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PubMed1994

What shapes vaccine policy? The case of hepatitis B in the UK.

Comparison of hepatitis B vaccine policy with other cases in the past is complicated by the restricted modes of transmission of this disease, which affects relatively few people in the UK. Still, considerations of cost, fear of contamination, divisions of opinion within the medical profession, and regional dispersal of authority are all factors--analysed for other vaccines--which help to explain the limited UK central policy on hepatitis B immunization observed through the 1980s. An important issue, in previous debates on vaccine policies, has been the conflict between public health interests and the rights of individuals to eschew health interventions imposed by the state. It is argued here that this question fed into hepatitis B vaccine policy in an oblique manner, via policy on screening for hepatitis B in the 1970s; minimal screening mainly of selected groups of health workers was favoured, maximizing individual rights. Changes to hepatitis B vaccine policy can be traced, linked with international policy, pharmaceutical company pressure, advances in vaccine technology, and questions of legal liability. The most accurate predictor for vaccine policy appears to have been screening policy. Will this apply to AIDS, which is epidemiologically similar to hepatitis B?

Health Policy↗
PubMed2006

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

PURPOSE: To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. METHOD: The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. RESULTS: Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant. CONCLUSIONS: Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

Academic Medical Centers↗
PubMed1989

Medical-legal considerations in the postdate pregnancy.

The medical-legal considerations associated with postdate pregnancies are not unlike those associated with the management of an uncomplicated pregnancy. The primary difference is, however, that these pregnancies are at a greater risk of perinatal morbidity and mortality. Therefore, it is important to maintain one's knowledge, understanding, and skills to safely manage these pregnancies and, by so doing, reduce one's medical-legal liability.

Female↗
PubMed1997

Hysterectomy: improving the patient's decision-making process.

Increasingly, patients are expecting to be more involved than they traditionally have been in medical and surgical decision making. The unilateral process of informed consent is evolving into one of informed collaborative choice. Hysterectomy is a procedure that is frequently performed when reasonable surgical and nonsurgical alternatives remain. When professional consensus as to the clear recommendation for hysterectomy is not present, patient choice is particularly important. Because more than 80% of health-care decisions, including those in which one of the choices is hysterectomy, are elective, gynecologists and other health care providers increasingly will need to develop more efficient and collaborative methods to integrate patient autonomy and choice into the decision-making process. There is mounting evidence that both clinical and nonclinical outcomes (satisfaction and cost) may be improved when properly informed consumers collaborate in making medical and surgical decisions. Legal liability for adverse outcomes may be decreased by increased patient participation in medical and surgical decision making. The era of managed care has created an agency problem stemming from the fact that consumers (patients) are concerned that necessary procedures and other treatments may be withheld because of cost considerations. Health plans and medical groups likely will be required to provide objective information about the options that consumers (patients) have when faced with choices, including decision making and hysterectomy. By incorporating patient expectations and preferences as part of the process of decision making, an ethically acceptable and effective method of "rationing by patient choice" may be feasible. Figure 3 is a graphic depiction of such a process of informed collaborative choice progressing from effective choices through efficient choices and then to the one providing the best value for an individual patient.

Cysts↗
PubMedDate not supplied

The impact of the IRB on medical centers.

The role of the IRB in a Medical Center is presented with respect to investigations of medical device safety and effectiveness involving human subjects. The prime points presented and discussed are: the reasons (governmental, social, economic, legal-liability, scientific and moral) for the existence of an IRB; the analytical and descriptive documentation which should always precede experimentation; the concepts governing an application to a "typical" IRB; a practical, detailed outline of some special facts and circumstances typically most important to an IRB; and, the question of confidentiality of trade secrets.

Clinical Trials as Topic↗
PubMed1985

The letter of recommendation.

This month I discuss the dilemma of the department chief who has been asked to write a letter of recommendation for a trainee who has a few deficient areas of endoscopic ability. I emphasize the basic duty of the author to be honest as I describe the contents of the letter. Finally, I discuss the issue of potential legal liability for the author of either a favorable or unfavorable letter.

Clinical Competence↗
PubMed1987

A suicide precautions policy for the general hospital.

Nursing administrators cannot ignore the need for suicide precautions in the general hospital. Though the incidence of suicide might be low, the number of patients at risk remains high. Legal liability for the institution that fails to provide reasonable care can be considerable. The authors offer a model suicide precautions policy, specifically tailored to the general hospital, and describe procedures for its implementation.

Hospitals, General↗
PubMed1994

Substitution laws, insurance coverage, and generic drug use.

This study examined the role of various policies (drug product substitution laws) that are usually motivated by cost containment objectives of insurers in facilitating entry by generic firms. Using data for six Canadian provinces over the years 1981-1988, we evaluated the impact of specific aspects of substitution laws on the level of generic use. We find that formularies and the passage of time are not significant determinants of substitution levels. Legal liability, mandatory product selection, deductible and co-payment schemes, and consumer awareness were found to be important variables. Price responsiveness of generic drugs is indicated but the evidence is not strong.

Canada↗
PubMed1985

Psychology in health risk messages for workers.

The content, style, and mode of company communications directed to workers regarding job hazards and health risks are frequently based only on concerns for technical accuracy and legal liability. These considerations as shaping factors in informational messages do not ensure worker understanding and responsiveness. Moreover, the uncertainty of health threats posed by many workplace chemical and physical agents, and the delayed, insidious disorders they may portend, present formidable obstacles in this regard. This report describes guidelines that attempt to overcome these difficulties, with specific reference to printed forms of informational material. The guidelines are based on concepts from the cognitive and social psychology literature, with additional input from experts in those fields as well as representatives from management and labor who have responsibilities for worker health education in their respective organizations. Selected guidelines are presented and critiques are offered of samples of hazard information materials directed to workers in light of the guidelines' prescriptions. Field trials are planned as a follow-up.

Accident Prevention↗
PubMed2003

A prescription for the rogue doctor: part I--begin with diagnosis.

Among the most serious problems a doctor can have may be those which are the result of a defect of character or a flaw in ethics. Under these circumstances, unacceptable behavior patterns may arise. Examples of unacceptable patterns of behavior include dishonesty, intentionally harming a patient, sexual harassment, and substance abuse. For years, doctors who have these patterns have been handled with kid gloves by those who educate, train, and supervise professionals in the healthcare industry. Counseling, coaching, training, supervising, transfers to less critical disciplines, disciplinary warnings, and offering opportunities to resign have been the typical protocols. Traditionally, outright firing of residents and doctors has been relatively taboo and too radical for the medical profession. Why has this been the case? Reasons may include unwillingness to get involved or to deal with the stress of disciplining a colleague, an unwillingness which often is grounded in fears of retaliation. In a litigious society, fears of slander lawsuits, for example, may be all-too-real. However, the implied paternalism and the practice of protecting doctors' careers by preserving their professional status as practicing doctors have become increasingly problematic. Aside from the fact that it is unethical, allowing problem doctors to continue to practice medicine may have an adverse impact on the well-being of patients and therefore may represent an enormous legal liability for organizations that employ them. In this first of a two-part series, problems that now exist and implementation of a performance management system as a starting point for removing rogues from the system are discussed. A subsequent paper will detail how such a system operates.

Ethics, Medical↗
PubMed2005

Missed expectations? Physicians' views of patients' participation in medical decision-making.

OBJECTIVE: Physicians are encouraged to actively involve patients in clinical decision-making, but this expectation has not been adequately examined from the physicians' perspective. Our objective was to identify and characterize physicians' attitudes toward patient participation in decision-making and to gain insight into how they consequently think about and structure the decision-making process. DESIGN: This was a qualitative cross-sectional study of physicians' reported attitudes and practices. SETTING: The study took place in private practice and academic physicians' practices. PARTICIPANTS: A total of 53 academic and private practice physicians from primary care and surgical specialties, ranging from first year residents to recently retired, participated in the study. MEASUREMENTS: We performed a qualitative analysis of semistructured individual interviews. RESULTS: The physicians in this study expressed consistently positive attitudes toward patient participation in medical decision-making. They identified patient autonomy as an essential justification for patient participation but often went beyond an autonomy-based rationale. Several were motivated by the fundamental principle of beneficence as well as their own self-interest in avoiding legal liability. Many physicians saw their role as an expert who educates the patient but retains control over the decision-making process; others took a more collaborative approach, encouraging patients to assume decisional priority. The decision-making process often was modified by patient, physician, and environmental factors. CONCLUSIONS: The physicians in this study demonstrated a positive, flexible approach toward including patients in decision-making. A one-dimensional model of shared decision-making based solely on the principle of autonomy fails to account for variability in how physicians allocate decisional priority and is therefore ethically inadequate.

Academic Medical Centers↗
PubMed2006

A simple and inexpensive method of preoperative computer imaging for rhinoplasty.

UNLABELLED: GOALS/PURPOSE: Despite concerns of legal liability, preoperative computer imaging has become a popular tool for the plastic surgeon. The ability to project possible surgical outcomes can facilitate communication between the patient and surgeon. It can be an effective tool in the education and training of residents. Unfortunately, these imaging programs are expensive and have a steep learning curve. The purpose of this paper is to present a relatively inexpensive method of preoperative computer imaging with a reasonable learning curve. MATERIALS AND METHODS: The price of currently available imaging programs was acquired through an online search, and inquiries were made to the software distributors. Their prices were compared to Adobe PhotoShop, which has special filters called "liquify" and "photocopy." It was used in the preoperative computer planning of 2 patients who presented for rhinoplasty at our institution. Projected images were created based on harmonious discussions between the patient and physician. Importantly, these images were presented to the patient as potential results, with no guarantees as to actual outcomes. RESULTS: Adobe PhotoShop can be purchased for 900-5800 dollars less than the leading computer imaging software for cosmetic rhinoplasty. Effective projected images were created using the "liquify" and "photocopy" filters in PhotoShop. Both patients had surgical planning and operations based on these images. They were satisfied with the results. CONCLUSIONS: Preoperative computer imaging can be a very effective tool for the plastic surgeon by providing improved physician-patient communication, increased patient confidence, and enhanced surgical planning. Adobe PhotoShop is a relatively inexpensive program that can provide these benefits using only 1 or 2 features.

Adult↗
PubMed2006

Establishing a definition for a nurse-led clinic: structure, process, and outcome.

AIM: This paper reports a study to define a nurse-led clinic by exploring the domains of structure, process and outcome. BACKGROUND: Nurse clinics have been introduced as a measure to support intermediate care after the acute phase of disease. Previous studies have been mainly descriptive, or have only addressed a particular aspect of clinic service. METHODS: This exploratory study was conducted in two phases. In the first phase, nurses from 34 clinics were interviewed. In the second phase, 162 clinic sessions were observed, and 162 patients and 16 physicians were interviewed. The data were collected in 2001-2003. RESULTS: The nurses who ran the clinics were very experienced, and resources were available to support their work. Over 80% of their work was independent or interdependent, involving skills such as adjusting medications, and initiating therapies and diagnostic tests according to protocols. The principal interventions were assessments and evaluations, and health counselling. The nurses rated 'management of symptoms', 'prevention of complications', and 'client satisfaction' as the top three key indicators of their success. All patients studied showed improvement after the nurse clinic consultation, but the best rates were found in wound and continence clinics. Satisfaction scores for both nurses and clients were high. Physicians valued their partnership in care with the nurses, but were concerned about possible legal liability resulting from the advanced roles assumed by these nurses. CONCLUSIONS: A nurse clinic is an effective alternative model of ambulatory healthcare delivery that uses a holistic framework.

Ambulatory Care↗
PubMed2007

Rectal suppository insertion: the reliability of the evidence as a basis for nursing practice.

AIMS AND OBJECTIVES: This paper considers the correct method for inserting a rectal suppository, both as a medication and also to achieve bowel evacuation. The aim is to find out whether the correct method is blunt end or pointed end foremost. BACKGROUND: It follows from a question raised by a third year student nurse. In the classroom, she had been taught that the correct method for the administration of a suppository for systemic absorption was to insert it blunt end foremost into the rectum. However, if the suppository was to be used for evacuant purposes, it should be given pointed end foremost. In clinical practice, however, she was told the suppository should always be inserted pointed end foremost in all cases, whatever the purpose. DESIGN: This article seeks to clarify the dilemma by examining the sources of evidence underpinning different methods for inserting a rectal suppository. Hence, the literature on the insertion of rectal suppositories was gathered as systematically as possible from medical journals and textbooks, nursing journals and textbooks and manufacturers' information to patients. METHOD: Having gathered the literature, this was examined, appraised and critically analysed for rigour, coherence and reliability. RESULTS: The review of the literature appears to show that evidence adduced for inserting the suppository blunt end foremost derives from one study published in the Lancet in 1991, which challenged 'commonsense'. There did not appear to be other, more recent research. On the other hand, manufacturers' information to patients states generally that the suppository should be inserted pointed end foremost. This has direct relevance for the administration of suppositories and also raises questions as to how research may become integrated into healthcare practice without adequate justification. CONCLUSIONS: An article published in the Lancet in 1991 has had a fundamental effect on nursing practice, but has not been subject to scrutiny. The advice given in this Lancet article differs from that currently given by most manufacturers of suppositories, which involves the terms of their product licence. Hence, there is a potential for problems with legal liability should an untoward event arise. RELEVANCE TO CLINICAL PRACTICE: Inserting rectal suppositories, whether as a medication or to achieve bowel evacuation, is a very common healthcare practice. Currently, there is inconsistency and discrepancy in the correct method for this procedure in both nursing education and practice. This paper examines the reliability of existing evidence and shows the need for further work in order to provide a reliable evidence base for this commonplace clinical procedure.

Drug Labeling↗
PubMed2006

Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies.

BACKGROUND: Over the recent years there has been a steady 7% yearly increase in prescribing costs, which accounts for 17% of the Slovene national health care budget. Substitution of branded products by generic equivalents can offer savings. General practitioners (GPs) are often concerned about the quality of generic products and possible legal liabilities associated with their use. OBJECTIVE: We wanted to examine the attitudes of GPs in Slovenia towards generic drug prescribing. METHODS: We conducted a postal survey of a random sample of 200 out of 800 GPs in Slovenia from the National Health Insurance Institute database. GPs were asked 21 questions regarding their knowledge on generic drugs, awareness of prescribing costs, prices of generic drugs relative to brand name drugs and their attitude towards use of generic drugs. RESULTS: The 117 (58.5%) replies we received represent 15% of the GP population in Slovenia. 66.1% of GPs considered rising costs of medicines to be a serious problem for the health care budget. Each week, over 50% of GPs experienced demands from patients for specific drugs and the majority of GPs usually met their patients' demands or requests from hospital consultants for branded products. 38.3% of GPs did not take price into consideration when prescribing drugs. The majority of GPs (88.9%) perceived generics to have the same effectiveness as branded drugs. One quarter of GPs would prescribe more generics if additional clinical trials were presented. 37.3% would follow advice of academic detailers and 30.3% expected the generics to be even cheaper than they were. Independent detailing was welcomed by 63.8% of GPs because of the big influence of the pharmaceutical industry on the prescribing habits. 15.5% thought that the industry had a tremendous impact on their prescribing patterns. CONCLUSIONS: Slovene GPs are aware of the cost of prescribed drugs. They are willing to accept independent academic detailing to improve their prescribing and are willing to increase generic drugs under certain conditions.

Adult↗
PubMed2006

Caesarean section on request: a comparison of obstetricians' attitudes in eight European countries.

OBJECTIVE: To explore the attitudes of obstetricians to perform a caesarean section on maternal request in the absence of medical indication. DESIGN: Cluster sampling cross-sectional survey. SETTING: Neonatal Intensive Care Unit (NICU) associated maternity units in eight European countries. POPULATION: Obstetricians with at least 6 months clinical experience. METHODS: NICU-associated maternity units were chosen by census in Luxembourg, Netherlands and Sweden and by geographically stratified random sampling in France, Germany, Italy, Spain and UK. An anonymous, self-administered questionnaire was used for data collection. MAIN OUTCOME MEASURES: Obstetricians' willingness to perform a caesarean section on maternal request. RESULTS: One hundred and five units and 1,530 obstetricians participated in the study (response rates of 70 and 77%, respectively). Compliance with a hypothetical woman's request for elective caesarean section simply because it was 'her choice' was lowest in Spain (15%), France (19%) and Netherlands (22%); highest in Germany (75%) and UK (79%) and intermediate in the remaining countries. Using weighted multivariate logistic regression, country of practice (P<0.001), fear of litigation (P= 0.004) and working in a university-affiliated hospital (P= 0.001) were associated with physicians' likelihood to agree to patient's request. The subset of female doctors with children was less likely to agree (OR 0.29, 95% CI 0.20-0.42). CONCLUSIONS: The differences in obstetricians' attitudes are not founded on concrete medical evidence. Cultural factors, legal liability and variables linked to the specific perinatal care organisation of the various countries play a role. Greater emphasis should be placed on understanding the motivation, values and fears underlying a woman's request for elective caesarean delivery.

Adult↗
PubMed2001

Anticircumvention rules: threat to science.

Scientists who study encryption or computer security or otherwise reverse engineer technical measures, who make tools enabling them to do this work, and who report the results of their research face new risks of legal liability because of recently adopted rules prohibiting the circumvention of technical measures and manufacture or distribution of circumvention tools. Because all data in digital form can be technically protected, the impact of these rules goes far beyond encryption and computer security research. The scientific community must recognize the harms these rules pose and provide guidance about how to improve the anticircumvention rules.

Computer Security↗
PubMed1998

Some observations on waterslide injuries.

STUDY OBJECTIVE: To investigate the causes of a series of interperson collisions on a waterslide resulting in serious injury, and to assess adequacy of control systems and legal liability. METHOD: Site investigation of operating characteristics including a traffic light controlled system, organisational safety culture, and user behaviour. RESULTS: Despite a battery of safety features including closed circuit TV, citizen's band radios, a traffic light controlled system, part time supervision, and warning notices, the system was found to be inherently "unsafe" as operated. It placed a small but significant percentage of users in a hazardous situation whereby consecutive riders could collide with each other while in the flume even when conforming with all instructions. The realised risk might have been even higher were not staff and users adopting their own precautionary measures. CONCLUSIONS: The risk to waterslide users, even the majority observing the safety rules, was questionably high, and facility operators were vulnerable to a court ruling that they had failed in their duty of care. It is suggested that waterslide operators elsewhere, who are wholly or partially reliant on traffic light controlled systems, should carefully scrutinise the safety of their operating systems. Members of the public who use these facilities would, in any event, be well advised to remain vigilant whatever the perceived adequacy of the safety system in operation.

Adolescent↗