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PubMed2006

Mother-to-child transmission of different HIV-1 subtypes among ARV Naïve infected pregnant women in Nigeria.

The rate of mother-to-child transmission (MTCT) of HIV as well as the implications of the circulating multiple subtypes to MTCT in Nigeria are not known. This study was therefore undertaken to determine the differential rates of MTCT of HIV-1 subtypes detected among infected pregnant women before ARV intervention therapy became available in Nigeria. Twenty of the HIV-positive women who signed the informed consent form during pregnancy brought their babies for follow-up testing at age 18-24 months. Plasma samples from both mother and baby were tested for HIV antibody at the Department of Virology, UCH, Ibadan, Nigeria. All positive samples (plasma and peripheral blood mononuclear cells-PBMCs) were shipped to the Institute of Tropical Medicine, Antwerp, Belgium, where the subtype of the infecting virus was determined using the HMA technique. Overall, a mother-to-child HIV transmission rate of 45% was found in this cohort. Specifically, 36.4%, 66.7% and 100% of the women infected with HIV-1 CRF02 (IbNg), G and B, respectively, transmitted the virus to their babies. As far as it can be ascertained, this is the first report on the rate of MTCT of HIV in Nigeria. The findings reported in this paper will form a useful reference for assessment of currently available therapeutic intervention of MTCT in the country.

Adult↗

PubMed2005

[Ethics and medical research: principles, guidelines, and regulations].

The issue of ethics in medical research grew in importance at the end of World War II, after the Nuremberg Code. In this period, some cases in the United States had demonstrated the need for the establishment of rules and procedures in medical research. In this article, the authors discuss some ethical concepts and their philosophical basis, stressing aspects related to research. Ethics in medical research is based upon three items: peer approaches, subject informed consent, and confidentiality of individual obtained data. The authors also summarize the Brazilian laws and directives to follow the precepts and to control the process of ethical issues in research with human participants. Finally, they approach practical questions of the Informed Consent Form as a consequence of their experiences analyzing more than one thousand research projects per year as members of the Internal Review Board of the University of São Paulo School of Medicine, São Paulo, Brazil.

Biomedical Research↗

PubMed2004

[Caries prevalence in 4-year-old preschoolers attending public schools in Recife, Pernambuco, Brazil].

The aim of this study was to determine caries prevalence in 4-year-old preschoolers of both sexes in municipal schools in Recife, Pernambuco, Brazil, in 2002, emphasizing their needs assessment. Data were collected by examining 861 preschoolers from 45 municipal schools. Examination was conducted by one examiner (Kappa = 1) in the school and after parental consent forms were obtained. Dental caries was recorded using the dmf-t (decayed, missing, and filled teeth) index. Data analysis showed caries prevalence of 47.00% and dmf-t of 2.06. Only 6.40% of the children had their teeth treated. The examined children showed high dental caries prevalence (47.00%), despite a low prevalence of severe caries (8.94%).

Brazil↗

PubMed2002

Caries prevalence and risk factors among children aged 0 to 36 months.

The aim of this study was to assess the prevalence of caries and risk factors in outpatients of the Pediatric Ambulatory of the Pedro Ernesto University Hospital aging up to 36 months. After signing informed consent forms, the parents answered a structured questionnaire in order to evaluate risk factors for dental caries, including socioeconomic status, oral hygiene and dietary habits. A single investigator carried out the dental examination which assessed the presence of caries, biofilm and gingival bleeding. The data were analyzed by means of the Epi Info program, utilizing the chi-squared test. The children's mean age was 22.9 months. The prevalence of caries, including white spot lesions, was 41.6%, and the mean def-s was 1.7 (+/- 2.5). The most affected teeth were the maxillary incisors, and the most common lesion was the white spot. No significant associations were found between the prevalence of caries and socioeconomic status, frequency of oral hygiene, nocturnal bottle- and breast-feeding or cariogenic food and beverage intake during the day. However, the association between caries and oral hygiene quality (dental biofilm) was statistically significant (p < 0.001). The results suggest that the presence of a thick biofilm was the most important factor for the occurrence of early childhood caries in the evaluated sample.

Biofilms↗

PubMed2004

Oral rehabilitation under dental general anesthesia, conscious sedation, and conventional techniques in patients affected by cerebral palsy.

The purpose of this report is to find the use of different alternatives for dental treatment, from general anesthesia to conventional techniques, in patients affected by cerebral palsy (CP) in a dental school setting. The sample was divided into two groups: (1) children, and (2) adolescents and young adults; 38 patients (20 female and 18 male) with diagnostic of CP were included. Risks and benefits of conscious sedation and general anesthesia were written into a consent form and these were discussed with parents or guardians of each affected patient. The mean age was 7.14+/-2.2 years for children's group and 18.5+/-3.06 years for adolescent and young adult group. Most children (77.3%) were classified as ASA II with a level of behavior I-II according to Frankl's scale and these patients were treated under general anesthesia (GA). For patients that were classified as of positive behavior with little necessity of dental procedures, independent of the medically compromised level, dental treatment was done with conventional techniques or with conscious sedation. Dental frequency procedures were as follows: composites, dental prophylaxis, and dental extractions in children; in adolescents and adults, important to point out is that in anterior teeth and molars endodontic treatment, and surgical procedures increased in frequency. The mixture sevoflurane-propofol worked well during pre-, peri-, and post-operative procedures. During the discharge process, most patients needed a recovery of 20-40 minutes after which they were awake and oriented, breathing comfortably with stable vital signs. It was concluded that GA with sevoflurane-propofol and conscious sedation are an excellent tool to provide dental treatment in CP patients in a dental school setting without most of the major postoperative complications, such as nausea and vomiting.

Adolescent↗

PubMed1997

Carbon dioxide laser for de-epithelialization of periodontal flaps.

Regeneration of mineralized and soft connective tissue components of the attachment apparatus is the main goal in the treatment of periodontal diseases. Often, apical migration of epithelium (long junctional epithelium) effectively prevents the formation of bone and connective tissue attachment after periodontal surgery. The purpose of the present study was to compare conventional periodontal surgery combined with carbon dioxide laser and conventional periodontal surgery alone with respect to epithelial elimination and degree of necrosis of mucoperiosteal flaps. After signing a consent form, five patients with at least two comparable bilateral periodontal defects needing pocket elimination surgery participated in this study. The investigators randomly divided each side into test and control sites. Each patient received oral hygiene instruction and initial therapy prior to surgery. At surgery, the test site received a sulcular incision and carbon dioxide laser de-epithelialization of the outer and inner aspects of the flap. The control group received reverse bevel incision only. The surgeon performed open flap debridement on all teeth. At the time of surgery, the surgeon did a biopsy of each site and submitted specimens for histologic evaluation. A matched pairs t-test was used to analyze the data. The results show significant differences between the carbon dioxide laser and reverse bevel incision with respect to sulcular (P < or = 0.025) and gingival (external) (P < or = 0.01) flap surface epithelial elimination and tissue necrosis (P < or = 0.005). These results should be replicated with a larger number of subjects. The carbon dioxide laser eliminated sulcular and gingival (external) epithelium without disturbing underlying connective tissue. This finding supports the concept that the carbon dioxide wavelength has little or no effect on tissues beyond the target. However, neither laser nor blade eliminated all the epithelium. Researchers observed chronic inflammation in the control and test sites, with a predominance of plasma cells. Lining the sulcular and gingival (external) lased areas, investigators found coagulation necrosis covered by fibrin and coagulated blood. The laser appears to effectively remove epithelium at the time of surgery; however, future long-term, well-controlled quantitative histologic studies are needed to evaluate the effect of repeated carbon dioxide laser de-epithelialization of the gingival (external) surface of mucoperiosteal flaps at intervals during the healing period.

Biopsy↗

PubMed2000

Long-term treatment with subantimicrobial dose doxycycline exerts no antibacterial effect on the subgingival microflora associated with adult periodontitis.

BACKGROUND: The purpose of this study was to determine whether treatment with subantimicrobial dose doxycycline (SDD), 20 mg bid, exerted an antimicrobial effect on the microflora associated with adult periodontitis. METHODS: Following the approval of the protocol and informed consent forms by the respective IRBs at the University of Florida and West Virginia University, 76 subjects with adult periodontitis were entered and randomly assigned to receive SDD or placebo. A split-mouth design was utilized, with each subject receiving subgingival scaling and root planing (SRP) in two quadrants immediately following baseline data collection, while the remaining two quadrants were left unscaled (non-SRP). Microbial samples were collected prior to treatment, after 3, 6, and 9 months of treatment, and after 3 months of no treatment. The samples were examined by microscopy and by enumeration on selective and non-selective media. RESULTS: All treatments resulted in statistically significant decreases in the proportions of spirochetes and motile rods (P <0.05) and in an increase in the proportion of coccoid forms (P <0.0001) relative to baseline. No between-treatment differences were detected between the SDD and placebo treatments in either the SRP or non-SRP design, with the exception of the small and large spirochetal groups. The spirochetal proportions present in the SDD group were significantly lower (P<0.05) than the paired placebo group during the 9-month treatment and was preceded by a significant decrease (P<0.01) in the proportion of microbiologic sample sites that bled on probing. No between- treatment differences were detected in any of the other microbial parameters. CONCLUSION: The microbial differences observed were attributed to the anticollagenase and anti-inflammatory properties of SDD and not to an antimicrobial effect.

Adult↗

PubMed2005

Hematological change in venous blood of the lower leg during prolonged sitting in a low humidity and hypobaric environment.

The present study examined the effects of low humidity and hypobaric conditions on hematological change in venous blood of the lower leg during quiet prolonged sitting. Ten healthy male students participated as the subjects after singing a consent form to participate in this study. Their diet and water intake were controlled from 19:00 on the day before the experiments. The subjects sat for 130 min in a climatic chamber. Four experimental conditions in the chamber were designed from a combination of relative humidity (20% or 60%) and air pressure (sea level or equivalent to an altitude of 2,000 m). Ambient temperature was maintained at 24 degrees C in every condition. Venous blood was sampled from the lower leg before and after exposure to the experimental conditions, and was analyzed for blood viscosity and hematological indices. Also, body weight and leg circumference were measured as indices of total water loss and edema, respectively. Regarding the results of ANOVA, significant interactions between humidity and time were observed in blood viscosity, red blood cell count and hematocrit (each p<0.05). However, there were no significant differences in these indices among the conditions. Significant increases were observed in leg circumference (p<0.01), platelet count (p<0.05) and total protein (p<0.05) after the exposure compared with those before the exposure. There were no noticeable effects of hypobaric conditions in every measurement. In conclusion, prolonged sitting seems to be a more hazardous factor for thrombogenesis low humidity and hypobaric conditions during a long-distance flight.

Adult↗

PubMed1999

The return of thalidomide: can birth defects be prevented?

Thalidomide, the drug that caused a worldwide epidemic of serious birth defects in the late 1950s and early 1960s, was recently approved by the US Food and Drug Administration (FDA) for use in treating the skin disease erythema nodosum leprosum, a complication of leprosy. The drug has also shown promise in the treatment of other serious diseases. If thalidomide is eventually approved for use in the US and other countries for treatment of diseases more prevalent than erythema nodosum leprosum, or if use of the drug for non-approved indications becomes widespread, hundreds of thousands of women with childbearing ability could be treated. If this should happen, can we prevent another epidemic of birth defects? In an effort to prevent fetal exposures to thalidomide, the FDA mandated a comprehensive programme to regulate prescription, dispensing and use of the drug. The programme is designed to require registration of all participating prescribers, pharmacies and patients. It also requires use of effective methods of contraception and periodic pregnancy testing of all patients with childbearing ability during treatment. Prescribers are directed to counsel both female and male patients on the risks, benefits and proper use of the drug, as well as on the proper use of contraceptives during treatment. The patient is required to sign an informed consent form before beginning treatment. Prescription and dispensing of thalidomide will be tightly controlled. Athalidomide registry will monitor prescription. dispensing and use of the drug, and will investigate all reported fetal exposures. This mandatory, but untested, programme promises to be effective at preventing fetal exposures to thalidomide, provided that patients, prescribers and pharmacists comply with all of its provisions. However, even if the programme proves to be successful in the US, there is concern that thalidomide may eventually be widely used in countries that may not require such stringent controls. In Brazil, where thalidomide is commercially available for treatment of leprosy patients, 33 cases of thalidomide embryopathy have already been reported in the literature. Even in countries that may tightly regulate the distribution and use of thalidomide, some patients may obtain the drug through black market sources. Should these events occur, many cases of thalidomide-induced birth defects could appear. Therefore, there is a need to develop nonteratogenic analogues of thalidomide that can provide effective treatment for erythema nodosum leprosum and other serious conditions without increasing the potential for another epidemic of thalidomide-related birth defects.

Adult↗

PubMed2003

Isotretinoin use and subsequent depression and suicide: presenting the evidence.

The growing number of reported cases of depression and suicide associated with isotretinoin (a retinoid receptor agonist) use in patients with acne has prompted concern among dermatologists, patients, and their relatives and has triggered new warnings from regulators including depression-related, patient-informed consent forms. In establishing a cause-effect relationship, it is useful to judiciously consider whether there is an association, what is the nature of that association, if there is a plausible biological mechanism of action, the validity and reliability of measures used and the strength of study designs. Hoffmann-La Roche estimates that by April 2001 approximately 12 million patients worldwide have used isotretinoin, with 5 million patients in the US.A MEDLINE search between January 1966 and May 14 2003 of the published medical literature found 24 documented cases of isotretinoin-associated depression, with 3 suicides. One additional patient committed suicide during the fourth month of isotretinoin treatment and 3 further patients attempted suicide by taking an overdose of isotretinoin. The US FDA's Adverse Event Reporting System (AERS) contains almost 23,000 reports for isotretinoin from its approval in 1982 to December 2002. As of November 30, 2002, AERS contained 3,104 reports (US and foreign) with at least one reported psychiatric event. The FDA is aware of 173 reports of suicide (both US and foreign) in association with isotretinoin. Reports of positive dechallenge and rechallenge present a strong signal pointing to an association between isotretinoin and depression. A Hoffmann-La Roche sponsored epidemiological study failed to find any evidence of an association between isotretinoin and depression or suicide. However, the design of the study was flawed and the evidence was deemed inconclusive. Further studies using strong study designs, reliable and valid measures, and adequate sample sizes may bring us closer to the answer. The evidence suggesting a relationship between isotretinoin and depression needs to be weighed against the increasing prevalence of depression among adolescents and young adults and the psychological impact of acne. The literature contains credible evidence that isotretinoin treatment may reduce the psychosocial impact of acne in some patients. At the present time, there is no known pharmacological mechanism that would account for psychiatric symptomatology as a result of isotretinoin treatment; however, retinoid receptors are widely distributed in the brain and more research is needed to ascertain whether they have a role in depression. In the meantime, for the practitioner, the obvious benefit of isotretinoin in treating acne should encourage continued use. However, patients and their relatives must be informed and depressive symptoms should be actively assessed at each visit and, if necessary, referral to a psychiatrist, antidepressant therapy or discontinuation of isotretinoin should be considered.

Acne Vulgaris↗

PubMedDate not supplied

[Liver transplantation from living related donors]

OBJECTIVES: To present the experience with the first 12 living related liver transplants performed at Hospital Sírio-Libanês in São Paulo. METHODS: The donors were the fathers (6) and the mothers (6) with age ranging from 30 to 48 years. All candidates for donation were submitted to a full informed consent form, clinical and radiological evaluation and had blood withdrawn for autotransfusion. Recipient age ranged from 7 months to 10 years whereas recipient weight varied from 6.3 to 34 kg. Six patients were considered as high risk due to complications of advanced liver disease and were submitted to urgent transplantation. RESULTS: Mean donor hospital stay was 10 days with no mortality. Technical complications were observed in 4 recipients. Seven patients presented at least one episode of bacterial, viral or fungal infection. One or more biopsy proven rejection episodes were disclosed in 7 patients. Overall recipient survival was 67%, being 83% for elective cases and 50% for urgent cases. Long term follow up ranged from 8 to 25 months. Seven out of 8 survivors present excellent quality of life and normal liver function. The other patient is currently under reduced immunosuppression due to Epstein-Barr virus infection.CONCLUSIONS: These results demonstrate the safety and viability of living related liver transplantation which, in face of the current donor scarcity, should be considered as a valid option for the treatment of children with end stage liver disease.

Journal Article↗

PubMed2005

Lip augmentation with liquid silicone.

BACKGROUND: Many fillers have been used to augment the lips. One of these that has provided long-term satisfactory results is liquid silicone. OBJECTIVE: To demonstrate the efficacy and safety of lip augmentation with liquid silicone. METHOD: Following a discussion of the benefits and risks of the procedure and the benefits and risks of alternatives and after answering all of the patients' questions, an informed consent form was signed. After obtaining anesthesia with a regional nerve block of the infraorbital and mental nerves, 0.25 to 0.5 cc of liquid silicone (1,000 centistokes) was injected using the microdroplet technique into the vermilion border of both the upper and lower lips. Depending on the desire of the patient, the procedure was repeated monthly. The augmentation of the lips was documented with histology, micrometry, and digital photography. RESULTS: Lip augmentation was achieved gradually during the months following liquid silicone injections into the vermilion border of the lips in the 608 patients studied. Most of the patients requested a second and third injection session. The results were most dramatic in the patients with type I and type II lips and less satisfactory in patients with type III lips. Bruising occurred in the majority of the patients. Eleven patients (2%) developed small palpable granulomas. These granulomas either required no treatment, responded to steroid injections, or were excised. CONCLUSION: The use of liquid silicone remains an effective method of lip augmentation. It returns the adolescent vermilion curl to the lips.

Cosmetic Techniques↗

PubMed2005

Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a "state-of-the-art" clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient. These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the "translational research engines" that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

Academic Medical Centers↗

PubMedDate not supplied

Adolescent preventive health visits: a comparison of two invitation protocols.

BACKGROUND: Adolescent health care in family practice at times creates conflicting responsibilities for parents and their teenagers. In the context of a new adolescent preventive health program in a family practice setting, we compared attendance rates using two invitation protocols, the protocols differing in their emphasis on adolescent autonomy vs parental responsibility. METHODS: One hundred six teenagers in the seventh and tenth grades were invited for preventive health visits with the family nurse and physician using two protocols. Protocol 1 involved obtaining parental consent before approaching the adolescent. With protocol 2, an invitation letter and parental consent form were mailed to the teenager, while a letter of explanation was sent concurrently to the parents. In each case, the letter of invitation was followed up by a telephone call for those who did not respond. The spontaneous response rate (a positive response after receiving the letter), agreement to attend rate (a positive response after receiving the letter or being telephoned), and the attendance rate were determined according to grade, sex, and protocol. RESULTS: The spontaneous response rate was 21%, the agreement to attend rate was 75%, and the attendance rate was 44%. Attendance rates were higher for the girls compared with the boys (54% vs 35%, P = .08) and for the seventh graders compared with the tenth graders (53% vs 31%, P = .03). The spontaneous response rate was lower among the tenth graders using protocol 2 (8% vs 37.5% with protocol 1, P = .04), while the agreement to attend rate and attendance rate did not differ for the two protocols. CONCLUSIONS: Nearly one half of this population of adolescents attended preventive health visits at the family nurse's and physician's initiative. A follow-up telephone call after the initial written invitation resulted in increased participation, while approaching the teenager or parent initially did not make a difference in attendance. This pilot study shows the potential for initiating an adolescent health program in the family practice setting.

Adolescent↗

PubMed1991

Screening for alcohol abuse using CAGE scores and likelihood ratios.

OBJECTIVE: To assess the performance of the CAGE (acronym referring to four questions, see below) questionnaire in discriminating between medicine outpatients with and without an alcohol abuse or dependence disorder. DESIGN: A cross-sectional design of a sample of consecutive patients who received both the alcohol module of the diagnostic interview schedule and the CAGE (Cut down, Annoyed, Guilty, Eye-opener) screening questionnaire. SETTING: The outpatient medical practice of an urban university teaching hospital. PATIENTS: All patients 18 years or older who signed a consent form approved by the university's institutional review board. MEASUREMENT: Calculation of the sensitivity, specificity, receiver operating characteristic (ROC) curve, and likelihood ratio for CAGE scores of 0 to 4. RESULTS: Thirty-six percent of the sample group met criteria for a history of alcohol abuse or dependence. A CAGE score of 2 or more was associated with a sensitivity and specificity of 74% and 91%. The calculated area under the ROC curve was 0.89, whereas the likelihood ratios for CAGE scores of 0 to 4 were 0.14, 1.5, 4.5, 13, and 100, respectively. These ratios were associated with posterior probabilities for an abuse or dependence disorder of 7%, 46%, 72%, 88%, and 98%, respectively. CONCLUSION: Clinicians can improve their ability to estimate a patient's risk for an alcohol abuse or dependence disorder using likelihood ratios for CAGE scores.

Adult↗

PubMed1993

Education literature for Hispanic patients.

A patient tells his home health nurse through an interpreter that he does not understand the treatment consent form. The form is printed in English. The patient understands only Spanish. A young woman learned her child's home antibiotic therapy through a demonstration given in Spanish. She now wants to review the procedure to program the pump that controls the intravenous dose. The manual is printed in English. The young mother understands only Spanish. These examples reflect the growing communication problems facing home care workers who work in Hispanic communities.

Hispanic or Latino↗

PubMedDate not supplied

Comparing the learning outcomes of lecture and self-instruction methods in a senior clinical laboratory science course.

OBJECTIVE: To compare the relative effectiveness of lecture and self-instruction methods of instruction in a senior clinical laboratory science course. DESIGN: Posttest repeated measures design or within subject design. SETTING: The Department of Medical Technology in the School of Allied Health Professions, Louisiana State University Medical Center, New Orleans. PARTICIPANTS: Clinical laboratory science students (27) enrolled in clinical parasitology agreed to participate, which was a sample of convenience. There were 16 females and 11 males; 70% Caucasian, 23% Asian, and 7% African-American. The 2 students who did not sign a consent form were excluded from the study. INTERVENTION: Subjects were taught clinical parasitology course material by 2 different methods of instruction, lecture and self-instruction. All subjects received both treatments. MAIN OUTCOME MEASURE: Examination scores from each half of the course were compared using descriptive statistics and a paired t-test to determine the effectiveness of each instructional format. RESULTS: Results showed no statistically significant difference in learning outcomes between the 2 instructional formats (a = 0.05, p = 0.13). CONCLUSION: The results of the study generally support the hypothesis that the self-instruction method is as effective as the lecture method in teaching clinical parasitology. By incorporating self-instruction into a clinical laboratory science curriculum, many hours of lecture can be eliminated, and students can learn the material at their own pace. Students comprehend the material effectively, and are relieved from some of the intensity of the didactic approach to instruction that dominates clinical laboratory science curricula.

Educational Measurement↗

PubMed1979

Avoiding malpractice claims through better hospital management.

Within the control of hospital management is the capability of reducing malpractice claims through better employee and patient communications. Promises of successful treatment, billing charges and medical procedures that are unexplained, unfamiliarity of hospital management with what constitutes hospital liability, and wrong use of informed consent forms are among the factors that increase chances of bein sued for malpractice.

Consumer Behavior↗