Research participants' opinions of delayed consent for a randomised controlled trial of glucose control in intensive care.

PURPOSE: Critically ill patients are often unable to give informed consent to participate in clinical research. A process of delayed consent, enrolling patients into clinical trials and obtaining consent as soon as practical from either the participant or their substitute decision maker, has sometimes been used. The objective of this study was to determine the opinion of participants, previously enrolled in the NICE-SUGAR study, of the delayed consent process. METHODS: This observational study was conducted from 2009 to 2010 in the ICU of a tertiary referral hospital in Australia. Participants who were enrolled in the NICE-SUGAR study with delayed consent who survived, were cognitively intact, and proficient in English were posted a questionnaire regarding their opinion of the delayed consent process. The questionnaire was returned by post, fax, email, or completed during a telephone interview. RESULTS: Of 298 eligible participants, 210 responded, with an overall response rate of 79 %. Delayed consent to participate in the NICE-SUGAR study was obtained from participants (57/210; 27.1 %) or the substitute decision maker (152/210; 72.4 %). Most respondents (195/204; 95.6 %) would have consented to participate in the NICE-SUGAR study if asked before enrolment; most (163/198; 82.3 %) ranked first "the person who consented on their behalf for the NICE Study" as most preferred to make decisions, should they be unable; and most (177/202; 87.6 %) agreed with the decision made by their relative. CONCLUSION: Delayed consent to participate in a clinical trial that includes critically ill patients is acceptable from research participant's perspectives.

Unwanted caesarean sections among public and private patients in Brazil: prospective study.

OBJECTIVE: To assess and compare the preferences of pregnant women in the public and private sector regarding delivery in Brazil. DESIGN: Face to face structured interviews with women who were interviewed early in pregnancy, about one month before the due date, and about one month post partum. SETTING: Four cities in Brazil. PARTICIPANTS: 1612 pregnant women: 1093 public patients and 519 private patients. MAIN OUTCOME MEASURES: Rates of delivery by caesarean section in public and private institutions; women's preferences for delivery; timing of decision to perform caesarean section. RESULTS: 1136 women completed all three interviews; 476 women were lost to follow up (376 public patients and 100 private patients). Despite large differences in the rates of caesarean section in the two sectors (222/717 (31%) among public patients and 302/419 (72%) among private patients) there were no significant differences in preferences between the two groups. In both antenatal interviews, 70-80% in both sectors said they would prefer to deliver vaginally. In a large proportion of cases (237/502) caesarean delivery was decided on before admission: 48/207 (23%) in women in the public sector and 189/295 (64%) in women in the private sector. CONCLUSIONS: The large difference in the rates of caesarean sections in women in the public and private sectors is due to more unwanted caesarean sections among private patients rather than to a difference in preferences for delivery. High or rising rates of caesarean sections do not necessarily reflect demand for surgical delivery.

Classifying complications of interventional procedures: a survey of practicing radiologists.

PURPOSE: To determine the variability of radiologists' classification of complications from interventional procedures. MATERIALS AND METHODS: Fifteen test cases were selected from a database of morbidity and mortality cases that occurred in our department during the past 2 years. Ten cases were selected randomly, and five were chosen because of classification difficulties within our department. A survey with the case descriptions was presented to 145 SCVIR members via the World Wide Web and 48 were distributed to participants at a statewide angiography club meeting. Participants were asked to complete a short assessment of the their clinical background and to classify each case as "no complication," "minor complication," or "major complication." RESULTS: Thirty-eight percent (74 of 193) of the surveys were completed. Seventy percent (52 of 74) of the respondents were affiliated with an academic program, 12% (nine of 74) were affiliated with private practice groups, and 18% (13 of 74) claimed both academic and private affiliation. The consensus rate in classifying the complications for the randomly selected cases varied from 50% to 95%, with a median of 69%, and the consensus rate in classifying the selected cases varied from 46% to 95%, with a median of 85%. The lowest consensus rates occurred when (i) a significant procedural event was followed by a normal outcome, (ii) when a procedure was aborted, and (iii) when a significant event occurred but did not prolong hospital stay. CONCLUSION: Current criteria for reporting complications are associated with moderate rates of disagreement among interventional radiologists.

Integrating mental health services into primary care for HIV-infected pregnant and non-pregnant women: Whole Life--a theoretically derived model for clinical care and outcomes assessment.

Poor women of color who are disproportionately both infected and affected by HIV/AIDS also face multiple lifestyle and psychosocial burdens that complicate effective delivery of health care, thereby contributing to their poorer prognosis. Addressing these factors within the context of HIV/AIDS primary care for women is the aim of Whole Life, a program to integrate mental health services into primary care for HIV-infected pregnant and non-pregnant women. Whole Life utilizes a theoretically derived clinical services model that provides data for both clinical care and patient outcomes research within the constraints of a clinical setting. During a woman's first two clinic visits, data are gathered in structured interviews with standardized instruments-adapted for relevance to the population-that meet clinical and service needs, as well as measure components of the Whole Life model. Interviews are conducted by existing front-line staff who have been trained in using these instruments to gather information typically recorded in clinical notes. The implementation of Whole Life to date clearly demonstrates the feasibility of mental health-primary care services integration in a publicly funded HIV primary care clinic serving poor women of color.

History of gestational diabetes, insulin resistance and coronary risk.

The purpose of this study was to examine characteristics associated with the insulin metabolic syndrome, including insulin resistance, abnormal glucose tolerance, dyslipidemia, obesity, and elevated blood pressure, among women who have experienced gestational diabetes. 39 nondiabetic, young (20-42 years), postpartum (3-18 months) white women were recruited from obstetrical clinics. Twenty-one women had a history of gestational diabetes; 18 had uncomplicated pregnancies. Multivariate analyses revealed a significant difference between groups in insulin resistance (M, measured by euglycemic clamp) and insulin levels (from an oral glucose tolerance test), with insulin resistance showing a statistically stronger difference than insulin levels. Groups also differed significantly when compared on a set of variables associated with insulin metabolic syndrome: glucose tolerance, triglycerides, blood pressure, and body-mass index. Using insulin resistance as a covariate eliminated these group differences, suggesting that insulin resistance is the key factor underlying insulin metabolic syndrome. The higher risk of later developing type 2 diabetes and hypertension in women who have a history of gestational diabetes is explicable by their poorer profile on variables associated with insulin metabolic syndrome, and appears to be attributable to insulin resistance. Thus, insulin resistance appears to distinguish young women at risk for cardiovascular disease.

The use of personal computers in nuclear medicine.

Consolidating personal computers (PCs) with nuclear medicine technology can create high computational power comparable with that produced by vendor-specific computer equipment, and at more affordable prices. The integration of a standard platform and operating system with a large installed base has enabled our department to maintain itself at the cutting edge of technology with minimal expense. Along with the savings from the purchase of PC software and hardware come the added advantage of rapid training of staff with minimal in-house effort, especially given the vast educational support in the general community. The integration of a standard platform and operating system with a large installed base has provided the nuclear medicine department with computational resources once unheard of because of economies of scale. The acceptance and integration of a pervasive, flexible technology into nuclear medicine have shown that state-of-the-art studies can be performed at low cost.

Maternal health care utilization in Jordan: a study of patterns and determinants.

This article analyzes the patterns and determinants of maternal health care utilization in Jordan, using data from the Jordan Fertility and Family Health Survey of 1983. The study focuses on the 2,949 women who had a child in the five years preceding the survey. Through multivariate analyses of differentials in the utilization of prenatal care and health care at delivery, the study assesses the effect of sociodemographic factors, including residence, education, parity, and standard of living. The coverage of maternal health care in Jordan is discussed in relation to the overall organization of health services, the various providers of care, and the role of cultural factors.

PIP: Researchers used data from the 1983 Jordan Fertility and Family Health Survey to measure differentials of utilization of maternal and child health (MCH) services. 58.4% of the women had some prenatal care, 57.2% of these went to the private sector, mainly physicians (42.4%). The next leading provider of prenatal care was public MCH centers (25.2%). 48% began prenatal care in the 1st trimester and went 5 or more times (adequate care). 55% using the private sector for prenatal care had adequate care compared to 38% for the public sector. Even though most sought prenatal care in the private sector, 40.5% of the births took place in public health facilities vs. 18.3% for private hospitals. Professional midwives delivered most babies (42.5%) followed by physicians (32.1%) then traditional birth attendants (TBAs; 22.1%). TBAs attended 53% of home births then midwives (38%). 43% who delivered at a public hospital had prenatal care in the private sector, yet only about 20% who delivered in a private hospital received prenatal care in the public sector. 54% of those who had prenatal care in the private sector delivered at home. 54.3% who went to a private hospital had adequate care compared to 28.8% in a public hospital and 14.6% who had their child at home. Living in an urban area, high standard of living, and high education significantly and positively affected the intensity of utilization of prenatal care and the timeliness of this care (p.001). On the other hand, women who had at most limited prenatal care were more likely to have many children and live in a rural area (p.001). Most significant predictors of prenatal care and using a private hospital were a high standard of living, if the woman lived in an urban or rural area outside Amman, and more space/individual, if the household had a high standard of living. Public health facilities in Jordan were underutilized.

[Health care personnel's opinion on the breast-feeding pattern in the Mexican rural area]. / Opinión del personal de salud sobre el patrón de lactancia en el área rural de México.

This paper surveys the health care personnel's knowledge and opinion about the physiology of the mother milk production and the issues that occur when it is stopped at an earlier moment. From an inquire carried out in 1984 on 155 doctors and nurses and 48 midwives that render their services to the rural population of Mexico, it was found that the majority of the health care personnel recognized breast-feeding as the best nurture for the child. Nevertheless, this personnel is against having a long breast-feeding period. More than half of the doctors and nurses commented that the breast-feeding period must be stopped when the child has diarrhea, which is contrary to the international health agencies opinion. The majority of the health care personnel recommends the introduction of complementary food to children under three months old and suggests a quick stop of the breast-feeding period. From these data it is shown that the health care personnel has little knowledge about the breast-feeding role as an element that increases the period of amenorrhea and its value as a natural contraceptive. The relation between breast-feeding and amenorrhea and infertility is inaccurate, that is why it is concluded that it is necessary to have training for the health care personnel in some physiological aspects of breast-feeding that are of prime importance. If the health care personnel has a better knowledge about breast-feeding, these influencing agents to decrease the incidence and value of breast-feeding will turn into strong promoters of such a healthy practice.

Atheromatous pseudo-occlusion of the internal carotid artery.

Between 1978 and 1988, the diagnosis of atheromatous pseudo-occlusion of the internal carotid artery was made in 34 patients by angiography. Results of noninvasive tests were abnormal in 33 of the 34 patients examined. Twenty-five patients had carotid endarterectomy, and the other nine were treated medically. Four of the 34 patients (12%) had significant complications, two related to angiography and two to surgery. Twenty-three of the 25 operated patients were seen in long-term follow-up; 19 (83%) were found to have a patent operated vessel by noninvasive testing. None of the 23 operated patients followed up suffered recurrent neurologic deficits following surgery; two had distant contralateral strokes. Three of the nine patients treated medically (33%) experienced delayed ipsilateral stroke. This study shows that the risks associated with angiography and surgery for atheromatous pseudo-occlusion are significant and are higher than previously reported.

Chemical dissolution of gallstones: in vitro studies.

Groups of human cholesterol gallstones were subjected to monooctanoin with and without agitation, methyl-tert-butyl ether (MTBE) with and without agitation, and monooctanoin and MTBE used in succession with agitation. In this in vitro study, agitation greatly expedited the rate of dissolution with MTBE, by far the more potent of the two solvents. An additive effect was suggested when the solvents were used sequentially, monooctanoin followed by MTBE. Cholesterol-calcium stones were also dissolved by MTBE but at a slower rate, depending on the amount and distribution of calcium. Computed tomographic (CT) scans and mammographic images clearly delineated the amount and distribution of calcification, but plain radiographs did not. On the basis of these findings, the authors instituted two changes in their clinical protocol: All patients with gallstones are now examined by means of CT before chemical dissolution begins, and monooctanoin is instilled overnight before the MTBE procedure.

Medical influences on birth spacing in rural Mexico.

PIP: In order to determine the impact of the available health services in rural areas on women's reproductive decisions, researchers documented fertility changes in rural Mexico from 1969-1981, determined rates of contraceptive use and breastfeeding, and examined medical personnel attitudes towards these 2 factors. Figures showed that the marital fertility rate of Mexico's rural population dropped from 10.6 children/per woman in 1969 to 8.1 in 1981; the same period saw a drop in the total fertility rate from 7.8 to 5.3. Researchers also noted a reduction in the mean length of breastfeeding, from 17.9 months to 15.1 months, and a rise in the use of contraception, from 1.9% to 33.8%. Knowledge about contraception increased significantly during the period, with doctors becoming an important vehicle for the its promulgation. Though doctors favored breastfeeding over bottlefeeding, they usually recommended shorter breastfeeding periods and early supplementation. Traditional midwives, however, recommended longer breastfeeding duration and later supplementation. This indicates the effects of health services in rural areas: where it is present, there is a significant positive impact on contraceptive use and some negative impact on breastfeeding. Overall, researchers conclude that Mexico's family planning program is working among its rural population, but point out some weaknesses, such as the lack of medical attention at delivery, medical personnel's ignorance over the possible adverse effects of early suspension of lactation and early supplementation. This suggests the need for some reeducation of the medical personnel.^ieng

[Use of maternal health services in rural Mexico]. / Utilización de los servicios de salud materna en el México rural.

PIP: Because of the spread of western health care into rural Mexican communities through primary health care programs and medical school graduates performing their year of community service, the proportion of rural Mexican women whose deliveries were attended by physicians increased from 17.7% in 1969 to 45.8% in 1981. The primary objective of this work is to identify factors involved in the utilization of the modern medical system for prenatal care and of hospital delivery in transitional rural areas. A secondary objective is to evaluate the impact of modern prenatal care and hospital delivery on perinatal and neonatal mortality. The data came from a 1981 survey by the Mexican Institute of Social Security of a nationally representative sample of 7953 fertile-aged women in 410 communities with fewer than 2500 inhabitants. The survey provided information on both utilization of health services and on medical and biological conditions that might have prompted women to seek modern medical care. This study was limited to 1579 pregnancies which arrived at term in the 13 months preceding the survey. Among dependent variables, the variable for prenatal care was a 1st prenatal visit in the 1st 5 months of pregnancy. 486 women, about 31% of the sample, had such a visit. 69% of the subsample of 1579 women had had some form of prenatal care, of whom 63% had their 1st consultation in the 1st 5 months. 36% of deliveries occurred in hospitals. There were 64 prenatal or neonatal deaths in the 1579 pregnancies, including 38 deaths in the 1st month and 26 stillbirths. The independent variables included 5 factors measuring health facilities available in the community, 3 assessing the commercial center used by the community, and 2 assessing the respondent's housing. The 2 individual factors were birth order and education. 7 factors concerned symptoms of pregnancy and 4 complications during delivery. The multivariate analysis of these factors was carried out by logistic regression. The availability of different types of health services in the community was not a significant predictor of utilization of prenatal services, but existence of a good road was associated with a 30% increase in probability of using medical services and presence in the community of persons speaking only an indigenous language was associated with a 57% decline in probability. Use of prenatal services and hospital delivery were also associated with maternal educational level and housing characteristics. The results appear to indicate the isolation, poverty, and lack of familiarity with western culture constitute important barriers to use of modern maternal health services. The analysis suggests that the policy of providing medical facilities at the community level has had little effect on the extremely disparate use of prenatal care and hospital delivery in rural Mexico.^ieng

The influence of health care on contraceptive acceptance in rural Mexico.

This paper offers two types of evidence in support of the idea that family planning services are most expediently provided as an integral part of the health and medical organization for maternity care. First, prenatal care and medical attention at delivery are found to be closely associated with postpartum contraceptive acceptance in a 1981 survey of family planning in rural Mexico. Second, interviews of a sample of doctors, nurses, and auxiliaries who provide maternal health services to the rural population reveal that these practitioners favor long birth intervals and small completed families, that they recommend the use of modern contraceptive methods including female sterilization, and that those in the employ of public institutions are motivated to recruit acceptors of these methods. The main impediment to contraceptive acceptance in this context is believed to be fear of side effects and permanent health consequences rather than the desire for additional children.

PIP: The institutions and, to an even greater degree, the individuals who provide maternal and child health care services have not occupied a prominent place in recent discussions on the determinants of fertility and contraceptive use. Yet, from the woman's perspective, the use of a modern contraceptive method is often a new and frightening alternative with important but unknown health consequences. Moreover, in matters concerning childrearing and reproduction, one could reasonably expect that mothers would be influenced by the counsel of doctors, nurses, and midwives. This paper offers 2 types of evidence in support of the idea that family planning services in rural Mexico are most expediently provided as an integral part of the health and medical organization for maternity care. 1) prenatal care and medical attention at delivery are found to be closely associated with postpartum contraceptive acceptance in 1981 survey of family planing in rural Mexico. 2) interviews of a sample of doctors, nurses, and auxiliaries who provide maternal health services to the rural population reveal that these practitioners favor long birth intervals and small completed families, that they recommend the use of modern contraceptive methods including female sterilization, and that those in the employ of public institutions are motivated to recruit acceptors of these methods. The main impediment to contraceptive acceptance in this context is believed to be fear of side effects and permanent health consequences rather than the desire for additional children.

Mexico: a model for success.

PIP: In Mexico, a 40 year period of political stability and economic advancement, hailed for its high rates of growth in income per capita, rapid urbanization, and impressive gains in indicators of health and education, seemed to come to a halt in the early 1980s. Since the early 1970s, fertility has declined sharply in chronological association with a new population policy and the implementation of a national family planning program. If in 1940 there was no apparent reason for the Mexican state to have much interest in limiting fertility, such was no longer the case by 1970. The General Law of Population that had been passed in 1947 was laced with the expansionist ideology that dominated demographic issues for more that a century; its pro-natalism had been reinforced by health regulations prohibiting the sale and use of contraceptives and by a penal code that made abortion a crime. Between 1970 and 1981 the total fertility rate fell by about 39%. Since 1975, change in contraceptive practice accounts for the bulk of the measured fertility decline. Between 1976 and 1982 there was a 66% increase in contraceptive prevalence. The government's involvement in family planning activities helped to: 1) develop an effective contraceptive distribution system; 2) circulate extensive information, education, and communication publicizing fertility and images of the small family; and 3) mobilize health practitioners in public institutions to counsel and persuade their clients to accept and practice contraception. The emerging debate over population policy in Brazil may well prefigure debates in other Latin American countries; the recent democratization in Brazil is the vocalization of a demand from women's groups and the left for government provided family planning services. Overall, Mexico's willingness to take the long view tackle the birth rate issue head on is likely to remain an exception in Latin America.^ieng

Non-invasive tests as an indicator of carotid stenosis.

Between 1979 and 1985, non-invasive testing was done on 896 carotid arteries prior to angiography. The non-invasive studies included B-scan ultrasound, Doppler, and oculoplethysmography. Estimates of per cent stenosis arrived at by the non-invasive reader was correlated with the degree of stenosis found at angiography. The Pearson correlation coefficient for agreement between the non-invasive studies and angiography was 0.86. The mean absolute difference was 11 per cent. In 50 per cent of cases the results of the two examinations were identical. In 73 per cent of instances the non-invasive result was within 10 per cent of that of angiography. These results indicate that non-invasive testing can be highly accurate in estimating carotid stenosis and can be sustained over time.

[Population and development in Mexico: a synthesis of recent experience]. / Poblacion y desarrollo en Mexico: una sintesis de la experiencia reciente.

Changes in the relationship between population factors and the development process in Mexico from 1940 to the present are reviewed. The authors show how the development that occurred up to about 1970 both absorbed and encouraged rapid population growth. They then describe how the emergence of problems concerning this relationship led to the development of a population policy during the 1970s. "The paper then takes up the implementation of that policy and the determinants of the fertility decline that took place afterwards, and closes with a brief review of the implications that demographic considerations have for Mexico's future." (SUMMARY IN ENG)

The influence of noninvasive tests on the selection of patients for carotid angiography.

To assess the impact of noninvasive testing of the carotid vessels upon patient management, we analyzed the angiographic findings in 494 patients studied between 1978 and 1983 for suspected extracranial cerebrovascular disease. This longitudinal study revealed two changes in the pattern of angiographic results after introduction of noninvasive testing in the final months of 1979. The proportion of examinations that revealed less than 49% stenosis decreased significantly from 49% in 1978 to 19% in 1983 (p less than 0.001). During the same time, the proportion of examinations identifying 75-99% stenosis increased from 20% to 62% (p less than 0.001). The referring physicians and their patient population appeared to remain unchanged over these years. We believe the decline in patients with little or no disease is a consequence of better patient selection due to screening with noninvasive tests. We credit the increase in patients with 75-99% disease to additional patients identified by noninvasive tests. This study also points out that the role of noninvasive studies will necessarily be restricted because of inherent limitations in the techniques and that clinical judgment will remain the final arbiter with regard to the management of patients at risk for stroke.

Inflammation-induced increases in dolichol synthesis and hydroxymethylglutaryl-coenzyme A reductase activity in mouse liver are prevented by a high-cholesterol diet but not by fasting.

The inflammatory response in mammals is characterized by the synthesis in the liver of several N-linked serum glycoproteins called acute-phase reactants. In C57BL/6J mice, turpentine-induced inflammation was accompanied by increases in 3-hydroxy-3-methylglutaryl-coenzyme A reductase activity, dolichol synthesis, and dolichyl phosphoryl mannose synthesis. Cholesterol feeding, but not fasting, prevented these inflammation-induced increases in reductase activity and dolichol synthesis. However, the rate of incorporation of [3H]mannose into total serum glycoproteins was not affected by the high-cholesterol diet, and this rate increased during acute inflammation in control and cholesterol-fed mice.

Different tissue concentrations and rates of synthesis of dolichol, dolichyl acyl esters, and dolichyl phosphate in mouse testes and preputial glands.

The rates of synthesis and tissue concentrations of dolichol derivatives differ markedly in testes and preputial glands from adult C57BL/6J mice. In testes, the rates of free dolichol, dolichyl acyl esters, and dolichyl phosphate synthesis were approximately 5,000, 4,000 and 2,000 dpm/3h/g, respectively. Comparable rates for preputial glands were 12,000, 60,000 and 0 dpm/3h/g. Thus in testes, dolichyl phosphate represented 15-20% of total dolichol synthesis, whereas no de novo dolichyl phosphate synthesis was detected in preputial glands. In testes, free dolichol was the predominant derivative synthesized; in preputial glands, 80% of dolichol synthesized was esterified to fatty acids. The concentration of total dolichol (free alcohol plus acyl esters) was 160 micrograms/g tissue in testes and 1270 micrograms/g tissue in preputial glands. In both tissues, 85-90% of dolichol was esterified to fatty acids, and no dolichyl phosphate was detected.