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PubMed2001

Laparoscopic colonic resection.

BACKGROUND AND PURPOSE: In the last decade, laparoscopy has dramatically changed colonic surgery. Laparoscopic procedures are applied to the treatment of almost all colonic diseases, including both benign and malignant lesions. Focusing our attention on the laparoscopic oncologic operative technique, we compared the perioperative results and the long-term outcome of laparoscopic surgery (LS) with those of conventional open surgery (OS) in a series of 360 unselected consecutive patients. PATIENTS AND METHODS: Between 1992 and 2001, excluding 102 patients with rectal tumors, 207 patients underwent laparoscopic colonic resection (72.5% for malignant lesions), whereas 153 (71.9% with malignant lesions) were treated by OS. The treatment modality was selected by the patients after reading the informed consent form. The statistical significance of differences in the morbidity and mortality rates, local recurrence rate, and incidence of distant metastases in the two groups was assessed by chi2 test. The survival probability analysis was performed by the Kaplan-Meier method. Significant differences in survival probability between groups were assessed by the log-rank test. A level of 5% was used as the criterion of statistical significance. RESULTS: Laparoscopic surgery was technically feasible in 95.7% of the patients. No statistically significant difference was observed in the major complication rate (3.5% after LS and 3.3% after OS; P = 0.870) or in perioperative mortality (1.5% v 1.3%; P = 0.769). The mean follow-up in the patients with malignant disease was 42.2 months, during which time, we observed 2 cases of abdominal wall metastases (1.9%) in patients with advanced disease. The local recurrence rate was lower after LS than OS: 2.8% v 8.1%; P = 0.223). Distant metastases occurred in 8.6% of patients after LS and 9.3% after OS (P = 0.926). At 48 months of follow-up, the cumulative survival probability in the LS-completed malignant group was 0.934 compared with 0.860 after OS (P = 0.781). CONCLUSION: Laparoscopic colonic resection for both benign and malignant lesions is technically feasible, without additional risks for the patients. However, oncologic outcomes have not been determined because no data from the ongoing randomized controlled trials are yet available.

Adenocarcinoma↗
PubMedDate not supplied

Practical guidelines for developing an office-based program for outpatient intravenous therapy.

As early discharge from the hospital and initiation of outpatient iv therapy have become more common, physicians have found that although their role as care giver has not diminished, compensation by insurers for that care has. Therefore, physicians may wish to establish their own office-based programs for providing cost-effective, quality care for patients who can be treated on an outpatient basis. Important factors in the establishment of such a program are obtaining the services of a nurse skilled in administration of iv antibiotics and the services of a cooperative pharmacist, utilizing treatment consent forms and instructive handouts for patients, and providing 7-day-per-week nursing care. Physicians must immediately hospitalize program participants who experience complications. To ensure cooperation from third-party payers, familiarity with their codes for procedural terminology is necessary. It is also highly advisable to obtain written approval for a patient's participation in the program from the medical director or another key official of the insurance company.

Ambulatory Care↗
PubMed1986

The practising lawyer's view of in-vitro fertilization.

Legal aspects of the in-vitro fertilization of human eggs are discussed by a practising solicitor involved in opening a private clinic. The nature of legal contracts, research protocols and consent forms for patients are discussed. The rights of the embryo are considered in relation to the patient, freezing and research.

Fertilization in Vitro↗
PubMedDate not supplied

Acceptance of HIV testing during prenatal care. Perinatal Guidelines Evaluation Project.

OBJECTIVE: The purpose of this study was to assess the factors associated with acceptance of HIV testing during pregnancy on the part of women receiving prenatal care at public clinics. METHODS: Trained interviewers recruited and interviewed 1,357 women receiving prenatal care at clinics in Florida, Connecticut, and New York City. RESULTS: Eighty-six percent of participants reported having been tested or having signed a consent form to be tested. Acceptance of testing was found to be related to strong beliefs about the benefits of testing, knowledge about vertical transmission, perceived provider endorsement of testing, and social support. Women who declined testing said they did so because they did not perceive themselves to be at risk for HIV (21%) or they faced administrative difficulties (16%) with some aspect of the testing process (for example, scheduling, limited availability of pre-test counselors). CONCLUSIONS: Acceptance rates can be increased when women understand the modes of vertical transmission and the role of medication regimens in preventing transmission; believe that prenatal identification of HIV can promote the health of mother and child; and perceive their providers as strongly endorsing testing. These points can be woven into a brief pre-test counseling message and made a routine component of prenatal care.

AIDS Serodiagnosis↗
PubMed1994

Reading deficiencies in older patients.

To participate effectively in their health care, older patients often are expected to read a wide variety of materials, including written instructions, brochures, and consent forms. This study quantitates the reading ability of older patients and compares it to that of younger patients. Two hundred seventy-two patients 30 and older were selected from five outpatient clinics at a public teaching hospital and tested for objective reading ability using the Peabody Individual Achievement Test--Revised. The 76 patients 60 and older read significantly worse (grade level 2.9) than the 196 patients younger than 60 (grade level 5.8) (P < 0.0001). Older patients also completed significantly fewer years of school than younger patients (7.3 years versus 10.6 years). Analysis of variance for age categories 30-44, 45-59, 60-74, and 75 and older confirmed declining reading ability and educational status with advancing age. Multiple regression analysis helped show that an equation could be derived to predict reading ability from age, educational status, race, and sex, but the coefficient of determination was so low (r2 = 0.39) that it cannot be considered clinically useful for individual patients. In this study, older patients read significantly worse than younger patients, and a formula that combines age, race, sex, and educational status cannot reliably predict reading ability for individual patients. Most older patients read on a level so low that they cannot be expected to read most commonly used written materials. Routine testing of reading ability may allow more appropriate design and use of written materials.

Adult↗
PubMed1996

Surgical patients' attitudes regarding participation in clinical anesthesia research.

We designed a questionnaire to identify the factors influencing both day of admission surgery (DAS) and ambulatory (AMB) patients in their decision whether to participate in and give informed consent for clinical anesthesia research. On the day of surgery, 276 patients were approached to complete a questionnaire and a visual analog scale (VAS) to assess anxiety. The data collected were observational and are presented as percentages for each group (DAS and AMB). One hundred eighty-two patient (60 DAS and 122 AMB) completed questionnaires. Both DAS and AMB patients desired 20-30 min to read a consent form. Preferred conditions for enrollment by both groups were as follows: interview at the time of preadmission testing; after consulting with their physician; in a private setting while dressed in street clothes; and with assurance that the investigator would also participate in the study, if eligible. Unacceptable conditions were as follows: research associated with any risk and interview in the operating room holding area. All patients responded that they were capable of making the decision whether to participate in research on the day of surgery. Most AMB and DAS patients found it acceptable to be recruited on the day of surgery, if approached appropriately.

Adult↗
PubMed1997

Aesthetic surgical training: the Lenox Hill model.

This program enhances residency training in aesthetic surgery. It provides hands-on operating experience in a supervised hospital setting. Concerns of financial support and liability are addressed. Four chief residents from two university programs each spend 3 months conducting a "private" practice in a service population. A separate resident operative consent form unambiguously specifies the resident as the operating surgeon. Patients are derived from an advertised, free screening clinic every 3 months. The hospital has a special aesthetic surgical fee schedule for the residents. A resident operative fee is collected in support of resident salaries and insurance. An additional fee is collected on behalf of our anesthesiologists. During their 3 months the residents perform 30 to 40 operations as primary surgeon and 50 to 60 as the first assistant. Patient discontent, though rare, is resolved in conference with the patient, the resident, the attending surgeon, and the chief of section. Didactic training consists of monthly surgical conferences, journal club, and guest speaker presentations. Residents experience a practice setting by overseeing appointments to their clinic, booking operating room cases, and providing all paperwork for preadmission testing and certification, as well as fulfilling utilization and quality assurance requirements. They are responsible for their operative patients 24 hours a day, 7 days a week. The program is in its seventh year and its success is noted by continued full certification of the two participating university programs and absence of litigation.

Anesthesiology↗
PubMedDate not supplied

An assessment of social support in people with inflammatory bowel disease.

The purpose of this descriptive study was to assess the perceived level of social support in a sample of people with inflammatory bowel disease. This assessment was to serve as the basis for the development and evaluation of a program of social support. The Personal Resource Questionnaire (PRQ-85), which measures perceived level of social support, was mailed to all members (n = 300) of the Northwestern Society for Intestinal Research. Adults who met the eligibility criteria were invited to participate. Questionnaires and consent forms were completed and returned by 97 subjects. Results indicated that subjects would use a variety of resources if confronted with situations that required social support. The perceived level of social support was high, with mean scores for this inflammatory bowel disease sample reported at 143.86 of a possible 175. A two-tailed t-test suggests there is no significant difference in perceived level of social support between those subjects with Crohn disease and those with ulcerative colitis at the 0.05 level of significance. Because the level of social support was so high in this sample, plans to develop a program of support were abandoned. The meaning of these results including an analysis of the scores and a critique of the questionnaire are discussed.

Adult↗
PubMed2003

The roles and experiences of nonaffiliated and non-scientist members of institutional review boards.

PURPOSE: Little is known about the roles and experiences of non-scientist and nonaffiliated institutional review board (IRB) members (also known as lay members), and what contributions they are making to IRBs. This study investigated the experiences of IRB lay members from leading academic medical institutions in the United States and presents their recommendations for future education and training. METHOD: In 2000, the authors randomly selected and contacted 20 IRBs. From the 11 IRBs that agreed to participate, a total of 32 lay members participated in telephone interviews in which they were asked open-ended questions about the types of initial and ongoing education they had received, their interactions with scientific members, their contributions, the problems they experienced on the IRB, and recommendations for future education and training. RESULTS: Participants believed their role was to represent the community of human subjects, and 94% reported that their main contribution was simplifying the consent forms. Although 94% of participants had positive experiences working with scientist IRB members, 88% occasionally had been intimidated and felt disrespected by them. Forty-seven percent of participants identified lack of education and training as a problem, and 78% wanted more intensive education and training for future non-scientist/nonaffiliated members. CONCLUSION: IRB reform should include better training for non-scientist and nonaffiliated members so that they can take on more active roles. In addition, measures are needed to strengthen the relationships between scientist and non-scientist and nonaffiliated members.

Education↗
PubMed1996

Beta-carotene in HIV infection: an extended evaluation.

OBJECTIVE: Several small short-term intervention studies have suggested that beta-carotene supplementation in HIV-infected patients can increase the number of various immune cells including CD4 cells. This prospective double-blinded study was designed to investigate whether beta-carotene supplementation would result in this immuno-enhancement in a larger number of patients over a longer time period. METHODS: HIV-positive patients were randomly assigned to receive either 60 mg beta-carotene orally three times daily or a matched placebo. In addition, all patients received a multivitamin supplement. Patients were evaluated at baseline, 1 month, and 3 months for T-cell quantitative subsets, natural killer cells, HIV p24 antigen, beta-carotene levels, complete blood counts and chemistry batteries. Body weights and Karnofsky scores were evaluated at each visit. RESULTS: Seventy-two patients signed informed consent forms and entered the study. Except for serum beta-carotene concentration, there were no statistically significant differences (P < 0.05) between the treatment (60 mg beta-carotene three times daily and multivitamins) and placebo (placebo and multivitamins) groups at baseline or after either 1 or 3 months of treatment. DISCUSSION: Earlier studies suggesting that beta-carotene supplementation increased levels of immune cells in HIV-infected patients were not replicated in this study. The addition of a multivitamin supplement to both arms of this study may have masked any difference between the two groups. However, on the basis of the results of this study, we would not recommend supplementation with high doses of beta-carotene for HIV-infected patients.

Administration, Oral↗
PubMedDate not supplied

Patterns of use of complementary therapies among cancer patients and their family caregivers.

Complementary therapies (CTs) are gaining popularity in the general population, including cancer patients, yet little is known about characteristics differentiating the use of one versus more CTs, about the patterns and persistence of CT use over time, or about the characteristics of cancer patients and their family caregivers who elect to participate in a study involving the use of CTs. The focus of this quasi-experimental study was to offer an 8-week, 5-contact, nurse-delivered intervention involving guided imagery, reflexology, and reminiscence therapy to cancer patients undergoing chemotherapy and their family caregivers. Participants were allowed to elect to use none or any combination of CTs. Twenty-seven percent of eligible patients signed consent forms and agreed to participate. The typical participant was Caucasian, married, and had at least a high school education. Higher levels of education predicted use of more than 1 CT among cancer patients; there were no significant predictors for caregivers. Female patients were more likely to complete the CT protocol than their male counterparts, but there were no associations between CT protocol completion and caregiver demographics. Patients and family caregivers who elected to use more than 1 CT did not consistently implement their CTs. Participants who elected to use only 1 CT were more consistently performing their CT over time, suggesting that this lower level of CT use may be easier to integrate into their lives during cancer treatment.

Adult↗
PubMed2001

Former radiation worker Medical Surveillance Program at Rocky Flats.

The United States Department of Energy (DOE), Office of Occupational Medicine and Medical Surveillance, has supported an ongoing Former Radiation Worker Medical Surveillance Program at the DOE Rocky Flats site since 1992. The program currently is managed for DOE by Oak Ridge Institute for Science and Education through a contract with Oak Ridge Associated Universities. Participation in the program is entirely voluntary and provides former Rocky Flats workers who were exposed to radiation with long-term medical monitoring and an update to the assessment of their radiation dose. Program participants receive medical examinations and in vivo and in vitro bioassay measurements of residual radioactivity. Radiation doses to participants are largely a result of internal depositions of plutonium and its radioactive decay products. The causes of many of the higher internal doses were accidents that generally are well documented. Former radiation workers are invited to participate in the program if they meet specific criteria for radiation exposure. Informed consent is documented using a consent form approved by an Institutional Review Board. Demographic, medical, and dosimetric information is maintained in a computer database and will be evaluated for any trends or correlations between exposure and health outcome.

Adult↗
PubMed1994

Clozapine for early developmental delays with childhood-onset schizophrenia: protocol and 15-month outcome.

This paper reports on the pharmacotherapy and long-term follow-up of a child treated with clozapine. It is one of the earliest American experiences with this agent in children to date. Clozapine was relatively effective and safe in this patient. Additional features of the case are the early social and developmental delays preceding schizophrenia, the response of symptoms of childhood-onset schizophrenia to clozapine, and the reduction in tardive dyskinesia symptoms while taking clozapine. Compared to recommendations for dosing adults, a slower rate of increasing clozapine doses was important for this child. For future reference, the protocol and consent form used for this course of treatment are included.

Adolescent↗
PubMed2002

Thalidomide as "salvage" therapy for patients with delayed hypersensitivity response to infliximab: a case series.

Infliximab is efficacious for refractory Crohn's disease, but delayed hypersensitivity reactions preclude retreatment for patients experiencing this complication. We report the results of four patients offered enrollment in an open label trial of thalidomide as "salvage" therapy for their refractory disease. Two patients with active fistulous disease and two with lumenal disease received open-label thalidomide 200 mg every night and were evaluated monthly at the University of Chicago Clinical Research Center for 12 weeks. Before administration, patients signed an informed consent form discussing the potential risks of thalidomide use. Female patients of child-bearing age underwent serum pregnancy testing every 4 weeks. Response was defined as an absolute decrease in Crohn's Disease Activity Index (CDAI) by 100 points or improvement in two of three clinical parameters for fistulous disease. A patient with a single perirectal fistula had complete closure by 4 weeks, the other had noticeable improvement of five perianal fistulae at 4 weeks and complete closure by 12 weeks. One lumenal patient had a CDAI decrease of 250 points in 4 weeks. The fourth patient withdrew secondary to sedation after only a week of therapy. Two patients (one fistula, one lumenal) continued thalidomide past the 3-month study period and remained in remission at 5 and 7 months. Side effects reported were sedation (four of four patients), hypertension (one of four), and peripheral neuropathy (one of four). Thalidomide appears to be a safe and effective alternative for short-term healing in patients who develop infliximab-induced delayed hypersensitivity reaction and may be an alternative strategy for those at risk.

Adult↗
PubMed2002

Measurement of facial muscle strength in normal subjects.

OBJECTIVES: Muscle strength is a fundamental measure of function for neuromuscular systems; however, mimetic facial muscle strength has never been recorded. The objective of the present feasibility project was to measure facial muscle strength. STUDY DESIGN: The study design was a prospective experimental trial in 10 normal subjects. Descriptive statistics, tests, and analysis of variance were used to summarize and compare data. METHODS: Subjects were selected by convenience following submission and approval of a prospectively designed protocol and consent form to the Human Studies Committee. Application of a force transducer to the central eyebrow and commissure during eyebrow raising, eyelid closing, smiling, and puckering was performed by two methods: surface adhesion method (n = 5) and direct probe application method (n = 5). Data were recorded in pounds. Three repetitions of each movement were made. RESULTS: Rank order of muscle strengths (in pounds) by the surface adhesion technique was as follows: brow, 0.758; eye, 0.549; pucker, 0.387; and smile, 0.307. By direct probe application the rank order of muscle strengths was as follows: eye, 0.880; brow, 0.773; and smile, 0.730. CONCLUSIONS: Objective measures of facial motion are crucial for quantitative investigations of preventative, therapeutic, reconstructive, and rehabilitative interventions for facial nerve and muscle lesions. Until the present, objective measures required cross-correlations with current standards that were subjective. This is the first time an actual physical measure of facial muscle function has been performed. The purpose of presenting this preliminary work is to stimulate advancement along this line of research.

Adult↗
PubMedDate not supplied

Impact of cadaveric organ donation on Taiwanese donor families during the first 6 months after donation.

OBJECTIVE: Organ donation is a complex decision for family members of Asian donors. The impact of cadaveric organ donation on both Chinese and Western donor families has not been well investigated within a cultural framework. The purposes of this study were to follow Chinese family members' appraisal of their decision to donate organs, to explore the possible negative and positive impacts of organ donation on their family life, and to determine what help they expected from healthcare providers during the first 6 months after donation. METHODS: Twenty-two family members (10 men and 12 women) of cadaveric organ donors who signed consent forms at an organ transplant medical center in Taiwan participated in this project and completed in-depth interviews during the sixth month after donation. RESULTS: Participants were 25 to 56 years old (mean = 48.15 +/- 8.31 years). The type of kinship of the participants included the donor's parents, older sister, and spouse. Subjects reported several negative impacts: worry about the donor's afterlife (86%), stress due to controversy among family members over the decision to donate (77%), and stress due to others' devaluation of the donation (45%). Positive impacts reported by the subjects included having a sense of reward for helping others (36%), having an increased appreciation of life (32%), having closer family relationships (23%), and planning to shift life goals to the study of medicine (9%). Subjects expected the transplant team to provide information about organ recipients (73%), to submit the necessary documents so that family members could receive healthcare payments from the insurance company (68%), to help resolve legal proceedings and settlements associated with accidents (64%), and to not overly publicize their decision to donate (64%). CONCLUSIONS: Although all of the subjects reported that organ donation was the right decision, the decision to donate did not protect Taiwanese donor families from negative psychocognitive bereavement. The impacts of organ donation were affected by the subject's social cultural, spiritual, and legal context and the nature of their bereavement.

Adaptation, Psychological↗
PubMed2002

Screening women in jails for chlamydial and gonococcal infection using urine tests: feasibility, acceptability, prevalence, and treatment rates.

BACKGROUND: Women entering jails are at high risk for sexually transmitted diseases; however, screening for chlamydial and gonococcal infection is not routinely performed in most jails. New urine tests have made it easier to screen for these infections in nonclinical settings. GOAL: The feasibility and acceptability of urine-based screening for women entering jails and the prevalence of and treatment rates for chlamydial and gonococcal infections were determined. STUDY DESIGN: Women entering jails in Chicago, Illinois; Birmingham, Alabama; and Baltimore, Maryland, who signed consent forms were tested for chlamydial and gonococcal infection by means of the urine ligase chain reaction assay. Those testing positive were treated in jail; health department staff members attempted to contact those already released. RESULTS: Most women who were approached agreed to be tested (range, 87-98%, depending on city), and most of these women provided a specimen (range, 92-100%). Among 5364 women aged 16 to 75 years who were tested, the prevalence of chlamydial and gonococcal infections was high, especially among those <25 years of age (range, 15.3-21.5% for chlamydial infection and 8.2-9.2% for gonorrhea, depending on city). The majority of women testing positive were treated in jail or outside of jail (61-85%). CONCLUSIONS: Screening women in jails for chlamydial and gonococcal infection with urine tests is feasible, is acceptable to most women, and leads to detection and treatment of many infections. Routine screening should reduce medical complications in this population and should prevent transmission in the community, given that many women are soon released.

Adolescent↗
PubMed1991

Patient reading ability: an overlooked problem in health care.

Health care workers often assume that patients who have completed a certain grade in school can read at that level. This study examines the relationships between patient reading ability, the last grade completed, and the reading ability necessary to comprehend commonly used written materials. We tested 528 patients during regular visits to seven outpatient clinics serving a predominantly indigent population. In addition, we analyzed the readability of 280 brochures and consent forms used in these clinics. Most patients had reading abilities on a level far below their last grade completed, while almost all materials tested were written on a level far above average patient reading ability. We conclude that patient reading ability should be routinely tested and that written materials should be developed on a level commensurate with patient reading ability.

Adolescent↗