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Making a difference in the breast implant issue.

The Food and Drug Administration's (FDA's) investigation into the safety of silicone gel-filled breast implants has dominated newspaper, television, and magazine headlines across the country in recent months. ASPRSN member Lynne McCain along with several patients and physicians from the Atlanta, GA area recently had an opportunity to educate lawmakers and staff on the issue of breast implants while on Capitol Hill in October. They later returned to testify before an FDA panel investigating the issue and played a key role in the panel's November decision to recommend keeping the implants on the market until further research was available on the safety of the implants. The following article details the group's efforts with lawmakers in October and before FDA panel members in November, and demonstrates that nurses and patients can make a difference!

Expert Testimony↗

Developing a performance improvement program.

In today's health care environment, the focus has shifted to quality in every aspect of patient care, with this emphasis coming from patients, employers, insurance companies, and regulatory and accreditation agencies. Developing a performance improvement (PI) program to document quality of care can promote a safe environment and improve patient outcomes. There are helpful resources such as the Web, books, magazines, and continuing education resources that can provide structure and guide in the development of the PI program.

Ambulatory Surgical Procedures↗

The image of plastic surgeons in news media coverage of the silicone breast implant controversy.

We analyzed the portrayal of plastic surgeons in the media by using the qualitative method of narrative analysis of newspaper articles available between July 1991 and June 1992 and popular magazine articles available from 1965 through 1992 in the Tampa Bay area. Plastic surgeons were presented as antagonists in the "horror stories" of sick women, as combatants in a medical community divided in its assessment of health risks, and as profit-oriented businesspersons. Patients were fully developed heroines, whereas plastic surgeons were described negatively by their antagonists, which undermines the expertise, good character, and good will that determine credibility for plastic surgeons. Providing the press with stories about their own efforts to help patients might have helped plastic surgeons receive more favorable press and enhance their credibility. More sophisticated handling of underlying values and the problem of communicating safety also might have been helpful.

Breast Implants↗

An Internet-based utility assessment of breast hypertrophy.

The Internet has changed the way people shop, do business, and communicate with one another. Even those who try to avoid computers are bombarded with Web advertisements on television and in newspapers and magazines. The Internet also has excellent, but still largely underused, potential for conducting research studies. A Web-based questionnaire essentially combines the power and graphic flexibility of a computer with the freedom of a mail survey. The specific goals of this study were (1) to develop a Web-based utility assessment tool and (2) to use this tool to measure the health burden of breast hypertrophy by using the Internet to sample a population. An open-enrollment, Internet-based survey was developed to assess societal preferences for mild and severe breast hypertrophy using three established assessment techniques: visual analogue scale, time trade-off, and standard gamble. Subjects were recruited from a Web-based clinical trial listing service. Demographics, subjects' utility for their current health, and responses to a comorbidity index were also recorded. Data were recorded from August 1, 1999, to January 31, 2000. There were 480 unique responses, and 356 (74 percent) met the inclusion criteria. The respondents were predominantly female (81 percent), Caucasian (83 percent), and in the middle income brackets. Their mean age was 32.9. The average score for capacity of understanding was 4.99 out of 5 (5 = excellent). The median utility score for severe breast hypertrophy (visual analogue scale, 0.70; time trade-off, 0.85; standard gamble, 0.88) differed significantly from the median utility score for mild breast hypertrophy (visual analogue scale, 0.93; time trade-off, 1.0; standard gamble, 0.98) for each method. The results showed that the construction of a Web-based questionnaire for utility assessment is feasible and can be used to capture the utility of health states. The authors were able to enroll a large number of subjects with excellent capacity to understand the study, resulting in a high rate of usable responses. The applicability of these data to cost-effectiveness studies is limited by the extent to which the sampled population of this study is representative of society in general. The demographics of this study sample also differed from those of the Internet population. The study was piloted by measuring the values for breast hypertrophy, but the procedure could be used to assess the burden on quality of life of any disease and, potentially, the efficacy of surgical interventions. The study method is recommended as an accurate and cost-effective alternative for measuring quality of life.

Adult↗

An analysis of telephone interview data collected in 1992 from 820 women who reported problems with their breast implants to the food and drug administration.

How health care providers deal with concerns and feelings of women who have problems with their breast implants affects the women's satisfaction with their breast implants, yet in 1992 little was known about the concerns and feelings of these women. A qualitative analysis of in-depth telephone interviews conducted in 1992 with 820 women from all regions of the United States who reported problems with their breast implants to the Food and Drug Administration and responded to an invitation to be interviewed provided data. Respondents were primarily 40 to 69 years of age at the time of interview, Caucasian, married, and educated beyond high school. The sample was almost equally divided in reason for breast implants, with 65 percent being dissatisfied with their breast implants. Nearly all of the women had heard of problems with silicone gel-filled implants. Their main sources of information were television, newspapers, and magazines rather than their physicians or the breast implant manufacturers. Some women tried to avoid hearing the reports, and many tried to put the reported problems out of their minds. However, a majority (88.7 percent) wanted more information. The women expressed feelings of anger, regret, and worry, and repeatedly said they needed more information. Women who contacted the Food and Drug Administration about breast implant problems needed accurate and honest information from health care professionals. They wanted their physicians to explore their symptoms, fears, and concerns.

Adult↗

Delay in the diagnosis of cutaneous melanoma: an analysis of 233 patients.

Knowledge of factors associated with the detection of cutaneous malignant melanomas and reasons for delay in diagnosis are essential for the improvement of secondary prevention of cutaneous melanoma. For this reason, the extent and consequence of patient and professional delay in diagnosis and treatment was investigated in 233 patients with histologically proven primary cutaneous melanomas seen at the Department of Dermatology and Allergology at the Ludwig-Maximilians-University, Munich, Germany, between January 1999 and January 2001. Personal interviews were conducted by two physicians to obtain information on patients' knowledge of melanoma symptoms, sun behaviour, delay in seeking medical attention, professional delay and related factors. The main component of delay was patient related. Nearly one-third (29.2%) of all patients reported a delay interval of more than 12 months from the onset of an observed change in a pigmented lesion or first detection of a pigmented lesion to the first visit to a physician. The delay interval from the first visit to a physician to surgical treatment was shorter (< 1 month) in most of our patients (74.7%). The predominant symptoms of melanoma detected by patients were a change in colour and an increase in size or elevation. Most patients had obtained knowledge about cutaneous melanomas from television and magazines. A delay in diagnosis and a history of many sunburns and outdoor leisure time activities were not associated with a greater tumour thickness. However, fairer skin types, lower education levels and lack of knowledge about cutaneous melanoma were associated with a greater tumour thickness. Further efforts are necessary to improve public and medical education about early detection and prompt surgical treatment, which is known to be the most effective treatment modality for cutaneous melanomas.

Adult↗

Interruption to research design: substance driven research.

When adolescent women, readers of YM, Seventeen, and Teen, met individually and in a series of four or five focus group meetings to talk about the health messages in teen magazines, their surprising responses did not fit the feminist, critical theory, and media reception analysis methods used to guide the study. The undisputed acceptance of research methods as the sole means to knowledge and truth was interrupted by the voices of the adolescents that resisted methodological codification. Hermeneutics or interpretive inquiry transformed my study to one that became substantively driven and contributes to the qualitative approaches in the human sciences.

Adolescent↗

Women's beliefs about "natural" hormones and natural hormone replacement therapy.

OBJECTIVE: To assess women's beliefs about natural hormones, including what they believe the term "natural" means, and their beliefs about the risks, side effects, and efficacy of natural hormone replacement compared to standard hormone replacement. DESIGN: Eighty-two women completed a 20-item survey available at a local compounding pharmacy. Respondents were white (100%), middle-aged (mean age, 47.22 years), and college educated (95.1%); 32.9% were perimenopausal, and 50.0% were postmenopausal; 58.5% were currently using hormone replacement therapy and, of those, 77.1% were using human bio-identical hormones. RESULTS: Ninety percent of the respondents ( n = 74) reported that they had heard about natural hormones. Of those, most believed natural meant plant-derived (44.6%) and/or not synthesized or made without chemicals (50.0%). Most reported hearing about natural hormones from a healthcare provider (66.2%) and/or magazines and books (55.4%). When compared with standard hormone replacement, most respondents endorsed the beliefs that natural hormones have fewer or no risks (71.4%), have fewer or no side effects (69.0%), and are equally or more effective for managing menopause symptoms (61.8%). In addition, many endorsed the beliefs that natural hormone replacement is equally or more effective than standard hormone replacement for protection against osteoporosis (47.1%) and heart disease (40.0%), although many endorsed "don't know" for bone (45.7%) and heart (54.3%) protection. CONCLUSIONS: Among women responding to a survey in a compounding pharmacy, most believed that, compared with standard hormones, natural hormones are safer, cause fewer side effects, and are equally or more effective for symptom management. Many believed natural hormone replacement is equally or more effective for long-term bone and heart protection. Educating women on the nature, risks, and benefits of natural hormone therapy is recommended.

Adult↗

The phakic intraocular lens implant: in-depth focus on posterior chamber phakic IOLs.

Phakic Intraocular surgery has come a long way in the past 20 years, especially in the evolution of posterior chamber phakic intraocular lenses (PC PIOLs). Clinical trials worldwide are showing acceptable results concerning efficacy, predictability, stability, and safety. PC PIOLS are proving to be a promising option for patients with high and extreme ametropia who cannot benefit from conventional corneal refractive procedures. This article provides an in-depth examination of PC PIOLs, their origin and evolution, and the results of past and current clinical studies. Reports of historical importance and studies published since the 1990s in peer-reviewed journals, textbooks, and monthly eye magazines, as well as Food and Drug Administration preliminary clinical findings, are reviewed. Anterior chamber phakic intraocular lenses are mentioned briefly.

Humans↗

Effects of animal-assisted therapy on patients' anxiety, fear, and depression before ECT.

OBJECTIVE: To determine whether animal-assisted therapy (AAT) is associated with reductions in fear, anxiety, and depression in psychiatric patients before electroconvulsive therapy (ECT). MATERIALS AND METHODS: Before their scheduled ECT treatment, 35 patients were assigned on alternate days to the treatment condition, consisting of a 15-minute AAT session, and the standard (comparison) condition, consisting of 15 minutes with magazines. Visual analogue scales were used to measure anxiety, fear, and depression before and after treatment and standard conditions. RESULTS: The effect of AAT on fear was significant in both the mixed-model, repeated-measures analysis of covariance (ANCOVA) (p = 0.0006) and the secondary analysis (p = 0.0050), which covaried out all of the demographic conditions (gender, race, marital status, pet ownership, age), condition order, and the pretest rating. The effect of AAT on anxiety approached significance in the ANCOVA (p = 0.0982), but in the secondary analysis, the effect was not significant (p = 0.6498). The AAT effect on depression was not significant in ANCOVA (p = 0.7665) or in the secondary analysis (p = 0.9394). A least squares mean analysis showed that AAT reduced fear by 37% and anxiety by 18%. There was no demonstrated effect of AAT on depression. CONCLUSIONS: Animal-assisted therapy may have a useful role in psychiatric and medical therapies in which the therapeutic procedure is inherently fear-inducing or has a negative societal perception.

Adult↗

The artificial tympanic membrane (1840-1910): from brilliant innovation to quack device.

OBJECTIVE: To present the rich and checkered history of the artificial eardrum, a widely used device in the 19th century, and to illustrate the behavior of otologists in response to the introduction of a promising new technology. DATA SOURCES: Over 40 published books and articles spanning the years 1821 to 1909 in English, German, and French. DEVICE DESCRIPTIONS: A wide variety of devices were used to improve hearing and, purportedly, to reduce aural discharge. The most popular devices were made of gutta percha attached to a silver wire stem (Toynbee) and cotton balls with extraction cords (Yearsley). Other membranes included India rubber, lint, tin or silver foil, and even the vitelline membrane of an egg. Adhesion to the drum remnant was with saliva, water, petroleum jelly (Vaseline), or glycerin. Some were applied by the physician, whereas others were inserted daily by the patient, much as contact lenses are today. CONCLUSIONS: In several cases, the method of positioning an object over the drum remnant was actually invented by clever patients and then later adopted by practitioners. Once introduced, great optimism was generated about the "miraculous" value of this deafness cure. Petty jealousy among early inventors led to very public (and unprofessional) quarrels over the primacy of invention and bickering about whose device was superior. Over the subsequent decades, as more experience demonstrated the device's limited value, enthusiasm waned until otologists largely abandoned these devices around the turn of the last century. In the first two decades of the 20th century, artificial eardrums reached their peak of fame among the public when they were enthusiastically (and dishonestly) marketed by numerous quacks through newspaper advertisements as a universal cure for all forms of deafness. Only with the coming of the Food and Drug Administration did advertisements for US dollars 5 mail-order, medicated eardrums disappear from popular newspapers and magazines.

Advertising↗

Pavlovian conditioning with ethanol: sign-tracking (autoshaping), conditioned incentive, and ethanol self-administration.

BACKGROUND: Conditioned incentive theories of addictive behavior propose that cues signaling a drug's reinforcing effects activate a central motivational state. Incentive motivation enhances drug-taking and drug-seeking behavior. We investigated the behavioral response to cues associated with ethanol and their interaction with operant self-administration of ethanol. METHODS: In two experiments, rats received operant training to press a lever for a sweetened ethanol solution. After operant training, the animals were given Pavlovian pairings of a brief and localized cue light with the sweetened ethanol solution (no lever present). Lever pressing for ethanol was then re-established, and the behavioral effects of the cue light were tested during an ethanol self-administration session. RESULTS: The conditioned responses resulting from pairing cue lights with the opportunity to ingest ethanol had three main effects: (1) induction of operant behavior reinforced by ethanol, (2) stimulation of ethanol-seeking behavior (magazine entries), and (3) signal-directed behavior (i.e., autoshaping, or sign-tracking). Signal-directed behavior interacted with the other two effects in a manner predicted by the location of the cue light. These conditioned responses interact with operant responding for ethanol reinforcement. CONCLUSIONS: These findings demonstrate the importance of Pavlovian conditioning effects on ethanol self-administration and are consistent with conditioned incentive theories of addictive behavior.

Animals↗

Perceptions of genetic discrimination among at-risk relatives of colorectal cancer patients.

PURPOSE: To explore the concerns of at-risk relatives of colorectal cancer patients about genetic discrimination and their awareness of current legislative protections. METHODS: A questionnaire was sent to unaffected individuals with a family history of colorectal cancer who had enrolled in the Johns Hopkins Hereditary Colorectal Cancer Registry (N = 777). RESULTS: Of the 470 respondents, approximately half rated their level of concern about genetic discrimination as high. The majority of respondents, 79%, learned about genetic discrimination from at least one media source (television, newspapers, magazines, and radio). If they were to pursue genetic testing, respondents with a higher level of concern about genetic discrimination would be significantly more likely to pay out of pocket, use an alias, or ask for test results to be excluded from their medical record. Awareness and understanding of legislation regarding genetic discrimination was found to be minimal. CONCLUSION: Findings from this study demonstrate the negative effect of concerns about genetic discrimination on decisions about utilization of genetic services. Stronger legislative protections against genetic discrimination and increased public education through the scientific community and media sources are needed.

Adult↗

A survey on patient educational needs in irritable bowel syndrome and attitudes toward participation in clinical research.

BACKGROUND: The educational needs of patients with irritable bowel syndrome (IBS) are poorly understood and rarely studied. AIM: To determine the educational needs of IBS patients, regarding content, presentation format, and expectations from healthcare providers. METHODS: Fifteen functional GI clinic patients were asked open-ended questions to generate items for a questionnaire addressing the study aim. A total of 104 IBS patients received this questionnaire by mail (42 had declined to participate in a prior IBS study). To assess the frequency of endorsements and importance (on a scale of 1-3) of the items, an index was calculated (frequency of endorsements x mean rating per item, first priority scored 3, third priority scored 1). A higher index indicated greater endorsement based on frequency and rating of response. RESULTS: A total of 29 (28%) subjects (22 willing, 7 unwilling to participate previously in questionnaire research) completed the questionnaire (mean age, 42.6 years; SD, 14.2 years; 19 female, 10 male). The overall low response rate is likely related to the population studied; 40.4% of our study subjects have declined participation in prior research. The response rate of those who have previously agreed to participate was 36%. The typical response profile included: interest in learning disease management (index=1.4) and preference for information presented in person by an M.D. (2.4). Choice of presentation media included magazines (1.9), television (1.5), and Web sites (1.2). Doctors' qualities ranked high related to competency (0.8), allocation of sufficient time (0.7), and listening skills (0.4). Preferred incentives for research participation included a thank you note (0.4), summary of trial results (0.3), and monetary incentives (0.6). CONCLUSIONS: This qualitative study will provide pilot data for a national survey on the educational needs of IBS patients, for use in developing effective patient-centered, educational programs.

Adult↗

The Italian STD 'Hot-Line'. Making people aware.

BACKGROUND: To increase the accessibility of qualified and anonymous information on sexually transmitted diseases (STDs) in Italy, a national telephone hotline was initiated in February 1997. GOAL: The goal was to determine the profile of callers to the national STD hotline, assess their concerns, identify their sources for the hotline telephone number, and to compare callers' disease interests with diagnoses made at STD clinics. STUDY DESIGN: The survey analyzed 3577 calls received from February 1997 to December 1999. Hotline operators addressed callers' questions, asked 6 short-answer questions, and recorded the data collected. RESULTS: The survey showed callers' sex distribution (49.8% women, 50.2% men), average age (women's mean+/-standard deviation [SD], 34.3 +/- 11.8 y; men's mean +/- SD, 36.2 +/- 12.2 y), level of education (66.4% had a secondary school degree), residence (47.9% northern part of Italy), risk category (44% reported being definitely infected by a STD), specific disease interest (30% were concerned about HIV), and source of hotline telephone number (67.3% learned the hotline telephone number from magazines or newspapers). Hotline callers' specific disease interests were compared with diagnoses made at STD clinics; the top 4 disease concerns of hotline callers were HIV, genital herpes, human papillomavirus/genital warts, and mycosis, whereas the top 4 diagnoses made at STD clinics were genital warts, nonspecific vaginitis, nonspecific urethritis, and genital herpes. CONCLUSION: The hotline seems to be an effective way to deliver information and to allay fears about STDs, although it needs to be promoted more widely, especially in central and southern Italy.

Adult↗

The positive effect of targeted marketing on an existing uterine fibroid embolization practice.

PURPOSE: Although uterine fibroid embolization is an effective treatment option for symptomatic women, it is unclear what methods can be used to expand referrals in an already established practice. The authors tested the hypothesis that an advertising strategy focused on a defined target market can expand an existing uterine fibroid embolization practice. MATERIALS AND METHODS: A market-driven planning sequence was employed. This included a determination of goals, an examination of current competition, determination of target market based on local environment and previous consumer use, pretest of product sample, and implementation of advertisement. Based on the analysis the authors determined that the target audience was professional black women aged 35 to 45. A specific weekly magazine was selected due to readership demographics. An advertisement was run for 8 consecutive weeks. The authors prospectively tracked patient inquiries, clinic visits, cases performed, and revenues generated for 3 months following the initial advertisement. All patients were seen in a fully staffed, preexisting fibroid clinic located within an urban, university-based academic practice performing 250 uterine fibroid embolizations annually. RESULTS: Ninety calls were received directly related to the advertisement. There were 35 clinic visits, which resulted in 17 uterine fibroid embolizations and 52 total MR imaging procedures. Eighteen patients were not considered candidates based on established protocols. The 17 extra cases performed over 3 months represented a 27% increase in case volume. Total professional cash collections for these cases (including MR imaging) were 58,317 US dollars. The cost of advertising was 8,000 US dollars. As a result of existing infrastructure, no additional costs were necessary. This resulted in a net revenue gain 50,317 US dollars and a nonannualized rate of return of approximately 625%. CONCLUSION: As Interventional Radiologists look to develop and expand existing practices, traditional marketing tools such as those utilized in this study can be used to facilitate practice growth for specific clinical programs, such as uterine artery embolization. Defining a target market can significantly expand an existing uterine fibroid embolization practice. The optimal choice of targeted media awaits verification from future studies.

Adult↗

Attitudes of adolescents about cosmetic surgery.

Although the number of teenagers choosing to have cosmetic procedures is increasing at a rapid rate, few studies have been published describing their attitudes about aesthetic surgery. To understand better their beliefs about cosmetic surgery, voluntary, confidential surveys were sent to the entire junior class of a suburban high school. Although two thirds of the respondents knew someone who had undergone cosmetic surgery, only one third would choose it for themselves. Those who desired aesthetic surgery described people who have cosmetic procedures as "motivated," whereas those who would not choose this option believed individuals who do so are "vain." The most desired procedures were liposuction, rhinoplasty, and breast augmentation. The main reasons for not proceeding were health risks, cost, and fear of a bad result. The most common source of information about plastic surgery among the students was teen magazines and television.

Adolescent↗

Great shakes: famous people with Parkinson disease.

James Parkinson is credited with the first complete clinical description of the syndrome attributed to his name, Parkinson disease. It is recognized as the first syndrome defined after neurology became a specialty. Descriptions of Parkinson features are rare in antiquity, and famous people with this disorder have not been found before the 1800s. During the 20th century, more and more famous people appear to be afflicted with Parkinson, and this article reviews some of those who have withstood the "test of Time magazine," and examines some of the reasons why the syndrome is a relatively recent disorder.

China↗