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PubMedDate not supplied

Importance and timing of sexual counseling after myocardial infarction.

BACKGROUND: This study examined differences in the perceptions of the importance and timing of sexual counseling in patients with myocardial infarction (MI). METHODS: Using a longitudinal descriptive prospective design, subjects were identified from the discharge records of three health-care agencies after having experienced an acute MI in the last 4 to 8 weeks. The Sexual Counseling Needs of MI Patients Survey and a consent form were mailed to patients at 2, 4, and 6 months after MI. Patients (N = 91) rated the importance and timing of 14 sexual counseling items using a Likert scale (1 to 5), and reported the preferred method of education. The possible range for the importance score was 14 to 70. RESULTS: Mean importance ratings for each of the 14 items at each of the data collection periods ranged from 3.28 to 4.59. The mean overall importance score at 2 months (56.96), 4 months (56.52), and 6 months (55.19) reflected the importance of these items for teaching. There was no significant difference between importance scores at each of these time periods. Subjects were divided as to when sexual counseling should occur, in hospital or after discharge, for items related to specific sexual counseling. The most preferred educational method at 2, 4, and 6 months after MI were written materials, followed by individual discussion, and a videotape to watch at home. CONCLUSIONS: Patients validated the importance of each of the specific areas for sexual counseling after MI. The timing and educational methods for sexual counseling must be further addressed in future research. Sexual counseling initiated in the acute-care setting and continued throughout the recovery period can impact the quality of life of patients with MI and their partners.

Adult↗
PubMedDate not supplied

Patients' fear of genetic discrimination by health insurers: the impact of legal protections.

PURPOSE: The impact of laws restricting health insurers' use of genetic information has been assessed from two main vantage points: (1) whether they reduce the extent of genetic discrimination and (2) whether they reduce the fear of discrimination and the resulting deterrence to undergo genetic testing. A previous report from this study concluded that there are almost no well-documented cases of health insurers either asking for or using presymptomatic genetic test results in their underwriting decisions, either before or after these laws, or in states with or without these laws. This report evaluates the perceptions and the resulting behavior by patients and clinicians. METHODS: A comparative case study analysis was performed in seven states with different laws respecting health insurers' use of genetic information (no law, new prohibition, mature prohibition). Semistructured interviews were conducted in person with five patient advocates and with 30 experienced genetic counselors or medical geneticists, most of whom deal with adult-onset disorders. Also, multiple informed consent forms and patient information brochures were collected and analyzed using qualitative methods. RESULTS: Patients' and clinicians' fear of genetic discrimination greatly exceeds reality, at least for health insurance. It is uncertain how much this fear actually deters genetic testing. The greatest deterrence is to those who do not want to submit the costs of testing for reimbursement and who cannot afford to pay for testing. There appears to be little deterrence for tests that are more easily affordable or when the need for the information is much greater. Fear of discrimination plays virtually no role in testing decisions in pediatric or prenatal situations, but is significant for adult-onset genetic conditions. CONCLUSION: Existing laws have not greatly reduced the fear of discrimination. This may be due, in part, to clinicians' lack of confidence that these laws can prevent discrimination until there are test cases of actual enforcement. Ironically, there may be so little actual discrimination that it may not be possible to initiate good test cases.

Ethics, Medical↗
PubMed2005

Pneumothorax as a complication of breast augmentation.

BACKGROUND: Pneumothorax is a recognized complication of breast augmentation which, until now, was thought to be rare. The authors hypothesize that it is more common than generally appreciated. METHODS: A fax survey was sent to 363 members of the California Society of Plastic Surgeons in 2001, questioning their experience with this complication. RESULTS: The survey response rate was 50 percent, revealing that one in three members of the California Society of Plastic Surgeons had at least one patient who experienced a pneumothorax, and one in 10 had experienced two or more complications of pneumothorax while performing breast augmentation. Sixty-two members reported a total of 83 separate pneumothoraces in their career. No local or hypodermic needle injections were used in 24 percent of these patients. Fifty-five percent of patients were hospitalized, with 71 percent of the cases paid for by insurance companies. Treatment consisted of observation and repeated chest radiograph in 33 percent, needle aspiration alone in 16 percent, and chest tube insertion in 47 percent. CONCLUSIONS: The cause is difficult to determine, but causes suspected by respondents included intraoperative laceration of the pleura (43 percent), needle puncture at the time of local injection (37 percent), ruptured pulmonary blebs during or after the procedure (16 percent), and high anesthetic ventilation pressures (3 percent). The authors believe the complication of pneumothorax is more common than generally appreciated and is not necessarily caused by negligence. The authors now include this complication in their consent form and recommend keeping an intracatheter, pigtail catheter, or Heimlich valve in surgical facilities for treatment of a possible tension pneumothorax.

California↗
PubMed2003

Long-term outcomes in pediatric renal transplant recipients who survive into adulthood.

BACKGROUND: Long-term results in renal transplant recipients who underwent transplantation as children are often buried within the outcomes of adult centers, leaving a void in our knowledge regarding this unique cohort. The authors aim to describe the long-term outcomes of children who experienced renal failure and subsequently underwent transplantation during childhood and who have now reached adulthood, with an emphasis on social and economic rehabilitation. METHODS: Two hundred seventeen children were identified who underwent transplantation between 1967 and 1999. Of those 217174 who were born before October 1982 and who would therefore have reached adulthood were selected for study. A questionnaire and consent form were sent to the surviving 132 patients of this subpopulation. RESULTS: Fifty-seven adult survivors answered the questionnaire. No significant differences were found comparing the respondents to the nonrespondents. Nearly half of all respondents were severely short and 27% were obese. Questionnaire respondents had high rates of hypertension, bone and joint symptoms, fractures, hypercholesterolemia, and cataracts. Despite significant remaining health issues, 82% of respondents were employed, 95% reported their health as "fair" or "good," 61% reported "no" or "minor" physical limitations, and 82% described themselves as "just as" or "more content than others." Nearly 50% of the respondents were married, and the overwhelming majority reported satisfaction in their sexual lives. CONCLUSIONS: Despite a high retransplantation rate and the presence of significant morbidity, renal transplantation in children can lead to attainment of a productive and satisfying life, with a high degree of rehabilitation in adulthood.

Adolescent↗
PubMed1991

Drug testing of athletes.

Drug testing policies have been enacted affecting a large number of athletes. Complex, wide-ranging technical questions are raised by drug testing programs designed for athletes. Issues are also raised concerning the structural elements commonly included in a substance abuse policy affecting athletes. The selection of particular athletes for testing, random drug testing, consent forms, constructing a list of banned substances, the handling, collecting and transporting of testing samples, and selected flaws and limitations affecting the drug testing process are among the topics covered in this article.

Doping in Sports↗
PubMed2005

Comparison of directed and self-directed learning in evidence-based medicine: a randomised controlled trial.

OBJECTIVES: To compare 2 educational programmes for teaching evidence-based medicine (EBM). DESIGN: Prospective randomised controlled trial accompanied by a qualitative evaluation. SETTING: University of Oslo, Norway, 2002-03. PARTICIPANTS: A total of 175 students entered the study. All tenth semester medical students from 3 semesters were eligible for inclusion if they completed baseline assessment and consent forms and either attended teaching on the first day of the semester or gave reasons for their absence on the first day in advance. Interventions One intervention was based on computer-assisted, self-directed learning (self-directed intervention), whilst the other was organised as workshops based on social learning theory (directed intervention). Both educational interventions consisted of 5 half-day sessions. MAIN OUTCOME MEASURES: The primary outcomes were knowledge about EBM and skills in critical appraisal. A secondary outcome measured attitudes to EBM. Outcomes were compared on an intention-to-treat basis using a stratified Wilcoxon rank-sum test. RESULTS: There were no differences in outcomes for the 2 study groups in terms of EBM knowledge (mean deviation 0.0 [95% confidence interval - 1.0, 1.0], P = 0.8), critical appraisal skills (MD 0.1 [95% CI - 0.9, 1.1], P = 0.5), or attitudes to EBM (MD - 0.3 [95% CI - 1.4, 0.8], P = 0.5). Follow-up rates were 96%, 97% and 63%, respectively. CONCLUSIONS: This trial and its accompanying qualitative evaluation suggest that self-directed, computer-assisted learning may be an alternative format for teaching EBM. However, further research is needed to confirm this and investigate alternative educational models.

Adult↗
PubMed2006

Attitudes toward participation in a pregnancy and child cohort study.

While epidemiological studies aim for high participation rates, it is becoming increasingly difficult to recruit and retain participants in lengthy observational studies. We surveyed women who recently participated in the Pregnancy, Infection, and Nutrition Study during their pregnancy to learn more about what initially motivated them to participate in the study, their attitudes about the study protocol, and whether they would allow their child to participate in future studies. Most women were motivated by their interest in science and learning about their pregnancy. In general, women felt quite comfortable with most aspects of the study. Consent forms, telephone interviews and self-administered questionnaires were the most acceptable components of the study, but even specimen collection was well tolerated by this cohort. Women were less comfortable with the possibility of their child participating in future research. This survey confirmed that once women are enrolled, they tend to be willing to complete most components of an intensive study, suggesting that initial efforts for recruitment are most important.

Adult↗
PubMed2001

Proposed practice guidelines for continuous contact lens wear.

The introduction of silicone-containing hydrogel contact lenses (SCHCLs) for continuous wear (CW) presents practitioners with a unique challenge. To facilitate the transition, we propose a set of guidelines for the conduct of CW practice. The general concepts for the guide are derived from a range of similar codes of practice that have been produced for a range of aspects of eye care. The more general competencies required of eye care practice are assumed and are not discussed in detail. The document is based on the precept that the prescription of SCHCLs is an appropriate practice for suitably screened patients. Practitioners should acquire general and specific knowledge of information applicable to CW with SCHCLs. Support staff should be educated to handle a range of requirements specific to CW. There are no consulting room facilities required beyond those necessary for general optometric practice but we highly recommend that the CW practitioner use grading scales for anterior eye complications and a guide to corneal infiltrative conditions. More stringent examination protocols are required than for general contact lens practice, particularly in the selection of the patient. Patient management should be conducted to a medical standard of care. Documentation is critical and will involve general information about the product, an agreement, disclosure of risk factors, instructions for wear and care, recording of patient questions and answers provided, an informed consent form and detailed, accurate record keeping. A guideline such as this document cannot be positioned as a legal standard of care, but may be used in the formulation of such a standard.

Journal Article↗
PubMed2005

New life after prostate brachytherapy? Considering the fertile female partner of the brachytherapy patient.

OBJECTIVES: To examine several cases of unusual and unexpected pregnancy in the female partners of men treated with brachytherapy for cancer of the prostate. PATIENTS AND METHODS: Self-reported pregnancy of partners of patients who had had prostate brachytherapy was assessed. The dosimetry to the testicles and sperm counts were used to examine the feasibility of pregnancy in the partners. RESULTS: Three reported cases of pregnancy showed the men to have viable counts of within several or all of the parameters of the World Health Organisation criteria for normal semen analysis. CONCLUSIONS: These cases provide a cautionary tale and suggest that all men being treated with prostate brachytherapy should be counselled about the possibility of continued fertility. Documentation of this 'risk' on the consent form will allow for proper discussion of this issue in a clinical and medicolegal context. The key to addressing this problem is to propagate much better patient information. The topic should be addressed clearly in information booklets for the patients. Prostate brachytherapy may allow for pregnancy to be achieved in the fertile partners of patients, even after full radiation treatment of the patient.

Adult↗
PubMed2006

Solaria use in Queensland, Australia.

OBJECTIVE: To describe the demographics of solarium users and the correlates of solarium use in Queensland. METHODS: A cross-sectional survey of 9419 Queensland residents was conducted via an anonymous computer-assisted telephone interview. RESULTS: Overall, 8.8% of the respondents had ever used a solarium and less than 1% had used a solarium in the previous year. Results indicated that users were more likely to be female and younger than non-users, and less than half of the users signed a consent form, suggesting that they had not been made aware of the associated risks by operators. CONCLUSIONS: The Queensland Cancer Risk Study was one of the first population-based studies to address solarium use in this State and highlights that the use of solariums in Queensland is low in comparison to other countries. IMPLICATIONS: There is no regulation of compliance with guidelines. It may become necessary to make compliance with the guidelines mandatory to effectively communicate the associated risks.

Adult↗
PubMed2004

Quality of care, teaching responsibilities, and patients' preferences.

A 42-year-old woman presenting to an academic medical center with low back pain radiating down her left leg was deemed to be a good candidate for a lumbar epidural steroid injection after undergoing a thorough evaluation. The procedure along with all the possible attendant side effects were thoroughly explained to the patient who readily signed the consent form. The patient was prepped and positioned, but, upon seeing that a resident rather than her attending doctor would be doing the procedure, she objected, insisting that the attending do the procedure. The attending explained that she was in a teaching hospital, where residents commonly do procedures under close supervision of attending physicians. Nevertheless, the patient still insisted on whom she wanted to do the procedure and became visibly agitated. How do you accommodate the training needs of medical students, residents, and fellows while maintaining adequate care for patients? Does the "see one, do one, teach one" principle commonly practiced in academic settings compromise the bioethical principles of nonmaleficence and beneficence? What should the attending do in this case with the patient on the table? What are the patient's rights here versus the needs of the training setting?

Adrenal Cortex Hormones↗
PubMed1992

Screening for drinking disorders in the elderly using the CAGE questionnaire.

OBJECTIVE: To assess the performance of the CAGE questionnaire in identifying elderly medicine outpatients with drinking problems. DESIGN: Cross-sectional design, with the alcohol module of the Diagnostic Interview Schedule as the criterion standard. SETTING: The outpatient medical practice of an urban university teaching hospital. PATIENTS: Consecutive patients 18 years or older who signed a consent form approved by the university's institutional review board. For this study, 323 patients greater than or equal to 60 years old. MAIN OUTCOME MEASURES: Sensitivity, specificity, receiver operating characteristics (ROC) curve and positive predictive value for CAGE scores of 0-4 for patients 60 years or older. RESULTS: Thirty-three percent of the sample group met study criteria for a history of drinking problems, including 63% of the male patients and 22% of the female patients. The sensitivity and specificity for a cut-off score of one for all patients was 86% and 78%, respectively, and 70% and 91% for a cut-off of two. The calculation of the area under the ROC curve was .86, and the positive predictive value of CAGE scores of 0-4 were 33%, 66%, 79%, 82%, and 94%, respectively. The predictive value for any score was higher in males than females, reflecting the higher prevalence of problems in the male population. CONCLUSIONS: The CAGE can effectively discriminate elderly patients with a history of drinking problems from those without such a history. The chosen cut-off score should consider the prevalence of drinking problems in the population being tested.

Aged↗
PubMed2005

The first ambulatory screening on thromboembolism: a multicentre, cross-sectional, observational study on risk factors for venous thromboembolism.

OBJECTIVES: To assess the prevalence of risk factors for venous thromboembolism (VTE) and the prevalence of recent (<1 year) VTE [including superficial vein thrombosis (SVT), deep vein thrombosis (DVT) and pulmonary embolism (PE)] amongst patients attending general practitioner (GP) surgeries. DESIGN: Multicentre, cross-sectional, observational study. SETTING: A total of 1536 GP surgeries. PARTICIPANTS: A total of 15 180 adult, co-operative subjects, who had consulted their GP for a health disorder and signed the informed consent form. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Prevalence of known VTE risk factors graded according to importance and prevalence of recent (<1 year) VTE events (including SVT), based on interviews. RESULTS: About 1:5 patients had at least one strong risk factor and about 1:20 had at least two risk factors, with no difference between sexes. The prevalence of strong risk factors increased with age. Most were related to medical conditions: history of SVT and/or DVT/PE, heart failure and malignancy. About 3:4 women and 2:3 men had at least one moderate to weak risk factor; nearly 1:2 women and 1:3 men had at least two moderate to weak risk factors. The most common were: history of VTE, smoking, history of miscarriage, estrogen therapy, obesity, and varicose veins. Overall, 80% women and 67% men had at least one risk factor, and 50% women and 35% men had at least two risk factors. The prevalence of recent (<1 year) VTE was 3.4% in women and 2.4% in men, and increased with age. The majority of cases were SVT in both sexes (2.5% in women and 1.5% in men). CONCLUSIONS: The prevalence of risk factors for VTE amongst patients attending GP surgeries is high. GPs should bear this in mind during their daily practice.

Adolescent↗
PubMed1996

Structure and practice of institutional review boards in the United States.

OBJECTIVE: The institutional review board (IRB) is a critical element in the protection of patients' and subjects' rights with regard to their participation in research protocols. The purpose of this study was to describe the structure and current practices of IRBs in the United States. METHODS: A self-administered questionnaire was mailed to the IRB chair of each U.S. hospital with a capacity of at least 400 beds (n = 907). The survey contained 21 questions outlining committee size and structure, review of research proposals, and policies concerning scientific misconduct. Chairs also were asked what advice they would offer a young investigator preparing a proposal for submission. RESULTS: A total of 488 surveys (54%) were returned; 447 of the responding institutions had an IRB committee. Committees had an average of 14 members, representing 27 medical specialties. Orthopedics had the least IRB representation (10% of committees), followed by emergency medicine (12%) and ophthalmology (15%). The majority of research proposals go through 5 specific steps once submitted for review. Common reasons for proposal rejection were improperly designed consent form (54%), poor study design (44%), unacceptable risk to subjects (34%), ethical or legal reasons (24%), and scientific merit (14%). When a research proposal is rejected, 86% of the responding IRBs assist the investigator in making appropriate revisions. Although a number of IRBs (17%) have dealt with scientific misconduct allegations, only 58% have a written policy regarding research integrity. CONCLUSION: Despite variations in committee structure and representation, IRBs have similar procedures for governing research. Investigators should be familiar with these procedures and are encouraged to discuss their proposal with an IRB representative prior to formal review.

Ethics, Institutional↗
PubMed2005

The Health Insurance Portability and Accountability Act (HIPAA): its broad effect on practice.

The Health Insurance Portability and Accountability Act (HIPAA), and its final rule, raised fears among practitioners of new and complex regulations that might interfere with medical practice, lead to inadvertent liability and unwanted expense. It generated a dizzying set of health-care administrative activities and a new work for legal consultants. It has extensive scope, and includes most health plans and practitioners. It has regulated both privacy and security, including electronic, paper, and oral communications. However, after a HIPAA compliant office structure is established, and the privacy notice is reviewed and signed by the patient, disclosure of medical information for treatment, payment or "health-care operations" is permitted without recurrent consent forms, thus allowing substantially familiar patterns of doctor-to-doctor communication about treatment. Further, the initial approach to enforcement appears to some legal observers to be more likely corrective rather than punitive, although providers remain uneasy over the mere possibility of criminal penalties. As regards medical research, uncertainties about the application of HIPAA seem less resolved and more variably interpreted by different institutions, with ongoing fear in the research community that important public health and epidemiologic research activity may be compromised by well meaning IRBs using inconsistent, overly strict or erroneous interpretation of the intent of HIPAA regulations.

Biomedical Research↗
PubMed1994

Effect of chlorhexidine (0.12%) rinses on periodontal tissue healing after tooth extraction. (I). Clinical parameters.

The aim of the present study was to evaluate the effects of a 1-month period of chlorhexidine (CHX) rinses on the periodontal conditions of teeth adjacent to extraction sockets. 40 patients signed consent forms for this double blind trial and were randomly assigned to either the test group rinsing 2 x daily with 15 ml of a 0.12% CHX solution (Peridex) starting 2 days after tooth extraction or the control group rinsing with a placebo solution for 30 days. Clinical periodontal parameters were obtained from test sites located adjacent to as well as matched controls distant to the extraction sites. The measurements were performed at baseline before the extraction and 1, 2, 3 and 6 months thereafter. During the observation period, the patients were exposed to initial periodontal therapy. The test sites of the group rinsing with CHX demonstrated significantly reduced (p < 0.05) plaque indices, gingival indices and lower %s of sites bleeding on probing one month following the extraction. The test sites of the control group rinsing with the placebo demonstrated a tendency for loss of clinical attachment between 1 and 2 months after the tooth extraction. The mean pocket probing depth (PPD) at test sites of the CHX rinsing group was smaller than in the placebo rinsing group at the one month examination. Also, the mean PPD of the test sites in the CHX group was significantly smaller than at the control sites at 1 month. This difference was not observed in the control group rinsing with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1995

Guided tissue regeneration in the treatment of degree III furcation defects in maxillary molars.

11 subjects with generalized periodontitis and advanced lesions in the maxillary molar regions, including bilateral mesial-distal, but not buccal, degree III furcation defects in the 1st and/or 2nd molars, were recruited for the present clinical trial. The patients were given oral hygiene instruction and full-mouth scaling and root planing. A re-examination was performed after 3 months of healing, after which the furcation involved molars were randomly selected for a GTR or conservative treatment modality. An informed consent form was signed by each participating patient. The GTR procedure involved the elevation of mucoperiostal flaps, root surface debridement, and the placement of an e-PFTE membrane at the 2 entrances of the furcation defect. The flaps were repositioned and secured. The contralateral molar was treated in an identical manner but without the placement of the teflon membrane. The patients received amoxicillin (1g x 2/day for 8 days), were placed on chlorhexidine mouth rinsing and were recalled for prophylaxis 1x every 2 weeks. The teflon membranes were removed at a 2nd stage procedure after 6 weeks. All subjects were re-examined 6 months after the regenerative procedure, and in addition, all sites were evaluated following a reentry procedure. The final examination and measurements made during the reentry procedure documented that, although some reduction in probing pocket depth and some gain in probing attachment had occurred at both test and control sites, none of the furcation defects had closed, but retained the characteristics of a degree-III furcation involvement.

Amoxicillin↗
PubMed1997

Effect of the NSAID flurbiprofen on remodelling after periodontal surgery.

The aim of the present experiment was to assess the effect of the administration of the NSAID flurbiprofen (Froben) on tissue healing after periodontal surgery. Sites from patients with the same treatment modality (modified Widman flap) but receiving a placebo drug and sites within each patient not exposed to surgery served as controls. Nineteen patients suffering from moderate to severe periodontal disease were recruited and they signed informed consent forms. These patients required periodontal surgery as assessed at the periodontal re-evaluation. The sites chosen for the study were all diagnosed with PPD > or = 5 mm and were bleeding on probing. During the healing phase 10 patients received 50 mg Froben 3 times per day for 30 d whereas 9 patients received a placebo drug. Two sites with PPD > or = 5 mm after initial therapy and bleeding on probing served as surgical sites, whereas 2 similar sites were not exposed to surgery. The study design was set up double-blind. The radiographic examination consisted of 2-4 standardized vertical bitewings obtained at the periodontal re-evaluation (BL) at 1, 3 and 6 months post-surgically for digital subtraction and computer assisted densitometric image analysis (CADIA). The regions of interest analysed were mesial or distal crestal sites. Minimal remodelling activity was observed radiographically after periodontal surgery in both patient groups. There were no statistically significant differences between the four groups of sites regarding the mean changes in density when analysing the pairs of radiographs 0-1, 0-3, 0-6 months. A frequency analysis was performed to list the number of sites with different ranges of density change. No differences in the distributions of the numbers of sites were observed when comparing the 4 site groups (Kolmogorov-Smirnov, p > 0.05). A significant reduction of the probing pocket depth and a significant amount of clinical attachment gain was noted at the surgically treated sites irrespective of whether the patients had used flurbiprofen or placebo. Whereas the pathways leading to bone resorption in periodontally diseased sites have been shown, in other studies, to be influenced by NSAID, the results of the present study could not justify general administration of Froben for the purpose of reduction of bone resorption after periodontal surgical procedures in patients with adult periodontitis.

Absorptiometry, Photon↗