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Functional restoration of implants on the day of surgical placement in the fully edentulous mandible: a case series.

PURPOSE: The purpose of this article is to report the clinical experience and outcome of a study of the functional rehabilitation of 16 completely edentulous mandibles with immediately loaded cross-arch screw-retained hybrid prostheses at the University of Southern California. MATERIALS AND METHODS: After signing informed consent forms 16 patients (9 male, 7 female) aged 47 to 84 years (mean age, 62.6+/-11.6 years) received 90 Brånemark System Mk III dental implants (Nobel Biocare USA, Yorba Linda, CA, USA). Stability and radiographs of the dental implants were evaluated at the time of surgery, at 3 months, at 1 year, and at 3 years post loading. RESULTS: Three implants failed to meet the criteria of success, bringing the cumulative success rate to 96.6%, with a 100% prosthetic success rate at 3 years. Thirty-nine (43.3%) of the dental implants placed were 15 mm in length. Seventy-seven (85.5%) of the dental implants were placed in high-density bone. At 3 years post loading, the average bone loss was -1.2+/-0.1 mm. CONCLUSION: Within the limitations of this study, restoration of implants by unreinforced hybrid prostheses at the time of placement provided satisfactory results. The outcome was stable at 3 years post restoration. Mandibular rehabilitation by functional loading of the implants on the day of the insertion requires the comprehension and proper application of surgical and restorative principles.

Aged↗

Creating a successful school-based mobile dental program.

BACKGROUND: Dental disease is one of the leading causes of school absenteeism for children. This article describes the creation and evolution of the St. David's Dental Program, a mobile school-based dental program for children. METHODS: The dental program is a collaboration of community partners in Central Texas that provides free dental care to low-income children in schools without relying on reimbursements or government funding. RESULTS: Since 1998, the program has provided 132,791 screenings for oral health treatment needs and 38,634 encounters for sealants or treatment. In 2005, the program provided $2.1 million worth of services at a cost of $1.2 million (not including donated services). Factors important to the program's success included sustained funding for general operating costs; well-compensated clinicians to deliver care and experienced human service workers to manage program operations; the devotion of resources to maximize consent form return rates; and the development of strong relationships with school district and individual school staff. CONCLUSIONS: By removing cost, time, transportation, and bureaucratic barriers, the program was able to reach more children than fixed-site clinics. The program was a merging of private and public health dentistries. This model can be useful to other communities in light of the unmet need for dental care and tighter federal, state, and local government budgets.

Adolescent↗

Recruitment of a clinical field trial population: reasons for nonparticipation.

Open-ended telephone interviews were conducted with 294 families who refused participation in a school-based program of professionally applied topical fluoride. While the program was conducted in a flouride-deficient community, the level of topical fluoride contact in the homes of the nonparticipants was high. The traditional antifluoridationist reasons for nonparticipation were not expressed with frequency. Instead, the most frequent reason for returning a negative consent form was that the child was already receiving topical flouride applications from the family dentist. The second most frequent reason was that the child did not wish to participate. Many of the reasons given for nonparticipation were not cogent, suggesting that if the parents had been more informed about the nature of the project and about fluoride in general their responses might have been positive.

Attitude↗

Bronchial responsiveness in an area of air pollution resulting from wire reclamation.

Spirometric data from 86 primary school children living in an area of air pollution resulting from wire reclamation incineration were analysed and compared with 92 non-exposed schoolchildren. There were lower values for forced vital capacity and forced expiratory volume and thus a higher incidence of pulmonary function abnormalities in the children in the polluted area than those in a non-polluted area. There was no significant difference in the prevalence of respiratory symptoms between these two areas when surveyed by a questionnaire. Twenty eight schoolchildren from a non-polluted area and 26 children from the polluted area, who were said to have no respiratory symptoms and for whom consent forms were obtained, were recruited for a bronchial responsiveness test. Nine (35%) of 26 children in the polluted area were responders (less than 50 U) and only one of the control subjects was a responder. The mean (SD) log cumulative dose producing a 35% decrease in respiratory conductance and the minimum cumulative dose required to decrease respiratory conductance from the baseline in the children of the polluted area were significantly lower than that of the control subjects (1.32 (0.37) log units and 1.26 (0.44) log units, respectively, compared with 1.70 (0.10) log unit for both measurements in non-exposed children). These results indicate that air pollution resulting from wire reclamation can produce a detrimental effect on both pulmonary function and bronchial responsiveness in primary schoolchildren who are continually exposed to air pollutants from the time of their birth.

Air Pollutants↗

Medicolegal audit in the West Midlands region: analysis of 100 cases.

One hundred medicolegal cases were analysed to obtain quantitative data about diagnoses and the causes of litigation that affect hospital doctors in the National Health Service. Sixteen actions concerned minor problems that are an unavoidable risk of treatment, and 39 were due to natural causes. In other cases it was debatable whether a medical accident or negligence was responsible. At the end of three years 73 actions had been withdrawn, 12 settled out of court, and one lost in court by the plaintiff, and 14 were pending. Of these 14, nine were likely to reach court on charges of negligence. Contributory causes were failure of communication in 27 and matters connected with the patient's attitude or personality in 20. Because much time and money are spent on cases that should never have started a doctor should sit on the legal aid panel to give advice for medical cases. Also, solicitors should obtain an independent medical opinion when a complaint is first received from a patient. Consent forms should be more informative and give details of what can reasonably be expected from treatment and its possible risks.

England↗

Pilot study of a point-of-use decision support tool for cancer clinical trials eligibility.

Many adults with cancer are not enrolled in clinical trials because caregivers do not have the time to match the patient's clinical findings with varying eligibility criteria associated with multiple trials for which the patient might be eligible. The authors developed a point-of-use portable decision support tool (DS-TRIEL) to automate this matching process. The support tool consists of a hand-held computer with a programmable relational database. A two-level hierarchic decision framework was used for the identification of eligible subjects for two open breast cancer clinical trials. The hand-held computer also provides protocol consent forms and schemas to further help the busy oncologist. This decision support tool and the decision framework on which it is based could be used for multiple trials and different cancer sites.

Adult↗

Ethical review of health research: a perspective from developing country researchers.

BACKGROUND: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs). METHODS: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations. RESULTS: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. CONCLUSION: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.

Academic Medical Centers↗

Temporomandibular joint disk position assessed at coronal MR imaging in asymptomatic volunteers.

PURPOSE: To assess the normal position of the temporomandibular joint (TMJ) disk relative to the condyle by using coronal magnetic resonance (MR) imaging in asymptomatic volunteers. MATERIALS AND METHODS: This study was approved by the review committee for human research, and all subjects signed an informed consent form. Thirty symptom-free volunteers without histories of TMJ disorders underwent standardized clinical examinations. Afterward, bilateral sagittal oblique and coronal oblique MR images were acquired with the patient's mouth opened and closed. The coronal oblique opened- and closed-mouth images were analyzed by using computer software. The medial and lateral edges of both the TMJ disk and the condyle were marked for these imaging examinations by using the section through the posterior 3 mm of the disk. To eliminate the effect of different magnifications and/or distortions, the distance between these points was measured automatically and divided by the largest mediolateral dimensions of the condyle. To assess the reliability of the measurements, four observers evaluated the position of the disk in the coronal plane. To assess the changes in position of the posterior 3 mm of the disk in the coronal plane in the closed- and opened-mouth positions, the Wilcoxon signed rank test for matched pairs was used. Interobserver measurement reliability was evaluated by using interclass correlation coefficients (ICCs). RESULTS: Analysis of the coronal closed-mouth disk position revealed a medial position of the TMJ disk relative to the condyle in 11 (21%) of 52 analyzed joints. In the opened-mouth position, the medial location of the disk was more frequent: 29 (85%) of 34 analyzed joints exhibited a medial position of the disk relative to the condyle in this plane. This increasingly medial position of the disk was statistically significant (P < or = .001). Measurement reliability assessment revealed sufficient results (ICC > or = 0.7). CONCLUSION: At both closed- and opened-mouth MR imaging, a medially located TMJ disk seems to be within the normal range of variation. The disk seems to shift even more medially when the mouth is opened.

Adult↗

Chest radiography with a flat-panel detector: image quality with dose reduction after copper filtration.

PURPOSE: To compare image quality and estimated dose for chest radiographs obtained by using a cesium iodide-amorphous silicon flat-panel detector at fixed tube voltage and detector entrance dose with and without additional 0.3-mm copper filtration. MATERIALS AND METHODS: The study was approved by the institutional ethics committee. All prospectively enrolled patients signed the written consent form. Chest radiographs in two projections were acquired at 125-kVp tube voltage and 2.5-microGy detector entrance dose. The experimental group (38 patients) was imaged with 0.3-mm copper filtration; the control group (38 patients) was imaged without copper filtration. An additional 12 patients were imaged with and without copper filtration and served as paired subject-controls. Three readers blinded to group and clinical data independently evaluated the radiographs for image quality on a digital display system. Twelve variables (six for each radiographic projection) were assigned scores on a seven-point ordinal scale. Scores between experimental and control groups were compared: Logistic regression analysis and Mann-Whitney U test were used for unpaired patients; and Wilcoxon and McNemar test, for paired patients. In all, 72 comparisons were determined (36 [12 variables x three readers] for unpaired patients and 36 for paired patients). In a phantom study, radiation burden of experimental protocol was compared with that of control protocol by using Monte Carlo calculations. RESULTS: For 70 of 72 comparisons, digital radiographs obtained with copper filtration were of similar image quality as radiographs obtained without copper filtration (P = .123 to P > .99). For two of 72 comparisons, one observer judged the experimental protocol superior to the control protocol (P = .043, P = .046). Patient dose reduction estimated with Monte Carlo calculations was 31%. Use of copper filtration increased exposure times by 48% for posteroanterior views and by 34% for lateral views. CONCLUSION: Subjectively equivalent chest radiographic image quality was found with estimated 30% dose reduction after addition of 0.3-mm copper filtration with flat-panel cesium iodide-amorphous silicon technology.

Cesium↗

Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study.

Green tea catechins (GTCs) proved to be effective in inhibiting cancer growth in several experimental models. Recent studies showed that 30% of men with high-grade prostate intraepithelial neoplasia (HG-PIN) would develop prostate cancer (CaP) within 1 year after repeated biopsy. This prompted us to do a proof-of-principle clinical trial to assess the safety and efficacy of GTCs for the chemoprevention of CaP in HG-PIN volunteers. The purity and content of GTCs preparations were assessed by high-performance liquid chromatography [(-)-epigallocathechin, 5.5%; (-)-epicatechin, 12.24%; (-)-epigallocatechin-3-gallate, 51.88%; (-)-epicatechin-3-gallate, 6.12%; total GTCs, 75.7%; caffeine, <1%]. Sixty volunteers with HG-PIN, who were made aware of the study details, agreed to sign an informed consent form and were enrolled in this double-blind, placebo-controlled study. Daily treatment consisted of three GTCs capsules, 200 mg each (total 600 mg/d). After 1 year, only one tumor was diagnosed among the 30 GTCs-treated men (incidence, approximately 3%), whereas nine cancers were found among the 30 placebo-treated men (incidence, 30%). Total prostate-specific antigen did not change significantly between the two arms, but GTCs-treated men showed values constantly lower with respect to placebo-treated ones. International Prostate Symptom Score and quality of life scores of GTCs-treated men with coexistent benign prostate hyperplasia improved, reaching statistical significance in the case of International Prostate Symptom Scores. No significant side effects or adverse effects were documented. To our knowledge, this is the first study showing that GTCs are safe and very effective for treating premalignant lesions before CaP develops. As a secondary observation, administration of GTCs also reduced lower urinary tract symptoms, suggesting that these compounds might also be of help for treating the symptoms of benign prostate hyperplasia.

Administration, Oral↗

Comprehension of written health care information in an affluent geriatric retirement community: use of the Test of Functional Health Literacy.

BACKGROUND: The comprehension of written health care information, e.g. prescription bottle labels or an informed consent form, impacts on communication with patients and their ability to understand medical procedures, as well as goals of therapy. OBJECTIVE: To determine if the problem of literacy was present in a population of affluent Albuquerque retirement community dwellers. METHODS: We administered the Test of Functional Health Literacy in Adults (TOFHL) to 93 residents (71 women and 22 men), using a one-on-one directed examination conducted by one of the authors (J.G.B.). RESULTS: The group studied had a mean age of >70 years, were not acutely ill, had no known loss of mental function, were better educated and had a high standard of living compared to national standards. However, 30% (95% confidence level) of our group were unable to adequately comprehend written information as measured by the TOFHL. The subgroup with poor comprehension (21 women and 7 men) had a mean age of 85 years (versus 82 years in the group with good comprehension) and a mean of 13 years (versus 15 years in the group with good comprehension) of formal education. Multivariate analysis was consistent with a negative effect of age (p = 0.04), a positive effect of years of formal education (p = 0.0005) and no effect of gender on the TOFHL score. CONCLUSION: Two recent studies, one in an emergency room setting and the other among Medicare enrollees, demonstrated similar results to ours. The high prevalence of poor comprehension in these groups should alert providers to the need to develop additional or different communication skills that can address the problem of poor reading comprehension across at least three diverse groups of people, with particular attention to those over the age of 65.

Aged↗

Field trial on caries prevention with xylitol candies among disabled school students.

BACKGROUND: In a 1999 survey high caries levels were found among physically disabled school students in Kuwait. OBJECTIVES: A field study was planned to test the efficacy of xylitol candies in preventing caries among individuals in two special schools in Kuwait. METHODS: Altogether 176 students were examined in 2002 and 145 (105 in xylitol group and 40 in the control group) after 18 months' intervention. The WHO criteria were used in recording caries according to surfaces (third molars were excluded) by 2 calibrated examiners (E.H., M.S.). The students were allocated to the xylitol group only if the parent/caregiver returned the informed consent form. School health nurses distributed xylitol candies to the students 3 times during the school day (after breakfast and lunch, and before leaving the school). RESULTS: In the xylitol group, the baseline DS and DMFS scores were 3.4 and 8.2 and in the follow-up 1.9 and 7.1, respectively. In the control group, the baseline scores were DS 3.9 and DMFS 9.8, and the follow-up scores DS 3.9 and DMFS 13.2. CONCLUSION: Xylitol seemed to have a strong preventive and a clear remineralizing effect on caries.

Adolescent↗

Delay in diagnosis of Williams syndrome.

Williams syndrome (WS) is a well-known genetic disorder with a variable phenotype. In many cases, physical manifestations are subtle and may not be apparent at an early age, making diagnosis difficult in infants and young children who lack classic manifestations such as supravalvular aortic stenosis and hypercalcemia. Clinical suspicion is essential because the diagnostic genetic finding is not detectable on routine chromosomal analysis. Furthermore, early diagnosis allows for earlier detection and treatment of developmental, behavioral, and medical problems. In an effort to understand how and why individuals with WS are diagnosed, we conducted a survey-based study of parents of WS children. Packets containing a cover letter, consent form, parental survey and preaddressed stamped envelope were distributed to parents of children with WS. The survey included questions concerning initial diagnosis, WS findings present, medical specialists involved, and tests performed. Forty-six completed surveys were returned for analysis. The mean age at diagnosis was 3.66 years (SD 4.13). The mean age at which there were initial concerns was 0.98 year (SD 1.24) resulting in a mean delay in diagnosis of 2.77 years (SD 4.10). In addition, the involvement of a geneticists correlated with earlier diagnosis (2.26 years vs. 5.09 years without geneticist involvement, p = 0.03) and fewer tests ordered (5.2 vs. 8.2 in the nongeneticist group, p = 0.0006). We observed a significant delay in the diagnosis of WS. Of note, the involvement of a geneticist was associated with earlier diagnosis and reduced number of tests.

Adolescent↗

Home phototherapy. An alternative to prolonged hospitalization of the full-term, well newborn.

Hyperbilirubinemia in the healthy, term neonate is the most common reason for prolonged hospitalization. Expense, separation from a nursing mother, imparting a sense of illness to the infant, and disrupting such processes as "bonding" are all drawbacks to in-hospital phototherapy. Home Phototherapy Associates in Colorado Springs, Colorado has treated 260 newborns from April 1982 to February 1985. The infants treated by home phototherapy averaged 0.81 days of hospital phototherapy before being discharged to home phototherapy for an average of 2.44 days. Average bilirubin on entry into home phototherapy was 14.19 mg/dl and 10.97 mg/dl when discontinued. The average age upon entering home phototherapy was 3.97 days. Home phototherapy was ordered at the discretion of the private physician. Parents were given verbal and written instructions on care of the jaundiced newborn, kept a record of their baby's progress and signed a consent form. There have been no complications in 260 newborns treated at home. There were 17 rehospitalizations. Home phototherapy is an effective and safe alternative to prolonged hospitalization for the healthy, full-term newborn with jaundice. Parental satisfaction has been nearly 100 percent. The average daily decrement in bilirubin is comparable with that reported by others for in-hospital phototherapy. The cost savings, uninterrupted "bonding" process, and the ability to keep mother and child united are some of the observable benefits.

Bilirubin↗

Use of continuous subcutaneous insulin infusion (insulin pump) therapy in the hospital setting: proposed guidelines and outcome measures.

PURPOSE: Individuals whose diabetes is being treated in the outpatient setting via an insulin pump often wish to maintain this therapy during hospitalization. The authors propose guidelines for management of patients on insulin pumps who require a hospital admission. METHODS: A collaborative interinstitutional task force reviewed current available information regarding the use of insulin pumps in the hospital. RESULTS: There was little information in the medical literature on how to manage individuals on established insulin pump therapy during a hospital stay. The task force believed that a policy that promotes patient independence through continuation of insulin pump therapy while ensuring patient safety was possible. A set of contraindications for continued use of pump therapy in the hospital are proposed. A sample patient consent form and order set are presented. Finally, measures that can be used to assess effectiveness of an inpatient insulin pump policy are outlined. CONCLUSIONS: Patients on established insulin pump therapy do not necessarily have to discontinue treatment while hospitalized. However, clear policies and procedures should be established at the institutional level to guide continued use of the technology in the acute care setting.

Adult↗

A molecular epidemiology project on diet and cancer: the EPIC-Italy Prospective Study. Design and baseline characteristics of participants.

EPIC-Italy is the Italian section of a larger project known as EPIC (European Prospective Investigation into Cancer and Nutrition), a prospective study on diet and cancer carried out in 10 European countries. In the period 1993-1998, EPIC-Italy completed the recruitment of 47,749 volunteers (15,171 men, 32,578 women, aged 35-65 years) in 4 different areas covered by cancer registries: Varese (12,083 volunteers) and Turin (10,604) in the Northern part of the country; Florence (13,597) and Ragusa (6,403) in Central and Southern Italy, respectively. An associate center in Naples enrolled 5,062 women. Detailed information for each individual volunteer about diet and life-style habits, anthropometric measurements and a blood sample was collected, after signing an informed consent form. A food frequency questionnaire specifically developed for the Italian dietary pattern was tested in a pilot phase. A computerized data base with the dietary and life-style information of each participant was completed. Blood samples were processed in the same day of collection, aliquoted (RBC, WBC, serum and plasma) and stored in liquid nitrogen containers. Follow-up procedures were validated and implemented for the identification of newly diagnosed cancer cases. Cancer incidence was related to dietary habits and biochemical markers of food consumption and individual susceptibility in order to test the role of diet-related exposure in the etiology of cancer and its interaction with other environmental or genetic determinants. The comparability of information in a prospective study design is much higher than in other studies. The availability of such a large biological bank linked to individual data on dietary and life-style exposures also provides the unique opportunity of evaluating the role of selected genotypes involved in the metabolism of chemical compounds and DNA repair, potentially related to the risk of cancer, in residents of geographic areas of Italy characterized by specific cancer risk and different dietary patterns. Baseline characteristics of participants are briefly described.

Adult↗

Postabortion research: methodological and ethical issues.

The author conducted research on long-term postabortion experience guided by the principles of phenomenology, and she describes the ethical and methodological issues encountered during the study, in which she interviewed 17 women who were more than 5 years postabortion, in this article. Discussed here, in the context of abortion as a sensitive topic for researcher and participant, are personal bias; recruitment, protection, and interviewing of participants; data analysis; and communication of findings. During the research process, the author gave particular attention to the formulation of the consent form, contact with the participants, the interview technique, the choice of a transcriptionist, and the use of a second reader. She also acknowledged her personal position on abortion, the reality of role conflict, and the importance of debriefing.

Abortion, Legal↗

Practical assessment of adult literacy in health care.

Low literacy is a pervasive and underrecognized problem in health care Approximately 21% of American adults are functionally illiterate, and another 27% have marginal literacy skills. Such patients may have difficulty reading and understanding discharge instructions, medication labels, patient education materials, consent forms, or health surveys. Properly assessing the literacy level of individual patients or groups may avoid problems in clinical care and research. This article reviews the use of literacy assessments, discusses their application in a variety of health care settings, and cites issues providers need to consider before testing. The authors describe informal and formal methods of screening for reading and comprehension in English and Spanish including the Rapid Estimate of Adult Literacy in Medicine, the Wide Range Achievement Test-3, the Cloze procedure, the Test of Functional Health Literacy in Adults, and others. Practical implications and recommendations for specific use are made.

Achievement↗