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At least 793 records · Page 44Linked to original sources

Increasing amniotic fluid magnesium concentrations with stable maternal serum levels: a prospective clinical trial.

OBJECTIVE: To compare the effect of prolonged maternal intravenous MgSO4 administration on amniotic fluid and serum concentrations of magnesium over time in preterm labor patients. STUDY DESIGN: Patients at 24-34 weeks of singleton gestation who presented with contractions (> 8 in 60 minutes) underwent amniocentesis to rule out intrauterine infection after signing an informed consent form. Some of these women who were clinically judged to have preterm labor received intravenous MgSO4: a 4-g loading dose followed by a 2 g/h maintenance dose. For technical reasons some patients had amniocentesis performed before initiation of MgSO4 (controls), while others had the procedure during tocolytic therapy (study subjects). Duration of treatment until amniocentesis was recorded, and blood samples were drawn at the time of amniocentesis. Maternal serum and amniotic fluid magnesium levels were measured using a colorimetric end point method. Data were evaluated using the Student t test and linear regression analysis. RESULTS: Mean magnesium levels in maternal serum rose from 1.74 +/- 0.2 mg/dL in controls to 4.01 +/- 0.4 mg/dL in the study group. Mean magnesium levels in Mean magnesium levels in amniotic fluid were 1.41 +/- 0.18 mg/dL in the controls versus 2.28 +/- 0.53 mg/dL in the treatment group. Duration of MgSO4 treatment ranged from 3 to 22 hours. Amniotic fluid magnesium concentrations increased significantly during therapy (correlation coefficient = 0.89; p < 0.001), while maternal serum levels remained stable over time (correlation coefficient between maternal serum levels and time = -0.39; p=0.34). CONCLUSION: Although maternal serum magnesium levels remained stable with intravenous MgSO4 therapy, concentrations continued to rise in amniotic fluid over time. However, amniotic fluid magnesium levels never exceeded maternal serum concentrations during the study period.

Adult↗

[Papillomavirus and factors associated with high-risk, cervical intraepithelial neoplasia in Cauca, Colombia].

OBJECTIVE: Evaluating the role of the main factors associated with high-risk cervical intraepithelial neoplasia in women from the Cauca Department in Colombia. METHODOLOGY: After signing a consent-form, women were interviewed to obtain socio-demographic and lifestyle data. A cervical biopsy was performed on each woman for histopathological diagnosis (cases) and a sample of exfoliated cells (cases and controls) to extract DNA for HPV detection by polymerase chain reaction. A total of 98 cases and 109 controls, matched by age and ethnicity, were recruited for the study. RESULTS: The study confirmed association between HPV and the risk of cervical neoplasia (OR = 19.0; 95% CI = 8.20-44.2). The data suggested that multiparity (OR = 4.1; 95% CI = 1.62-10.6) and exposure to carcinogens present in wood-smoke (OR = 7.3; 95% CI = 3.00-19.4) are important co-factors for cervical neoplasia given the presence of HPV. CONCLUSIONS: These results provide valuable information for public health institutions to develop better cervical neoplasia prevention programmes.

Adolescent↗

Walking, body composition, and blood pressure dose-response in African American and white women.

PURPOSE: The purpose of this study was to evaluate body composition and blood pressure (BP) responses to a 16-week dose of brisk walking in sedentary and obese African American (AA) and White women. METHODS: Seventy-five sedentary women (45 AA and 30 White) between the ages of 18 and 50 years and body fat > or =27% signed institutional approved informed consent forms and volunteered to participate in this study. The participants were divided into four groups (AA exercisers [AAE], AA control [AAC], White exercisers [WE], White controls [WC]). The exercisers walked three miles a day, three days a week. Body composition and BP were measured before and after the training intervention. Food records were collected before, during, and after the intervention. RESULTS: Following training, only the WE experienced a reduction in body weight and body fat (P<.05). However, the energy intake of the AAE increased 4.7% during and 16% at the conclusion of the intervention and contributed to them neither losing nor gaining weight or fat. Both exercise groups experienced reductions (P<.05) in systolic (AAE 5.7 mm Hg, WE 11.3 mm Hg) and diastolic BPs (AAE 3.0 mm Hg, WE 3.6 mm Hg) following training, but the reductions for the WE were greater (P<.05) than for the AAE. There were no changes in body composition or BP for either AAC or WC. CONCLUSIONS: These results indicate that a 16-week walking intervention provides body composition and BP benefits for both AA and White women, but the benefits are greater for White women.

Adult↗

Rapid assessment of literacy levels of adult primary care patients.

Health education materials, medical instructions, consent forms, and self-report questionnaires are often given to patients with little regard for their ability to read them. Reading ability is rarely tested in medical settings. The Rapid Estimate of Adult Literacy in Medicine (REALM) was developed as a quick screening tool to assist physicians in identifying patients with limited reading skills and in estimating patient reading levels. This information can be used to tailor materials and instructions to patients' abilities. The REALM and the reading sections of the Peabody Individual Achievement Test-Revised and the Slosson Oral Reading Test were used to test reading ability in 207 adults in six public and private primary care clinics. REALM scores correlated highly with those of the standardized reading tests. The REALM, which takes three to five minutes to administer and score, appears to be a practical instrument to estimate patient literacy in primary care, patient education, and medical research.

Adolescent↗

The substance-abusing family: consideration for nursing research.

Investigations to explore and document the characteristics of addicted families are possible for nurse researchers in a variety of settings. Addicted families can be identified through hospitals, clinics, or community substance abuse treatment centers. Confidentiality issues must be addressed with carefully designed consent forms. A thorough understanding of addicted family systems is essential. System, role, and family theories provide a framework for understanding the influence of substance abuse on all family members. Anticipation of common social, economic, and criminal crises of addicted families will assist the researcher to avoid conflicts between research and service. Methodological limitations are common in research with addicted families, but well-designed, descriptive studies with small- to moderate-sized self-selected samples can add greatly to our nursing knowledge base over time.

Confidentiality↗

Do patients understand written health information?

Long sentences, medical terms and small print make hospital information brochures and consent forms difficult for many patients to understand. There are, however, things nurses can do to make written information for patients more accessible.

Communication Barriers↗

Cryopreservation and storage of human bone marrow: a survey of current practices.

As bone marrow transplantation is being used with increasing frequency, problems of storage space and cost, inventory control and disposal have arisen. Issues such as maximum storage time and acquisition of consent for marrow disposal need to be addressed before a large inventory is accumulated. Consideration should also be given to using non-infused marrows for research purposes. Eighty-three bone marrow transplant centers were surveyed in an attempt to establish a data base with regard to guidelines for storage of cryopreserved human bone marrow. Fifty-two centers (62.7%) responded to the questionnaire, 5 of which did not have an active cryopreservation program. The remaining 47 centers freeze and store autologous marrow from patients with leukemia, lymphoma, neuroblastoma and a large diversity of other conditions including solid tumors. Twelve centers (25.5%) specify maximum storage times of up to 5 years, but only 9 centers (19.1%) require the donor to sign a specific consent form for marrow disposal if it is not used for transplantation within a given time. Eighty-five percent of the responding centers reinfuse at least half of the marrows they freeze within 12 months of harvesting. It appears that at least 90% of marrows that are being reinfused have been stored for three years or less. However, the storage time of non-infused marrows extends even further, and autologous marrow has been reinfused successfully as long as eight years after storage.

Bone Marrow Transplantation↗

Registry of unrelated bone marrow donors.

Reports of successful transplantation of bone marrow obtained from unrelated donors who were histocompatibility leukocyte antigen (HLA) identical prompted the Canadian Red Cross Blood Transfusion Service in Ottawa to assess the possibility of developing a bone marrow donor registry in Canada. We sent a pamphlet that explained the program to 1568 people who had undergone apheresis and asked them to reply, stating their interest. At the same time the pamphlets and a poster were placed in the blood donor clinic. We received 1232 replies (78.6%) from the apheresis donors, 838 (68.0%) of which indicated a willingness to attend information sessions. Of the 7158 people who gave blood during the 3-month study period, 225 (3.1%) were interested. At the time this paper was written 47 information sessions had been held, and 721 people had attended, 624 (86.5%) of whom had signed a consent form. This indicates a clear interest in a bone marrow donation program. We believe that the ethical issues are overcome by requesting the donation before identification of any patient. From our experience a national registry of unrelated donors seems feasible, and steps are being taken to implement such a program.

Blood Component Removal↗

[Information before basaloma surgery--results of an inquiry].

We report on the results of an empirical investigation on medical information before surgery of basaliomas. The study comprised 42 patients who had been informed. The given information was documented by consent forms. In the second year after surgery, all patients received a detailed questionnaire. One aim of the investigation was to find out which particulars of the verbal and written information they still kept in mind. 26 questionnaires were returned. Evaluation showed that some patients had completely forgotten that information about complications of surgery had been given at all. Only one of the patients could name a special complication of treatment.

Basal Cell Carcinoma↗

The reactions of patients to a video camera in the consulting room.

In a general practice survey of reactions to the presence of a video camera in the consulting room 13 per cent of patients refused to be filmed, and 11 per cent of those who did consent disapproved of recording. Patients were more willing to express their reservations about video recording if asked to fill in a questionnaire later at home rather than immediately at the surgery. Patients with anxiety, depression, or problems relating to the breasts or reproductive system were more likely to withhold consent. Patients were less likely to refuse video recording of their consultation if they were asked by the doctor for their verbal permission as they entered the consulting room rather then if they were asked to sign a consent form. Only a small minority of the patients who refused to be filmed felt that this refusal had affected their consultation with the doctor.

England↗

Medical management of the sexually assaulted woman.

Public concern about the sexual assault victim demands that the medical profession be better prepared to evaluate such patients. Modern guidelines for the medical evaluation and treatment of such victims are provided. A list of supplies for a "rape tray" and guidelines for obtaining laboratory tests are included. A detailed patient consent form and laboratory chain of evidence form will facilitate care. A plea is made for legislative support to pay for lab work and the establishment of state or national laboratories equipped to handle evidentiary material.

Female↗

Risks of unoccluded topical steroids in clinical trials.

Data were reviewed on the beneficial responses and adverse reactions among 2,849 patients in 14 paired-comparison studies with eight unoccluded topical corticosteroids in six steroid-responsive dermatoses. Adverse reactions were found to be mild, transient, and, for the most part, rare. Of 5,698 treatment exposures, 249 (4.39%) adverse reactions were reported, including irritation (1.3%), itching (0.95%), burning (0.81%), dryness (0.46%), scaling (0.30%), and vesicle formation (0.16%). Other reactions occurred in less than one in 1,000 treatment exposures. No severe reactions were observed. Five subjects (0.17%) terminated treatment early because of adverse reactions. The incidence of adverse reactions to vehicle alone was 6.7%. The benefit-risk ratio for mild reactions was 17:1. Therefore, long lists of adverse reactions are inappropriate in written consent forms for prospective volunteers for clinical trials. Al alternative warning statement is proposed.

Administration, Topical↗

Experimental therapy of sickle cell disease. Use of hydroxyurea.

PURPOSE: Therapy of sickle cell disease with hydroxyurea is experimental. PATIENTS AND METHODS: We have begun a randomized blinded clinical trial to determine its clinical utility. The efficacy of this drug is unproved and its risks, which include mutagenesis, teratogenesis and carcinogenesis, are poorly understood. These risks are explicitly stated in our consent forms. A significant number of patients who are asked to enroll refuse to enter the study. This refusal is probably because of individual variations in perception of risk and personal inconvenience, as well as differences in perception of personal benefit. We have a few hints as to which patients are more likely to produce increased amounts of fetal hemoglobin, but our findings do not indicate which patients are most likely to show a good clinical response. RESULTS: Our study group decided not to treat patients under 18 years of age with hydroxyurea until clinical efficacy of the drug is proved in adults. We have criteria for selecting patients for entry into our ongoing study, but the criteria are based more on study design than on an estimate of present or future severity of the manifestations of sickle cell disease. CONCLUSIONS: Features of our previous study and results of the present trial may be helpful in defining indications for bone marrow transplantation in children with sickle cell disease.

Anemia, Sickle Cell↗

An investigation of non-response bias by comparison of dental health in 5-year-old children according to parental response to a questionnaire.

Non-response bias is a potentially serious problem in studies involving human subjects. A parental questionnaire/negative consent form was used in a dental epidemiological survey of 5-year-old children in Leeds. The aim of this study was to determine whether and to what extent there was any variation in caries experience and oral cleanliness between responding and non-responding groups. 6,494 children were examined and completed questionnaires were returned for 4,069 (63 per cent). The response was higher for white children (65 per cent) than for Asian (39 per cent) and Afro-Caribbean children (45 per cent). Lower response rates were found from parents living in inner city areas associated with social deprivation. Children of non-responders had poorer oral cleanliness and higher caries experience (mean dmft). This study demonstrated that members of a non-response group are likely to be substantially different from responders.

Attitude to Health↗

Screening for HIV and hepatitis B virus in Los Angeles County prenatal clinics: a demonstration project.

A project designed to pilot voluntary screening for HIV antibody and hepatitis B virus antigen (HBsAg) in women using Los Angeles County Department of Health Services prenatal clinics is described. The purpose of the study was to demonstrate that HIV testing could be integrated into an existing prenatal health care system with minimal disruption. In an 8-month period, 9,069 women entered the project; 76% accepted HIV antibody testing. The rate of HIV antibody seropositivity was 144 per 100,000 (10 per 6,943), and the rate of HBsAg seropositivity was 253 per 100,000 (23 per 9,103). No difference in test acceptance rates was found using a sign-off versus a sign-on HIV antibody consent form although potential confounders were not controlled. Only five of the eight HIV antibody-positive women (63%) and eight of the 20 HBsAg-positive women (40%) who were interviewed reported behaviors considered high risk for HIV or HBsAg infection.

Adult↗

Control of epidemic group A meningococcal disease in Auckland.

AIM: To study group A meningococcal vaccine delivery to infants less than 2 years of age in Auckland in 1987 to control epidemic disease. METHODS: Mechanisms of vaccine delivery and its facilitation are described. A detailed audit of delivery of vaccine to children less than two years using signed consent forms determined delivery source. This was the age group at highest risk, and poorly covered by routine childhood vaccines. Primary health care source of children presenting with disease was determined by telephone. RESULTS: The epidemic of group A meningococcal disease in the winters of 1985 and 1986 abated most likely due to the vaccination of high risk children (3 months-13 years) in 1987. 90% of the target population were vaccinated. In south Auckland the majority (92%) of vaccine doses for children less than two years of age was delivered by the Plunket Society with Department of Health backing aided by community health workers. By contrast delivery by, general practitioners was greater in north-west and central Auckland (approximately 25%, of dose 1), especially after the publicity over possible side effects (approximately 50% of dose 2). Coverage for dose 1 of children < 2 years was similar (89%) in south Auckland. Of children presenting with meningococcal disease 1 in 4 did not have an identifiable general practitioner. CONCLUSIONS: Vaccines to prevent serious paediatric illness are known to be highly cost effective. The best method of delivery of vaccinations may vary from area to area. Major community involvement including community health workers for the Maori and Pacific Island communities may have facilitated the dissemination of information in this campaign.

Adolescent↗

Improving patient education for patients with low literacy skills.

Patients who misunderstand their diagnosis and treatment plans usually exhibit poor compliance. The 90 million adult Americans with low literacy skills struggle to understand such essential health information as discharge instructions, consent forms, oral instructions and drug labels. The Joint Commission on Accreditation of Health Organizations (JCAHO) now requires that instructions be given on a level understandable to the patient. Most physicians tend to give too much information on too high a level for many patients to understand. Physicians who speak in simpler language, repeat their instructions and demonstrate key points, while avoiding too many directives, enhance their patients' understanding. Combining easy-to-read written patient education materials with oral instructions has been shown to greatly enhance patient understanding. To be effective with patients whose literacy skills are low, patient education materials should be short and simple, contain culturally sensitive graphics and encourage desired behavior. Compliance with therapy also may be improved by including family members in the patient education process.

Aged↗

Sealant status and factors associated with sealant presence among children in Milwaukee, WI.

To determine the percent of school-children aged 6-14 years with sealants placed in their permanent molars in the City of Milwaukee. 2) To describe factors associated with sealant presence among these children. 3) To describe differences, if any, among ethnic majority and minority groups. Twelve public schools agreed to participate in this project. After consent forms were obtained, 1,234 dental exams were performed. A 15-item pretested questionnaire was given to each child to take home for the parent(s) to complete. Response rate was 60 percent (N = 742). Data were analyzed using frequencies and Chi-Square tests (P-value < 0.05). Only 9.6 percent of the sample had sealants on their permanent molars. Variables that were found associated with children more likely to have sealants included: gender (female children more likely than males); children with a recent dental exam; children having a regular dentist; parents having heard about sealants before this study; parents' correct knowledge regarding the purpose of sealants; higher level of parents' education; higher parents' total annual income; ethnicity (Caucasian children more likely than Hispanic, African American, American Indian, or Asian children); and age (children in the older group, 10-14 years, more likely than children in the younger group, 6-9 years). Percent of school-children with sealants on their permanent molars in the city of Milwaukee is low. Efforts are needed to increase the knowledge of sealants by the general public as well as to promote sealant use by dentists in both private practice and public health programs, especially for minority children.

Adolescent↗