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A new procedure for group sequential analysis in clinical trials.

Since Pocock (1977, Biometrika 64, 191-199), many methods have been developed for group sequential analysis of clinical trials. However, these methods remain underemployed partly because of inconsistencies of sequential testing [Berry (1987, The Statistician 36, 181-189)]. This paper considers a new approach, which, by requiring that a succession of interim analyses be significant at the alpha level, both preserves the overall significance level alpha and does not present some of the inconsistencies of the previous methods. Results are obtained for a normal or binary response and for survival data. A comparison with the usual group sequential testing is also presented.

Analysis of Variance↗

Hispanic health in the United States. Council on Scientific Affairs.

Hispanics are the fastest growing minority in the United States. Typically, they are divided into five subgroups: Mexican American, Puerto Rican, Cuban American, Central or South American, and "other" Hispanics. Risk factors for morbidity and mortality vary among these subgroups. Use of health care services is affected by perceived health care needs, insurance status, income, culture, and language. Compared with whites, Hispanics are more likely to live in poverty, be unemployed or underemployed, and have little education and no private insurance. Hispanics are at an increased risk for certain medical conditions, including diabetes, hypertension, tuberculosis, human immunodeficiency virus infection, alcoholism, cirrhosis, specific cancers, and violent deaths. Proportionate to their representation in the population, there are few Hispanic health providers, emphasizing the need for all medical personnel to be knowledgeable about Hispanic health care needs.

Adult↗

Hypertension in blacks: clinical overview.

Although the decline in stroke and other cardiovascular morbid and mortal events has been occurring since the 1940s, the steeper decline since 1968 has been attributed to improved hypertension awareness, treatment, and control. However, in spite of this encouraging trend from the population in general, surveys from the 1970s and our more recent survey from the Maryland Hypertension Program indicate that hypertension control among blacks remains unacceptably poor, particularly in view of the high prevalence. Of special concern are black men, who have the highest prevalence of any group and the poorest control rate (see Tables 6-1 through 6-4). According to Gillum and Gillum, "High rates of non-compliance with follow-up and drug therapy seriously compromised the efforts of community-wide programs. Indeed, non-compliance with therapeutic or preventive health advice is now the major barrier to effective hypertension control in the United States." Impediments to ideal hypertension control in black communities can be divided into three categories 1. Severity of hypertension in blacks. 2. Barriers related to the medical care system, including inadequate financial resources (see also Chapter 5), inconveniently located health care facilities, long waiting times, and inaccessibility to health education, specifically as it relates to hypertension. 3. Barriers related to the social, psychosocial, and sociopolitical environment, which include problems of underemployment, unemployment, racism, and strained racial relationships. In summary, one could say that, in spite of generally improved hypertension control in the United States, the group that has the worse problems (blacks, especially males) is not benefiting as much as the general population. The strategy for treating black patients with hypertension is little different from that applied to all other patients. However, consideration must be given to the patients' lifestyle. The cultural differences in diet especially must be taken into account. Finally, economic considerations must always be an important component in managing black hypertensive patients. For a detailed discussion of treatment alternatives, see Chapter 11.

Adolescent↗

Myths, maxims and universal health care.

There is considerable indirect evidence that our legislative bodies, because of inability to control costs, are reluctant to further expand government responsibilities into health care. There continues to be general societal, and limited professional, pressure to assure access to health care for the large segment of society which presently encounters barriers to care because of lack of insurance. Congress and state legislatures are actively proposing health care legislation but on the whole it is aimed at reducing the cost of the programs to which government is already committed, not for expansion into new fields. However, providers, physicians and hospitals are begging for relief from the burden of uncompensated care. A suggested solution is to require all employers to provide health insurance for their employees. This may become impossibly burdensome for many small employers and could still leave a sizeable uninsured group of unemployed or underemployed. Tax revenues would still be needed to fund a government administered program to assure their access. We have a problem. We must devise a method to assure needed care for the 13% to 15% of our population which is presently uninsured. It must be accomplished in a manner that will not direct too much money from other socially important programs such as education, law enforcement, transportation, and environmental preservation. A solution will be found; however, if my evaluation is correct, neither patients nor physicians are going to be very happy with it. If the myths and maxims are valid, both groups will be disappointed. Rationing in some form will be inevitable as will be control and regulation of doctors' practice styles and fees.(ABSTRACT TRUNCATED AT 250 WORDS)

Health Expenditures↗

Rural nurses. Part II, Surviving the nurse shortage.

Cost containment and the nurse shortage have impacted rural hospitals and their nursing staffs. This impact did not appreciably affect burnout levels among the rural nurses, but did evidence itself in the reports of the directors of nursing and their nurses. Cost containment brought with it layoffs of colleagues in the work setting who were neighbors or relatives. This occurred while the rural areas were already filled with the unemployed and underemployed. Unfamiliar recordkeeping increased two- and three-fold, and the 23-hour admit caused unequal work flow. Downsizing, elimination of some services and reports of rural hospital closings were threatening to the nurses, who were often the sole support of their families. The rural nurse shortage was seen to be different from the national nurse shortage in significant ways. Except for the few study hospitals that were close to population centers, nurses could not be recruited from outside the geographic area. Suggestions from the Secretary's Commission on Nursing are not all appropriate for the rural hospital nurse shortage. Rural hospitals changed in the face of cost containment, and nursing personnel also worked to contain costs. However the nurses have worked within cost and salary constraints for so long that they predict loyalty to their community hospitals can be coming to an end. The nurse shortage is being approached by minor alterations in staffing and mode of care delivery. Federal support is desperately needed by the rural hospitals to permit equitable salaries, and to support financial aid to permanent residents of the rural areas for entrance into or advancement in nursing education.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

[Use of radionuclide isotopes by cardiologists. Results of a French survey. Study group: "Nuclear Cardiology" of the French Society of Cardiology and the Society of Nuclear Medicine and Biophysics].

The authors report the results of an enquiry carried out amongst French cardiologists to determine their opinion about radionuclide investigations in cardiological practice. Of the 5,050 cardiologists contacted, 1,431 (28.3%) replied. The cardiologists were attracted by the non-invasive nature (84%) of radionuclide techniques and their complementarity with other methods of investigation (74%) but regretted their cost (55%), their lick of availability in emergencies (35%) and, in general, their difficult of access (30%). Only 38% of the cardiologists who replied used radionuclide investigation on an everyday basis, this being impossible for some because of the distance to the nearest centre with these facilities (on average 32 km but exceeding 50 km in 29% of cases, and the delay before obtaining an appointment (average 13 days) which was often excessive, especially for myocardial scintigraphy (thallium or equivalent). Each cardiologist prescribed an average of 5 myocardial scintigraphies, 3 pulmonary scintigraphies and 2 radioisotopic ventriculography per month. These results seem to be an overestimation; in fact, radionuclide investigations are relatively underemployed, probably more because of the factors cited above than because of lack interest or quality, these latter two points being generally judged positively by the majority of cardiologists. Cardiologists require more from the conclusions of the investigation than a simple description of the images obtained. As with all other investigations that they perform themselves, the interpretation of the results must take the clinical context into consideration and form part of the diagnostic and therapeutic management of the patient.(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiology↗

[Physicians in Mexico, 1970-1990].

A study was carried out in 1970 on the distribution of medical personnel in Mexico. At that time an unequal distribution of physicians was detected, but not emphasized given the general shortage of physicians in the country. At the present time, the situation has changed. In this article the analysis of the 1990 census data using traditional indicators of availability of physicians in the country, as well as indirect criteria of physician requirements is presented. In the year of reference there were 157,407 physicians in the country, with a national average of 673 persons per physician. The distribution of physicians by state showed a great deal of variation in the number of persons per physician. For example, the state of Chiapas has 1,642 inhabitants per physician, whereas the Federal District has 292. The relation between trained and employed physicians shows another important phenomenon: there is a high percentage of physicians that do not practice clinical medicine (19.4%). Nevertheless, the number of physicians almost tripled the growth experienced by the general population, and important differences among and within states do persist. Furthermore, a new paradoxical effect has emerged, the presence of underemployment and unemployment of physicians, even in communities with greater needs for medical care. This indicates that the strategy of training more physicians has not solved the problems of accessibility and coverage, but in fact has fostered new problems and perhaps greater inequalities.

Demography↗

Temporal lobectomy for refractory epilepsy.

OBJECTIVE: To examine the long-term effectiveness of anterior temporal lobectomy for refractory epilepsy with regard to seizure control and related medical and psychosocial measures and to determine how patterns of early seizure recurrence relate to long-term prognosis. DESIGN: A cohort of patients prospectively followed up for 5 years after surgery. SETTING: Tertiary care comprehensive epilepsy center. PATIENTS: Eighty-nine patients with medically refractory epilepsy who were consecutively treated with anterior temporal lobectomy between 1986 and 1990. All patients had noninvasive preoperative evaluations, and 31 were evaluated with intracranial electrodes prior to surgery. MAIN OUTCOME MEASURES: Postoperative seizure frequency, neuropsychologic function, mortality, and postoperative employment status. RESULTS: Five years after surgery, 62 patients (70 percent) were seizure free, 8 (9 percent) had seizures on fewer than 3 days per year or exclusively had nocturnal seizures, 10 (11 percent) had greater than 80 percent reduction in seizure frequency, 5 (6 percent) had less than 80 percent reduction in seizure frequency, and 4 (4 percent) died of causes unrelated to surgery. The proportion of patients in each outcome class remained stable throughout the 5-year period. Fifty-five percent of seizure recurrences happened within 6 months of surgery, and 93 percent occurred within 2 years after surgery. Outcome at 1 year related only moderately well to outcome at 5 years. No significant cognitive or linguistic deficits occurred. All patients who died had persistent seizures after surgery. Underemployment and unemployment declined significantly after surgery, with improvement noted in seizure-free patients. CONCLUSIONS: Temporal lobectomy provides sustained seizure relief over 5 years to most patients who have surgery. Outcome at 2 years predicts long-term outcome. A seizure-free state is associated with reduced mortality and increased employment. Mere reduction in seizure frequency is not associated with improvement in those measures.

Adolescent↗

Eradication of communicative disorders: preventive medicine in the 21st century.

Profound changes in our society occurring over the past few decades have resulted in a major shift in societal emphasis from labor to communication. The widespread use of personal computers has enhanced the importance of information-communication in daily life. People with communication disorders are at substantial risk of underemployment and lowered quality of life. Advances in medical science and hearing health care have placed us on the thresholds of being able to correct, rather than remediate, certain types of hearing loss. The finding that auditory hair cells of submammalian species regenerate has stimulated greatly the field of auditory research. A new lexicon is required to describe this emerging field. Methods exist to protect against hearing loss, repair affected structures prior to their degeneration, promote dedifferentiation-redifferentiation of undamaged structures into sensory cells, and, finally, promote regeneration of new sensory cells from precursor cells. Each of these processes has unique requirements, and all may be required to promote the restoration of hearing following damage or disease.

Cochlea↗

Access and barriers to mammography in New England community health centers.

BACKGROUND: Historically, screening measures for poor patients have been underemployed. As a result, diagnosis of breast cancer is more likely made at later stages in underserved and minority populations. Regular care in community health centers (CHCs) can mitigate this screening inequity. The purpose of this study was to determine the barriers to and frequency of breast cancer screening in New England CHC women, and to compare our findings with the Healthy People 2000 goal of screening 60% of women aged 50 years and older with mammography every 2 years. METHODS: A consecutive series survey of 3176 women aged 40 years and older was performed between April 1 and August 31, 1995, at 32 CHCs in six states. RESULTS: Completed questionnaires were returned on 2943 patients, including 200 African-American, 2222 white, 370 Hispanic, and 56 Asian women; 932 (32%) were aged 40 to 49 years, and 2011 (68%) were aged 50 and older. Within the preceding 2 years, 2072 (70%) had had a breast examination by a provider. Eighty-seven percent reported that mammography was recommended. More women aged 50 years and older (55%) had had mammography during the last 2 years than women in the 40- to 49-year-old group (45%) (P < .004). The most common reason for not having a mammogram was that the patient thought "the test was not important"; expense and lack of insurance was second. Hispanics had the lowest rates of mammography. CONCLUSIONS: Progress is being made toward Healthy People 2000 goals in New England CHC women. Despite low income status, 55% of women aged > or = 50 years had had mammograms within the past 2 years. Once cost is removed as the greatest barrier, improving patient acceptance promises the largest increase in the use of mammography screening.

Adult↗

[New problems of adolescents: perspectives for the intervention of the pediatrician].

The Pediatrician is daily in contact with a large number of adolescents, and therefore is able to recognize those who display behavioural problems. The Pediatrician is often asked for advice in order to solve practical problems such as the choice of school, the practice of sports, ecc. His advice is somehow conditioned by his previous experiences as an adolescent and, if he is a parent himself, by his present familial situation. In the last years, the problems of the adolescents and the fears of their parents have changed, the main concern being today the one for work, due to the high levels of unemployment and underemployment affecting our society. In this situation, some of the most frequent attitudes of parents towards adolescents seem to be erroneous, such as asking them for social success at any cost (e.g. attending unwelcome studies or performing inappropriate sports). This leads to failures that often prove to be unbearable for young people not trained to face and overcome frustration. Parents also seem often to underestimate the possibility of their own "child" being involved in episodes of hooliganism, shoplifting, violence like the ones daily described by the media. The excessive idealization of adolescents by their parents seems to be one of the main causes of this situation. The Pediatrician can intervene with advice, in order to orientate adolescents towards realistic life objectives and a satisfactory development of their personality.

Adolescent↗