Long-term follow-up of patients treated with glatiramer acetate: a multicentre, multinational extension of the European/Canadian double-blind, placebo-controlled, MRI-monitored trial.

Glatiramer acetate (GA) is effective in reducing clinical and magnetic resonance imaging (MRI) activity in relapsing-remitting multiple sclerosis (RRMS). Serial long-term MRI data are lacking for large cohorts of GA-treated patients. The European/Canadian GA study consisted of two consecutive phases, each lasting nine months. The first treatment phase was randomized, double-blind and placebo-controlled. The second was an open-label, active treatment phase with daily administration of 20 mg GA subcutaneously for all patients. For the long-term follow-up (LTFU), dual echo, pre- and postgadolinium T1-weighted brain MRI scans were obtained with the same acquisition scheme as for the original trial and a neurological assessment was performed. Lesion volumes, normalized brain volumes and percentage brain volume changes (PBVC) were measured. One hundred and forty-two (63.4%) of the 224 patients who completed the two phases of the European/Canadian study underwent the LTFU after a mean period of 5.8 years (range: 5.3-6.4); 73 were treated with GA from study initiation. MRI measures at LTFU did not significantly differ between patients originally assigned to placebo and those who were always treated with GA, but the proportion of patients who did not require walking aids at LTFU was lower in the latter group (P=0.034). PBVC between baseline and LTFU was significantly correlated with lesion load at study entry. An earlier initiation of GA treatment in patients with active RRMS might, at least partially, have a favourable impact on long-term disease evolution.

Copaxone's effect on MRI-monitored disease in relapsing MS is reproducible and sustained.

All but 6% of the subjects with relapsing remitting MS who were randomly assigned to receive glatiramer acetate or placebo for the 9-month controlled phase of the European/Canadian MRI trial entered an open-label extension with quarterly clinical and MRI evaluations for another 9 months. There was a 54% reduction in the mean number of enhanced lesions for those converted from placebo to glatiramer acetate and an additional 24.6% reduction for those always on glatiramer acetate. Over the entire study the accumulated T2 disease burden was 34.2% less for those always on glatiramer acetate.

The gradient in mammography screening behavior: a lifestyle marker.

The study reports a gradient in adhering to a recommended health behavior-mammography screening. Data were collected on 951 Israeli women, aged 50-74, who were mailed an invitation to a prescheduled mammography screening appointment and were later phone interviewed about their background, their other health behaviors and their health perceptions related to cancer, mammography and self-rated health. The main finding that emerged was a gradient consisting of three groups defined by their adherence to mammography screening: women who declined the invitation to undergo screening (nonattenders, 32%), women who attended a screening upon encouragement (attenders, 45%) and women who initiated the test on their own (self-screenees, 23%). This gradient was shown to be related to structural/background variables (e.g. SES, age, education, ethnicity), other health behaviors and perceptual variables related to health in general and to cancer. For example, self-screenees were of a higher SES, engaged in more health behaviors and were closer to other women who performed a mammography. An analysis carried out to discern where the difference between the three groups lied showed that it was more apparent between the self-screenees and attenders, and that the attenders and nonattenders were more similar to each other. These findings are discussed in terms of health behavior as a discrete phenomenon vs. reflecting a lifestyle. Suggestions for intervention possibilities are presented in light of the finer ranking proposed above (as opposed to the dichotomy of engaging/not engaging in a health behavior).

Importance of diabetes mellitus and systemic hypertension rather than completeness of revascularization in determining long-term outcome after coronary balloon angioplasty (the LDCMC registry). Lady Davis Carmel Medical Center.

The study examined the 10-year outcome in a cohort of 227 unselected, consecutive patients (age 58+/-10 years) undergoing coronary balloon angioplasty between 1984 and 1986 and followed in a single cardiac center (Lady Davis Carmel Medical Center registry). In particular, we sought to identify the relative importance of the systemic risk factors diabetes and hypertension and the extent of coronary disease as opposed to procedure-related technical variables, the immediate success of the procedure, or completeness of revascularization. By life-table analysis (99% follow-up), 94% of the patients were alive at 5 years, and 77% at 10 years after angioplasty. Ten-year survival was reduced in patients with diabetes mellitus (59% vs 83%, p = 0.0008), in patients with previous myocardial infarction (68% vs 85%, p = 0.01), in patients with ejection fraction <50% (55% vs 82%, p = 0.005), and in patients with 3-vessel disease (58% vs 84% and 86% for 1- and 2-vessel disease, respectively, p = 0.04). Diabetes mellitus was the major independent predictor of poor survival (adjusted odds ratio 3.1, 95% confidence interval 1.55 to 6.19, p = 0.001). Survival at 10 years was identical in 199 patients in whom angioplasty was complete and in 25 in whom the balloon catheter did not cross the lesion, although bypass surgery was more frequent in the latter group (45% vs 21%, p = 0.001). Incomplete revascularization did not predict poor survival (72% vs 79% with complete angioplasty, p = NS). Event-free survival at 10 years for the whole group was 29%, and 49% of patients survived with no event other than a single repeat angioplasty procedure. Multivessel disease, hypertension, and diabetes mellitus were independent predictors of decreased event-free survival, but incomplete revascularization was not. Thus, long-term outcome after coronary balloon angioplasty was related to diabetes mellitus, systemic hypertension, and extent of coronary disease, but not to the immediate success of the procedure or completeness of revascularization.

A 12 versus 6-week course of bacillus Calmette-Guerin prophylaxis for the treatment of high risk superficial bladder cancer.

PURPOSE: We examined the efficacy of a 12-week prophylactic course of bacillus Calmette-Guerin (BCG) on superficial bladder cancer. MATERIALS AND METHODS: From August 1992 until July 1994, 70 evaluable patients 41 to 80 years old (mean age 68.5) with high risk transitional cell carcinoma of the bladder were prospectively randomized to a 12-week prophylactic course of BCG (group 2) versus a traditional 6-week course (group 1). Mean followup was 28 months. RESULTS: A 70% tumor-free rate (21 patients) and mean interval of 12.9 months to recurrence were achieved in group 2 compared to 55% (22 patients) and 12.3 months, respectively, in group 1. Group 2 patients had an overall longer disease-free survival, although no statistical significance was achieved. A subgroup of patients with stage Ta cancer in whom at least 1 tumor was resected 12 month before treatment showed the most benefit from long-term prophylactic treatment in terms of disease-free survival. Side effects were only slightly more prominent in group 2, rendering the longer course fairly acceptable. CONCLUSIONS: Our findings suggest a difference for better overall results with the 12-week course of BCG. However, a larger number of patients are needed to demonstrate a statistically significant difference between the 2 groups.

Compliance with mammography screening in Israeli women: the impact of a pre-scheduled appointment and of the letter-style.

The objectives of this study were to determine the impact of different personal invitations on screening mammography attendance and to clarify the influence of personal characteristics and health-related attitudes and behaviors on compliance. One thousand and five hundred women, aged 50-74 years, were randomly selected in the city of Haifa. Four letters of invitation were used. Actual mammography performance was validated by a national computerized database. All other data was collected via a telephone interview following the mammography. The overall compliance rate amounted to 45%. The major predictors of compliance were having had a clinical breast examination within the previous year (p = 0.0008), having a health professional recommend routine mammography (p = 0.01) and perceiving mammography as efficient in early detection of breast cancer (p = 0.02). Aggressiveness of message details, or a family physician's or higher authority's signature on the letter had no impact on compliance. A letter of invitation for a routine mammogram at a specific time resulted in an overall rate of compliance 3-fold higher than the baseline. Based on the results of this study. Kupat Holim Clalit decided to implement use of personal invitations for screening mammography to israeli women on a regular basis.

Psychosocial and medical factors in pregnancy outcomes: a case study of Israeli women.

Building on a body of research which confirms that psychosocial factors have an important influence on health in general and on pregnancy outcomes in particular, we carried out a prospective study of pregnant women in Israel. We hypothesized that medical pregnancy and delivery outcomes are mediated by psychosocial coping resources and risks. Resources were defined as social ties, and risks as life events self-reported as stressful. The population studied included 233 women who responded to questionnaires after the second trimester of pregnancy. Medical data on the delivery were collected from hospital archives. The questionnaire measured biomedical risks, including general medical and obstetrical history, as well as health behaviours, social ties, and perceived stress. Pregnancy outcomes were classified according to medical measures of abnormalities in mother and child at birth. Our findings show that resources such as the variety of social ties (family, friends, neighbours and colleagues) interacted significantly with biomedical risk. It was found that low scores for social ties anticipated 3.6 times higher negative medical outcome in otherwise healthy women than in those with higher scores for social ties. The findings of the study are discussed in terms of their implications for relating to social competence as a determining element in health and health behaviour.

The yield of bone scintigraphy in cancer and non-cancer patients: its association with indication and clarity of the referral question.

The yield of bone scintigraphy was assessed in a general hospital. A random 1:2 sample of the bone studies performed within a year was evaluated. The referral forms were judged to show absent, ambiguous or clear diagnostic questions. The indications for which the study was ordered were matched with the scintigraphic diagnosis, and yield was defined as the proportion of studies with relevant findings on scintigraphy. The overall yield was 23.5%. In cancer patients the yield was 27.2% and in repeat studies 40.2%. In non-cancer patients the yield was 19.8% and when scintigraphy was performed for the evaluation of specific disease entities it was 35.7%. Relatively low-yield indications in non-cancer patients were suspected metastases 11.1%, and evaluation of X-ray abnormalities 11.5%. An association between the clarity of the diagnostic question and the scintigraphic yield was detected in non-cancer patients. When a diagnostic question was absent the yield was 12%, ambiguous 19%, and when it was clear 26%. This correlation is probably attributed to better understanding of this common procedure, and better definition of the diagnostic question in patients with diverse clinical conditions as compared to cancer patients in whom the question always relates to the presence of bone metastases.

The care of family physicians and their families: a study of health and help-seeking behaviour.

Physicians in general are at risk for the development of stress, drug and alcohol abuse, as well as for suicide. Furthermore, the treatment of the sick physician is more difficult than that of a 'regular' patient. These difficulties may cause the postponement of diagnosis and treatment to critical stages of the disease. This paper presents a study of self-rated health and health-seeking behaviour of Israeli family physicians and their families. Our major finding is that two-thirds of the physicians do not have a regular family physician, and physicians who suffer from chronic diseases are even less likely to be treated than the 'healthy' ones. Twenty eight per cent of the physicians did not use any kind of medical consultation. However, each physician's family did receive some form of medical consultation, although in some cases this was not the usual form of medical care. The physicians who treated themselves tended to treat their own families and vice versa. Eighty-eight per cent of the physicians reported stress owing to their work (work overload, poor relationships with the medical team or with the patients), and 20% said that their work as physicians negatively affected their marital life. The relationship between the help-seeking behaviour of the family physician and the quality of care they give is as yet unclear. Various alternatives are raised for changing family physicians' behaviour as well as the primary care health system in order to possibly provide better care for the physicians and their families.