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Surgical decision-making: integrating evidence, inference, and experience.

Evidence-based medicine provides a well-developed framework for evaluation of clinical research. Well-designed and adequately powered randomized controlled trials provide the best information on therapeutic efficacy; however, extrapolation of the trials' conclusions to individual patients may be difficult, and for many important surgical problems, trial data are unavailable. A complementary approach of inferential decision-making helps address these limitations, and increases the clinician's confidence in the safety of an approach of unknown efficacy. Experience establishes norms and expectations, and emphasizes events that are uncommon but clinically important. Although it cannot eliminate uncertainty or controversy, the integration of analytic techniques of evidence, inference, and experience provides the surgeon with the best means of adapting treatment to the unique circumstances of the individual patient.

Clinical Competence↗

The legal landscape at the threshold of viability for extremely premature infants: a nursing perspective, part II.

This is the second of a 2-part article exploring the legal landscape overlying the difficult decisions that can confront a family with an extremely premature infant at the threshold of viability. In Part I, recent legal regulations and litigation were analyzed to show that the baby doe regulations are largely inert and that recent litigation arises out of state laws and regulations. Part II takes up the analysis to show that the common thread through all these conflicts, and the subsequent litigation, is a failure to obtain parental consent for the course of treatment at issue. The author argues that the central focus of all parties seeking to minimize legal risks in these situations must be on creating a transparent decision-making process that includes the parents from the onset. Nurses play a pivotal role in that process and are supported broadly by the professional guidelines of the American Nurses Association, the Association of Women's Health Obstetric and Neonatal Nurses, the National Association of Neonatal Nurses, the American Academy of Pediatrics, and the Principles of Family-Centered Neonatal Care.

Fetal Viability↗

Cost containment: strategies and responsibilities of the laboratory manager.

In these difficult times we must not lose the sense of purpose and the personal drive that makes it possible to achieve excellence. We can be exasperated with reduced funding, burdened with excuses, debilitated with confusion about budgetary cuts, and even be stubborn about alternatives, but we must be serious about excellence and quality. It is natural that during these times we will face those with conflicting views, negative ideas, and erratic long-term goals, but that in itself should rouse us, as professionals, toward the pursuit of quality health care services. With better scheduling of tests and procedure, improved discharge planning, more careful review of the need for patient hospitalization, and a more careful examination of the number, mix, and quality of services furnished during a patient's hospital stay, we, as a health care team, can and will reduce unnecessary utilization of all services. Well-managed laboratories must operate around a return on investment threshold, from which all products, services, and expenditures are ranked. On this basis, management decisions will be made to add to service, reduce service, improve or sustain quality, change technology, or discontinue the business altogether. Given the mandate embodied in the DRG regulations, laboratories have become cost centers. New ideas, new technology, and creative efforts must now be used to improve laboratory productivity while sustaining quality health care services. It is argued philosophically that the DRGs or other major measures to reduce funding adversely affect quality of service. This may be true under the traditional definition of services, but there must be "a new order of things." Today's complex problems indicate that orthodox solutions no longer apply, and in our quest to answer who should pay versus who should receive, and how much is enough, we must ensure quality of all services offered. This new order of doing things could result in far greater savings than has previously been predicted. The patient's length of stay in the hospital has already been reduced. There will continue to be decreases in laboratory utilization and consumption of resources necessary to provide laboratory services. Cost competitiveness coupled with the laboratory's need for increased productivity will further expand savings. To summarize, the laboratory manager in the mid-1980's will have the following goals. To provide quality, cost-efficient, and timely laboratory services. To sustain and nurture the growth of the clinical laboratory profession as dictated by the needs of society and new scientific trends and discoveries.(ABSTRACT TRUNCATED AT 400 WORDS)

Cost Control↗

The "gag rule" revisited: physicians as abortion gatekeepers.

In this article, I explore this failure [of the therapeutic exception as a compromise device in federal abortion counseling regulations] with an eye toward its broader lessons about the social uses of medical discretion and the difficulty of achieving an abortion compromise in America. I begin by examining the legal underpinning beneath the widespread belief that the "gag rule" imposed a near-absolute ban on discussion of the abortion option. This conventional wisdom, I conclude, collapses on careful inspection. It fails utterly to account for the strong support to be found in the Title X regulations and their larger legal context for a therapeutic exception unconstrained by administrative or judicial definition. Next, I observe that this legal unboundedness would have empowered Title X clinic physicians (and perhaps others who do counseling) to exercise broad discretion over abortion access, under the rubric of medical indication.... By so doing, however, physicians would have become abortion gatekeepers. This would have raised difficult ethical and clinical questions about the extent to which medical judgment should be allowed to incorporate (and shield) socially-disputed moral choices. I briefly consider some of these questions, along with the countervailing appeal of preserving a measure of intimate freedom under medical cover. I then conclude by positing some connections between the moral infirmities of medical gatekeeping and the political failure of the therapeutic exception. I suggest, in essence, that this failure was ensured by a strong resonance between the exception's moral infirmities and the fears of the medical leaders, pro-choice activists, and abortion opponents who framed the public debate over the "gag rule." The potential breadth of the therapeutic exception went unrecognized and unexplored because professional and popular understanding of the abortion counseling regulations was molded by the activists who framed the debate...

Abortion, Induced↗

[The UV record. Document for quality control, therapy planning and risk assessment in dermatologic photo- and photochemotherapy].

Ultraviolet (UV-) radiation therapy as a mono- or combination therapy (UV-A, UV-A1, UV-B, SUP, UV-B311) or as photochemotherapy with photosensitization (systemic PUVA-, bath PUVA-, topical PUVA-therapy) are successfully used for the treatment of several dermatological disorders. Long-term side effects of natural UV (sun light) include photoaging and induction of skin tumors. At present, the relevance of in-vitro findings of potential tumor induction in animals through therapeutic levels of UV radiation is a matter of debate. To assess these risks, information on treated location, kind of UV radiation and cumulative UV doses are required. Practically this information is barely accessible. This makes decisions on possible therapies difficult. To solve this problem we propose to use an "UV pass". At the end of each UV radiation cycle, the body location, the type of radiation and the cumulative dose are documented and this pass is given to the patient. This will improve the information transfer if the doctor is changed, as well as facilitating decisions about certain therapies and calculation of long-term risks of UV radiation. Finally it will improve the quality of UV photo- and photochemotherapy.

Dose-Response Relationship, Radiation↗

Validation of a decisional conflict scale.

The study objective was to evaluate the psychometric properties of a decisional conflict scale (DCS) that elicits: 1) health-care consumers' uncertainty in making a health-related decision; 2) the factors contributing to the uncertainty; and 3) health-care consumers' perceived effective decision making. The DCS was developed in response to the lack of instruments available to evaluate health-care-consumer decision aids and to tailor decision-supporting interventions to particular consumer needs. The scale was evaluated with 909 individuals deciding about influenza immunization or breast cancer screening. A subsample of respondents was retested two weeks later. The test-retest reliability coefficient was 0.81. Internal consistency coefficients ranged from 0.78 to 0.92. The DCS discriminated significantly (p < 0.0002) between those who had strong intentions either to accept or to decline invitations to receive influenza vaccine or breast cancer screening and those whose intentions were uncertain. The scale also discriminated significantly (p < 0.0002) between those who accepted or rejected immunization and those who delayed their decisions to be immunized. There was a weak inverse correlation (r = -0.16, p < 0.05) between the DCS and knowledge test scores. The psychometric properties of the scale are acceptable. It is feasible and easy to administer. Evaluations of responsiveness to change and validation with more difficult decisions are warranted.

Aged↗

Women's understanding of abnormal cervical smear test results: a qualitative interview study.

OBJECTIVE: To describe how women interpret their experiences of diagnosis and treatment of a cervical abnormality and how healthcare services for such women can be improved. DESIGN: Qualitative study using detailed individual interviews. SETTING: Australian gynaecology clinics. SUBJECTS: 29 Women who had a cervical cytological abnormality and who attended a gynaecologist. MAIN OUTCOME MEASURES: Women's views on their diagnosis and their information needs. RESULTS: Most women wanted to participate in decisions about their care but found it difficult to get the information they required from doctors because they were confused by what their doctors told them and felt unable to ask questions in the consultation. Medical terms such as wart virus and precancer were difficult to understand. Not being able to see their cervix also made it hard for women to understand what their abnormality meant and what treatment entailed. Most women tried to make sense of their abnormality in the context of their everyday lives. For some women their gynaecological care was not consistent with the way they understood their abnormality. CONCLUSIONS: The inherent power structure of medical practice combined with time pressures often make it difficult for doctors to give the detailed information and reassurance patients need when a diagnosis is distressing or when investigation and treatment are strange and upsetting.

Adolescent↗

The medical provision of hydration and nutrition: two very different outcomes in Victoria and Florida.

Decisions to withhold or withdraw medical hydration and nutrition are amongst the most difficult that confront patients and their families, medical and other health professionals all over the world. This article discusses two cases relating to lawful withdrawal and withholding of a percutaneous endoscopic gastrostomy tube (PEG) from incompetent patients with no hope of recovery. Victoria and Florida have statutory frameworks that provide for advance directives, however in both Gardner; Re BWV and Schindler v Schiavo; Re Schiavo the respective patients did not leave documented instructions. The article analyses the two cases and their outcomes from legal, medical and ethical perspectives.

Adult↗

Issues of medical necessity: a medical director's guide to good faith adjudication.

The term medical necessity is difficult to define, a problem for insurers who need to clearly describe what is and is not covered in their contracts with subscribers. An unclear, vague definition of medical necessity leaves insurers vulnerable to litigation by subscribers denied care deemed medically unnecessary. To avoid lawsuits, insurers must make every effort to educate their subscribers about their medical coverage, going beyond merely providing a lengthy subscriber handbook. In decisions on medical necessity, medical directors at insurance companies play a key role. They can bolster the insurer's position in denial-of-care cases in numerous ways, including keeping meticulous records, eliminating unreasonable financial incentives, maintaining a claims denial database, and consulting with other insurers to achieve a consensus on medical necessity.

Decision Making, Organizational↗

The very elderly dialysis patient: indication and discontinuation of dialysis.

1. When the current available data in the literature is summarized it becomes evident that the majority of it supports the position that it is, at least for medical reasons, not advisable to exclude patients over the age of 80 years from chronic dialysis. 2. It is correct to say that the refusal of dialysis therapy for elderly dialysis patients would lead to a not insignificant cutting of costs, although elderly patients are not as 'expensive' as younger dialysis patients. 3. The decision to exclude patients over 80 from dialysis treatment is difficult, in our opinion, to support ethically. 4. The refusal of therapy by a dialysis patient--independent of his age--can only occur with his/her consent, as long as the patient is clearly conscious of the decision. 5. Should the patient no longer be in the condition to exercise his/her autonomy, and there is no AD, the Surrogate's Court must be consulted. 6. AD can be seen as helpful, since they not only make the decisions for physicians easier, but also because they can be seen as an act of care for family members. 7. Whenever dialysis therapy is discontinued the problematic nature of so-called essential care should be carefully considered, especially if no clear position has been taken in an AD.

Advance Directives↗

How should effectiveness of risk communication to aid patients' decisions be judged? A review of the literature.

Risk-communication interventions are associated with benefits at both the individual and the public health level. However, the types of outcomes used to assess the effectiveness of risk-communication interventions vary greatly. This makes synthesis of the research in systematic review difficult, and limits both the implementation of advances in clinical practice and further research. This article reviews the outcomes used in risk-communication publications, particularly those addressing individual decisions about treatment. From the traditional cognitive and behavioral research outcomes of patient knowledge, risk perception, and compliance, the emphasis has shifted towards more affective outcomes, including satisfaction, assessment of the information provided and the decision-making process, and certainty about whether the best option has been chosen. These affective outcomes may be more specific and sensitive measures for risk-communication research. Further development and validation of measurement scales to address these issues is needed.

Communication↗

Towards a family approach in a psychiatric day hospital.

In a day hosptial all staff members must be able to make rapid decisions, even when they cannot refer to their seniors. It is difficult to develop this capability in a teaching day hospital where the staff and student groups are constantly changing. It has, however, been facilitated by regular staff discussions with a visiting psychotherapist. In these staff groups, the study of role attributions and dynamics characteristic of families has diminished the interference caused by 'family' type dynamics in daily professional interaction. The paper describes the effect of such discussion in stimulating the adoption of a treatment approach which takes the family situation into account. This family approach is distinguished from family therapy, and its advantages are discussed.

Attitude of Health Personnel↗

Health policy development in Lithuania.

The process of formulating a national health policy in Lithuania, a country in transition, has undergone several stages. Despite the existence of a national critical mass of professionals who understand the major principles of health policy development and who have a solid database to scientifically back the suggested decisions, and despite general acceptance by the public of the broader dimensions of health, the actual process of developing health policy is still facing considerable difficulty. Many factors obstruct this process, such as the inflexibility and resistance of the medical profession, traditions from the previous health service model and an extremely difficult economic situation. Nevertheless, one of the most important factors is the frequent change of government and, subsequently, of ministers of health, which makes continuity difficult. Fortunately, however, in contrast to the political level, the health professionals involved in health policy development and implementation assure at least one level of this necessary continuity. As a result of continuous efforts by the Health Reform Management Group and research and education institutions, and with the constant support of WHO, a policy and strategy for health for all continues to be developed, and the groundwork is being laid for improved dialogue and participation.

Cooperative Behavior↗

A 'second life' agenda. Psychiatric research issues raised by protease inhibitor treatments for people with the human immunodeficiency virus or the acquired immunodeficiency syndrome.

Seldom in the history of medicine has an entire generation of patients with an incurable, progressive, and ultimately fatal disease suddenly been offered the prospect of extended survival and even, perhaps, a "second life." The relatively simultaneous appearance of 2 major treatment developments has created profound changes in therapeutic options and outlook. The first development is an assay of serum levels of human immunodeficiency virus viral copies, providing a critical tool for clinical decision making. The second is the marketing between December 1995 and April 1997 of 4 human immunodeficiency virus protease inhibitors that, combined with previously available antiviral medications, achieve a new level of efficacy. With the advent of these changes come multiple psychiatric research and policy issues. These include the development of strategies to establish and maintain medication adherence. This is a critical task, given the complexity of combination therapy regimens and the rapid onset of viral resistance to protease inhibitors within days to weeks of missed or suboptimal dosing. The psychological issues to be studied include the process of restructuring lives and expectations in the event of clinical benefit or managing the distress associated with clinical failure. Other research questions include the effects of restored health on the appraisal of human immunodeficiency virus risk behaviors, assessment of effect of neurocognitive functioning, and unanswered questions about psychotropic or protease inhibitor drug interactions due to their shared metabolic pathways. Behavioral scientists can inform provision of care to patients who may be considered difficult to treat, such as those with severe and persistent mental illness or active substance abuse or the homeless. This includes the provision of empirical data regarding individual and situational characteristics that are likely to promote or impede adherence, as well as innovative provision systems. Psychiatry can make notable contributions during this turning point in human immunodeficiency virus therapeutics and research.

Acquired Immunodeficiency Syndrome↗

An ethical case for patient self-determination.

The self-determination of patients can be impeded or enhanced to a significant extent by the professionals who care for them. The autonomy of cancer patients especially is affected by their care givers. These patients often face difficult choices in the management of their illness: decisions about pain control, treatment choice, research participation, family involvement, withdrawal of treatment, and the degree to which they wish to be informed in making each of these decisions. The extent to which consent is free and informed and the autonomy of the patient not impeded, but positively enhanced, is determined by the professional. Is it fair to assign the professional so much responsibility for patient autonomy? Are patients not free to make decisions as they wish? In a technological society, serious illness is managed by professionals who incur a major share of responsibility for the degree of freedom that patients exercise. When patients are not encouraged and assisted to exercise their freedom, they cannot be autonomous. When an experience is brought under professional management, self-determination is possible only to the extent that it is both protected and promoted, or actively advocated. In the care of cancer patients, the central responsibility for advocacy belongs to the professional best situated within the framework of health care to sustain a partnership with the patient, and that professional is the nurse.

Attitude of Health Personnel↗

Do physicians not offer useful services because of coverage restrictions?

Ethically, physicians should discuss all medically appropriate services with patients, but coverage restrictions can make these discussions difficult. In a national survey of physicians, we asked how often physicians elected not to offer their patients useful services because of health plan coverage rules. During the course of a year, 31 percent reported having sometimes not offered their patients useful services because of perceived coverage restrictions. Among these, 35 percent reported doing so more often in the most recent year than they did five years ago. It can be frustrating for doctors to discuss uncovered services with their patients, but open communication is necessary for shared decision making and to improve coverage decisions.

American Medical Association↗

Outcomes research is the fifth discipline of the fifth generation of managed care: utility of a single troponin-T.

OBJECTIVE: The fifth generation of managed care is disease management. Diseases have measurable risk in providing laboratory and medical services. The link between managing services and managing risk can be aided by leveraging the laboratory. We wish to remodel laboratory services to fit the needs of the use, thereby using the laboratory for competitive advantage by redesigning a desired output using a formal structured process. Outcomes research is the systems framework for the remodeling process through the link of laboratory output to clinical and financial outcomes. A process redesign model connects the use of laboratory tests to improved medical services by leveraging resources to achieve measurable improvement over current results. This view of outcomes research seeks both competitive advantage and measurable improvements in quality. METHODOLOGY: This approach is illustrated by the patient presenting with chest pain (CP). A majority of the patients rule out for acute myocardial infarction (AMI), including patients with indigestion, shortness of breath, and other clinical findings. This is the basis for an emergency department (ED) CP observation unit to reduce coronary care unit admission rates. When the Goldman algorithm for discharging low-risk patients with CP from the ED using only clinical features and electrocardiographic findings proved difficult to implement, we turned to measuring the diagnostic efficiency of a new cardiac marker to replace the evolutionary changes in creatine kinase (CK) isoenzyme MB. The physicians making the decision were blinded to the results of the study. We fitted the expected characteristics of the test to the expected results for our program. The test was done on the presenting specimen of 293 evaluable patients with a median of 6.5 hours from the time of onset of CP to the time the specimen was drawn. The result was compared with the evolutionary pattern of CK-MB. RESULTS: The sensitivity of the test at presentation to the ED was 85% compared with < 50% for the presenting CK-MB, the false negative results taken earlier than 3 hours or 10 days after the onset of symptoms. Troponin-T effectively identifies non Q-wave AMI much earlier than the CK-MB. This study led to a prospective randomized clinical trial to demonstrate an improved medical and financial benefit from an early rule in or rule out of severe coronary artery ischemia. CONCLUSION: The study supports our hypothesis that the laboratory can systematically redesign its technology strategy and participate in the construction of a clinical pathway for the discharge from ED or admitting decisions with a test 98% sensitive for identifying patients with serious coronary ischemia by 3.5 hours after the onset of symptoms.

Biomarkers↗

Mobilization for cervical cancer screening: lessons from a poor-urban Yoruba community in Nigeria.

Cervical cancer is a major public health problem worldwide and it remains one of the commonest malignancies in Nigeria. Screening remains the most effective tool for the detection of pre-invasive stages of cervical cancer, giving the opportunity for prompt and effective treatment before the emergence of invasive disease. In Nigeria, as in most developing countries, the concept of screening for cancer and its pre-emptive treatment is underdeveloped. The fact that the facilities and logistics for cervical cancer screening are generally located in the hospital setting, a place where one goes when ill, according to local beliefs, makes acceptance more difficult. That Nigeria urgently needs to set up or develop cervical screening programmes that will reach women outside the hospital setting in a culturally acceptable milieu is not in doubt. A community cervical screening survey for the prevalence of cervical intraepithelial neoplasia and HPV infection was initiated in Idikan, a poor-urban inner core area of Ibadan. The challenges and experiences encountered in the execution of the project which could serve as useful knowledge to those undertaking similar exercises, requiring mass mobilization for cancer screening of an uninformed group, are highlighted. Our experience in the course of this study is important as it brought out the probable influences of community dynamics and social organization in illness decisions and prescriptions for health operative in this particular population group. Cervical cancer screening programmes should therefore make provisions to accommodate the occasional outcomes as we had encountered. In addition, screening programmes in developing societies would require sensitive designs that should address the cultural attitudes, personal conflicts, expectations of treatment and overall context of preventive care.

Adolescent↗