, Amir Vardi, Zohar Barzilay

Dept. of Pediatric Intensive Care and of Anesthesiology, Sheba Medical Center, Tel Hashomer and University of Tel Aviv

Prospective evaluation of intrahospittransportation of 33 critically ill children to and from the pediatric intensive care unit was conducted over the course of a month. Factors contributing to risk of transport were assessed.

There were 33 children (25 boys and 8 girls), 3 days to 15 years of age. Reasons for admission included: disease and trauma in 19, and status post operation in 11. The pretransport PRISM score was 4.84. 22 children (66.6%) were being mechanically ventilated and 10 (30.3%) were being treated with amines. Transport time ranged from 8-150 minutes. 15 of the transports (45.4%) were urgent and a special intensive care team escorted 22 (66.6%). Equipment mishaps and physiolog-ical deterioration occured in 12 (36.3%) and 11 (30.3%) of the cases, respectively. The use of amines, mechanical ventilation, longer transport time and high PRISM score were all associated with physiological deterioration on transport.

Treatment of Retroperitoneal Sarcoma

Dina Lev-Chelouche, Subhi Abu-Abeid, Mordechai Gutman, Yoram Kluger, Moshe Michovitch, Isaac Meller, Moshe Inbar, Joseph M. Klausner

Depts. of Surgery B, Orthopedic Oncology and Oncology, Tel Aviv - Sourasky Medical Center (Affiliated with Sackler Faculty of Medicine, Tel Aviv University)

Soft tissue sarcomas are exceedingly rare, making up less than 1% of all solid malignancies. In the retroperitoneum, they tend to be large when diagnosed and are a therapeutic challenge to the surgical oncologist. Our experience with 51 patients with retroperitoneal sarcomas operated on during the past 4 years is presented. 37 were primary and 26 presented as recurrent tumors. The group included many different histological sub-types, the majority being high grade tumors.

Complete resection was achieved in 84%, necessitating extensive surgery, but was not possible in 8 patients (16%) who underwent partial resection or biopsy only. There was 1 perioperative fatality (2%). 18 (35%) suffered complications, all of which were reversible. The estimated 5-year survival in the complete resection group is 40%, while none of those who underwent partial resection survived more than 2 years. There was significantly better survival in patients with primary, low grade sarcomas which were smaller than 8 cm, compared to those with high-grade, recurrent sarcomas larger than 8 cm. Local recurrence developed in 8 patients of the complete resection group (18%), 2 months to 3 years after surgery.

These data show that despite the concept of retroperitoneal sarcomas as being aggressive, invasive tumors with a poor prognosis, the prognosis is not unusually bad. With proper surgical technique, resectability may be high, with improved overall survival.

CT-Guided Excision of Osteoid Osteoma

A. Peyser, S. Porat, T. Sasson, J. Apelbaum, J. Bar-Ziv, E. Sucher

Orthopedic Surgery and Radiology Depts., Hadassah University Hospital, Ein Kerem, Jerusalem

CT-guided excision of osteoid osteoma is a new surgical technique that enables accurate resection of the nidus during 1-day hospitalization. We present 5-year results in 42 patients (26 males and 16 females, mean age 18 years, range 3-46). In 40 out of 42, complaints disappeared immediately after the procedure. The recovery period was short and the return to normal activity was faster than in the open surgical approach. Complications were minimal and transient.

Reactive Increase in Blood Pressure on Immobilization, but not Hypertension, Prevents Pressure Ulcers

Vladimir Shats, Silvio Kozacov

Geriatric Dept., Rebecca Sieff Hospital, Safed

Of 135 geriatric patients immobilized for at least 2 days, 37 (27.4%) had pressure ulcers (PU). Those without PU were the control comparison group. Gender, length of immobilization, number of blood pressure determinations and proportion with hypertension were similar in those with and without PU. Those with PU were slightly older than those in the comparison group: 75.5±8.8 and 74.7±9.6 years, respectively (p>0.05).

Of 66 patients with acute ischemic stroke, reactive increase of systolic or diastolic blood pressure to 140/90 mm Hg or above following immobilization, was seen in 60.6% and 22.7% of patients, respectively, and there were PU in 12.1%. Of 17 with recurrent ischemic stroke, corresponding figures were: 41.2%, 23.5% (p>0.05), and 47.1% (p<0.01). In 7 patients with previous ischemic stroke corresponding figures were: 14.3% and 0% (p<0.01) and 100% (p<0.001). In 36 operated for fracture of the femur, corresponding figures were: 50%, 11.1% (p>0.05), and 27.8% (p>0.05). For 9 patients with severe infections, sepsis or pneumonia, the corresponding figures were: 22.2% and 0.0% (p>0.05), and 44.4% (p<0.04).

The proportion of patients with reactive increase in systolic blood pressure on immobilization was lower in the PU group than in the controls, 27% vs 59.2%, (p<0.001). The corresponding figures for reactive increase in diastolic blood pressure were similar, 8.1% and 20.4%, respectively (p>0.05).

The mean systolic blood pressure on immobilization was higher in the control than in the PU group, 145.4±21.7 and 130.8±14.9 mm Hg, respectively (p<0.001). The corresponding figures for the mean diastolic blood pressure were similar, 81.2±10.5 and 75.7±8.9 mm Hg, respectively (p<0.01). An increase in systolic blood pressure on immobilization reduced the risk of developing PU (p<0.05).

There was no significant statistical relation between diagnosis of hypertension and proportion of patients with PU (p>0.05). Of 67 patients with hypertension, in 23.9% and 74.6% of them there was no increase in systolic or diastolic blood pressure, respectively. Statistical difference between lack of diastolic or systolic response was very significant (p<0.001).

Reactive increase of blood pressure, but not hypertension, predicts reduced risk of PU on immobilization in the hospitalized elderly. Diminished reactive increase of blood pressure in response to stress of any kind may be a criterion of frailty and reduced physiological reserves. Efforts to reduce elevated blood pressure when a patient is immobilized appear irrational.

Nerve Palsies Following Prolonged Use of Limb Tourniquets

G. Volpin, R. Said, W. Simri, B. Grimberg, M. Daniel

Depts. of Orthopedic Surgery and Neurology, Western Galilee Hospital, Nahariya

Nerve paralysis following the use of tourniquets, regular or pneumatic, for limb surgery is rare. We describe a 19-year-old male soldier who had tourniquets applied for 3 1/4 hours to his arm and both legs due to penetrating injuries. As a result, he suffered palsy of the radial nerve and both common peroneal nerves. Nerve palsy in such cases has not been described in the literature. It is not clear whether the cause is direct mechanical pressure on the nerve, nerve ischemia, or a combination of both.

We recommend that tourniquets should not be used continuously for more than 2 hours. If evacuation of the injured is delayed, the medical team should consider loosening tourniquets for short intervals or changing for a pressure bandage. This is providing the patient's condition is stable and bleeding does not start again on release of the tourniquet.

Operative Laparoscopy in Pregnancy

Eylon Lachman, Abraham Schienfeld, R. Boldes, Samuel Levin, Michael Burstein, Michael Stark

Depts. of Obstetrics and Gynecology, Misgav Ladach Hospital, Jerusalem

The development of laparoscopic surgery in gynecology and general surgery has greatly advanced over the past decade, and recently has been successfully performed in pregnancy. In the English literature we found that of the 518 cases reported (mean age 32 years) the most common was for cholecystectomy (45%), followed by operations on the adnexae (34%), appendectomy (15%) and others (6%). To these we add 3 cases of cholecystectomy and 1 of an adnexal tumor. Of all the reported cases, 33% were performed in the 1st trimester, 56% in the 2nd and 11% in the 3rd.

This review demonstrates a definite trend to laparoscopy in pregnancy. It appears to be safe when performed by experienced surgeons, but further studies addressing safety of laparoscopic surgery during pregnancy are needed to reach definitive conclusions.

Alcoholic Delirium: Warning Signs and Diagnosis

Eliezer Witztum, Izhak Z. Ben-Zion, Vladimir Lerner

Community Mental Health Center; and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

Lately an increasing number of physicians are asked to diagnose and treat physical and mental disorders caused by alcohol abuse, a phenomena which had been quite rare in Israel until recently.

Early diagnosis and efficient treatment are essential for the management of alcohol-dependent patients. Primary care physicians and hospital personnel should be more alert to the growing numbers of alcohol abusers and to their appropriate diagnosis and treatment. This article describes and summarizes the symptoms of alcohol withdrawal in general, and alcoholic delirium in particular. Problems in diagnosis and treatment are illustrated by typical cases, pointing out early clinical warning signs and suggesting some treatment guidelines.

Maximal Age Reflects Ignoring the Health of the Oldest in General, Geriatric, and Gerontolo- Gical Studies

Vladimir Shats

Geriatric Dept., Rebecca Sieff Government Hospital, Safed

In publications relating to the health of the elderly there are 2 ways of presenting maximal ages, collective (for example: 70+ years) and individual maximal age (for example 70 years). While enabling assessment up to a certain age, data from subjects above the maximal age stated in the research will not be included. From the literature of the past 10 years, there were selected 764 disease parameters (PD) and 177 parameters of aging (PA). Among them 667 (70.9%) and 274 (29.1%) were parameters with collective and exact maximal ages, respectively.

The lack of reference by authors to ages above 70 to 79 (or 70+ to 79+) and 80 to 89 (or 80+ to 89+) was calculated from the medical literature, and estimated as significant, and for ages above 80 to 89 was estimated as minimally significant, in regard to their focus on health data in the elderly. In different groups of parameters, 24% to 32% of maximal ages indicated significant and 25% to 65% minimal lack of reference. Maximal ages of PA were higher than those of PD (p<0.001), so lack of reference to health of the elderly was more significant when PD were studied as compared to PA. Lack of reference was more significant in studies of hospitalized and ambulatory patients and people living within the community. Usually authors checked all the populations of people living in nursing homes, but the total number of parameters relating to the latter, was very small, only 5.1% of the total number of parameters, so the populations of nursing homes did not reach the attention of the researchers.

Collective maximal ages are more often used in geriatric journals, including the Journal of the American Geriatric Society, as opposed to general and gerontological journals, although this approach seems to be too sweeping in the assessment of health of the elderly.

Cocaine "Mules"

Ornit Yanai, Jehuda Hiss

L. Greenberg Institute of Forensic Medicine, Tel Aviv (Affiliated with the Sackler Faculty of Medicine, Tel Aviv University)

We present 2 cases of "body-packer" syndrome (BPS) in which the "mules" carrying the packages of narcotics arrived at Ben-Gurion Airport presented symptoms of acute cocaine intoxication due to the bursting of packages of narcotics they were transporting within their gastro-intestinal systems.

Acute cocaine overdose due to sudden massive release of the drug into the digestive system in BPS, may cause psychosis, convulsions and eventually death. Blood levels of cocaine between 0.25 and 5 mcg/ml are toxic and occasionally lethal. When a package bursts within the digestive tract of a smuggler or blocks the intestines, an immediate laparotomy is necessary to evacuate the "ovules" and the remains of the drug from stomach and intestines. Patients merely suspected of being body packers can be diagnosed by physical examination and by means of various imaging methods. They can be conservatively treated with fluids and mild laxatives and kept under close supervision until the remaining packages are naturally discharged.

Sudden onset of psychotic behavior in travelers from South America or other drug-producing countries should raise suspicion of body-packer syndrome. The relevant authorities should therefore be aware of the symptoms and consider their potentially dangerous outcome.

Influenza Surveillance through Sentinel Reporting Clinics

T. Shohat, N. Versano, A. Kiro, G. Golan, E. Mendelson, M. Weingarten

For the Influenza Surveillance Network: Israel Center for Disease Control, Israel National Laboratory for Influenza and Central Virology Laboratory; Netka Child Health Center and Dept. of Family Medicine, Rabin Medical Center, Beilinson Campus, Petah Tikva

In a joint effort of the Israel Center for Disease Control, the National Center for Influenza in the Central Virology Laboratory, together with a group of collaborating pediatricians and family physicians, a network for influenza surveillance was established in the winter of 1996-97. Nose and throat swabs were obtained from 571 patients with flu-like illness. 133 (23%) were positive for influenza virus. Both influenza A(H3N2) and B were isolated, predominantly influenza B during the beginning of the season. Both circulating strains were antigenically similar to those included in the vaccine for 1996-1997. Patients from whom influenza virus was isolated were significantly more likely to suffer from cough and myalgia in comparison with patients whose cultures were negative (p=0.02 and 0.003. respectively). Results of the first year of surveillance indicate that sentinel reporting clinics are useful for timely detection and identification of the viral strains circulating in the community, thus allowing prompt intervention in preventing the spread of influenza. Conclusions from the first year of the study were drawn and applied in the winter of 1997-1998.

Epidural Spinal Abscess

E. Tamir, Y. Mirovsky, N. Halperin

Orthopedics Dept., Assaf Harofeh Medical Center, Zerifin

A 42-year-old man was admitted for fever and severe low back pain radiating to both legs. On MRI, an epidural spinal abscess from S1 to D10 was seen. Treatment included laminectomy, drainage of the abscess and antibiotics. Recovery was complete without neurological damage. Increased awareness of this disease may lead to diagnosis and treatment.

Lymphoma of the Knee Joint Simulating Patellar Fracture

E. Lebel, M. Itzchaki

Orthopedics Dept., Shaare Zedek Medical Center, Jerusalem

Fracture of the patella is not uncommon after direct anterior knee trauma. However, there are other medical situations that resemble it radiologicaly. We present a patient mistakenly diagnosed as having a patellar fracture who had primary, solitary, malignant B-cell lymphoma of the knee space eroding the lower pole of the patella. We have found no reports of such a lesion in the literature. Another commbenign condition that might erode adjacent bone is chronic synovitis. Our patient was treated withchemo- and radiotherapy and the lesion fully regressed with no evidence of local or systemic recurrence 1.5 years after diagnosis.
 

Diarrheal Disease among Care-Givers at Children's Day- Care Centers 

S. Koton, D. Cohen, M.S. Green

Israel Center for Disease Control, Ministry of Health and Gertner Institute, Chaim Sheba Medical Center, Tel Hashomer; Medical Corps, Israel Defense Forces; Dept. of Epidemiology and Preventive Medicine; Sakler Faculty of Medicine, Tel Aviv University

Diarrheal disease tends to spread from infected children to their families. Due to the increased risk of exposure, children's caregivers in day-care centers may have a higher incidence of diarrhea, particularly when caring for very young children. We therefore examined the incidence of diarrhea and antibodies to Shigella among caregivers in day-care centers, according to age groups of children in their care (<18, 18-34, and >35 months) and in comparison with the general population. 2 studies with a retrospective cohort and seroepidemiological cross-sectional design were carried out. Questionnaires were completed by 401 caregivers in 36% of all WIZO day-care centers. As a measure of past exposure to Shigella, levels of S. sonnei and S. flexneri antibodies were examined in the blood of 110 caregivers (ELISA method).

There was a higher incidence of diarrhea among young children, increasing the potential exposure to diarrheal agents among their caregivers. Nevertheless, no statistically significant differences in diarrhea incidence were found among caregivers of the various age groups during the previous year (p=0.768) and during the previous month (p=0.319), nor in absenteeism due to diarrhea during the last month (p=0.761). Levels of Shigella antibodies were similar among caregivers in all 3 groups. Diarrheal incidence was higher among women in the population control group than among caregivers during the previous year (p=0.005) and month (p=0.067). No statistically significant differences in levels of S. sonnei and S. flexneri antibodies were found between caregivers and women in the control group.

There was no evidence that diarrhea is an occupational hazard for caregivers of young children. An explanation may be the development of protective immunity against common diarrheal agents due to recurrent exposure.
 

The Israel Teratogen Information Service: A 10-Year Report 

A. Ornoy, S. Shechtman, J. Arnon

Hebrew University - Hadassah Medical School and Israel Ministry of Health, Jerusalem

The Israel Teratogen Information Service (TIS) was established 10 years ago with the help of the Ministry of Health and the Hebrew University-Hadassah Medical School. During these 10 years we have had 20,631 calls. We describe the results of our experience in counseling.

There was a gradual increase in the number of calls, which in 1997 reached 4,447. Most calls (84.5%) were during pregnancy, while 12% were prior to pregnancy. In 75.7% the calls were due to drug exposure during pregnancy; 10.9% were due to exposure to X-rays; there was maternal infection in 6.6% and in 5% immunization during pregnancy. The callers were: physicians in 46.6%, nurses 18.9%, pregnant women 39.5%, and 4.8% others.

In 76.6% there was no additional risk to the embryo or fetus and in 17.4% there was a small additional risk of less than 1%; a significant additional risk to the fetus was expected in only 6%. In 3625 pregnant women with known outcome there were 8.9% spontaneous and 9.2% induced abortions. Of the 2968 live-born children, 2.3% were malformed, a rate similar to that among controls.

The information provided by the TIS alleviated the fears most pregnant women have, and reduced unnecessary terminations of pregnancy planned because of unjustified fear of the teratogenic effects of agents to which women were exposed. It reduced the number of children born with congenital anomalies, since pregnancies were interrupted whenever there was a high risk for congenital anomalies.