In relation to individual X and individual Y with the same genomic makeup but different in utero environmental influences, metabolic changes that may be initiated in utero in response to inadequate nutritional supplies (Figure 1-1) can lead to insulin resistance and eventually the development of type 2 diabetes. These adaptive changes can even result in a reduced number of nephrons in the kidneys as a stressed fetus conserves limited nutritional resources for more important in utero organ systems. This can then lead to a greater risk for hypertension later in life. This series of initially protective but eventually harmful developmental changes was first described in humans by David Barker, a British epidemiologist, who carefully assessed birth records of individuals and linked low birth weight to the development of hypertension, diabetes, atherosclerosis, and stroke later in life. The association among poor fetal growth during intrauterine life, insulin resistance, and cardiovascular disease is known as the Barker hypothesis. The process whereby a stimulus or insult, at a sensitive or critical period of fetal development, induces permanent alterations in the structure and functions of the baby’s vital organs, with lasting or lifelong consequences for health and disease, is now commonly referred to as developmental programming.

FIGURE 1-1 The potential effects of life-course nutritional determinants (intrauterine and lifelong) on subsequent adult health.

(From Bateson P, Barker D, Clutton-Brock T, et al: Developmental plasticity and human health. Nature 430:419-421, 2004. Adapted by permission from Macmillan Publishers Ltd.)

Third, another important concept in the life-course perspective is allostasis, which describes the body’s ability to maintain stability during physiologic change. A good example of allostasis is found in the body’s stress response. When the body is under stress (biological or psychological), it activates a stress response. The sympathetic system kicks in, and adrenalin flows to make the heart pump faster and harder (with the end result of delivering more blood and oxygen to vital organs, including the brain). The hypothalamic-pituitary-adrenal (HPA) axis is also activated to produce more cortisol, which has many actions to prepare the body for fight or flight.

But as soon as the fight or flight is over, the stress response is turned off. The body’s sympathetic response is counteracted by a parasympathetic response, which fires a signal through the vagal nerve to slow down the heart, and the HPA axis is shut off by cortisol through negative feedback mechanisms. Negative feedback mechanisms are common to many biological systems and work very much like a thermostat. When the room temperature falls below a preset point, the thermostat turns on the heat. Once the preset temperature is reached, the heat turns off the thermostat. Stress turns on the HPA axis to produce cortisol. Cortisol, in turn, turns off the HPA axis to keep the stress response in check. The body has these exquisite built-in mechanisms for checks and balance to help maintain allostasis, or stability through change.

This stress response works well for acute stress; it tends to break down under chronic stress. It works well for stress one can fight off or run from, but it doesn’t work as well for stress from which there is no escape. In the face of chronic and repeated stress, the body’s stress response is always turned on, and over time will wear out. The body goes from being “stressed” to being “stressed out”—from a state of allostasis to allostatic overload. This describes the cumulative wear and tear on the body’s adaptive systems from chronic stress.

The life-course perspective synthesizes both the developmental programming mechanisms of early life events and allostatic overload mechanisms of chronic life stress into a longitudinal model of health development. It is a way of looking at life not as disconnected stages but as an integrated continuum. Thus, to promote healthy pregnancy, preconception health must first be promoted. To promote preconception health, adolescent health must be promoted, and so forth. Rather than episodic care that many women receive, as a specialty we must strive toward disease prevention and health promotion over the continuum of a woman’s life course.

IMPACT ON PUBLIC HEALTH

The public health implications of the Barker hypothesis and other life-course events leading to health or the development of disease are significant. This is the beginning of an exciting era in medicine during which young physicians can begin to take charge of these events and change our health-care delivery system in a very positive way. A large part of this will occur by encouraging patients to take responsibility for improving their own health, particularly by practicing healthy behaviors early in life. They should also be encouraged to improve and maintain a healthy “green” environment. Currently, there are only a few environmental and behavioral factors that have been clearly identified as part of the Barker hypothesis. Many others are yet to be discovered.

Adaptive developmental plasticity will take place secondary to changes in genes as a result of environmental and behavioral practices. Even the controversial concept of climate change may play a role in this phenomenon. New knowledge over the next 10 to 20 years should help us to accelerate the development of focused interventions at all levels to mitigate and prevent disease and improve the health of women and their children.

Biological processes are powerful and frequently unpredictable. Physicians must decide what role they will play in a safe, ethical, and effective practice. Learning is fun and exciting, and patients who wish to be informed about their health and health care will be grateful for the wellness and good health provided to them.

The four basic principles and guidelines mentioned earlier—patient safety, ethical practice, quality improvement, and the need for a focus on prevention—are covered next.

Patient Safety

Safety in health care is not a new concept. Facilities have had safety programs in place since the early 1900s, but these programs have traditionally focused on emergency preparedness, environmental safety, security, and infection control. The term patient safety, meaning avoidance of medical error, was first coined by the American Society of Anesthesiologists in 1984 when they inaugurated the Anesthesia Patient Safety Foundation to give assurance that the effects of anesthesia would not harm patients.

Medical errors now rank as the fifth leading cause of death in the United States. The Institute of Medicine (IOM) published an alarming report in 1999 called To Err Is Human: Building a Safer Health System. This report estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors. Error is defined as failure of a planned action to be completed as intended (e.g., failing to operate when obvious signs of appendicitis are present) or the use of a wrong plan to achieve an aim (e.g., wrong diagnosis, wrong medication administered). Medication errors alone, occurring either in or out of the hospital, are estimated to account for more than 7000 deaths annually. According to the National Council on Patient Information and Education, “more than 2/3 of all physician visits end with a prescription.” An estimated 39% to 49% of all medication errors occur at the stage of drug ordering. Patient noncompliance also contributes to medical errors.

The United States Pharmacopoeia (USP) MEDMARK error tracking service estimates that as many as 100,000 medication errors occur annually. Because reporting is voluntary and does not include all medical facilities in the United States, the scope of the problem is likely to be much larger. A preventable adverse drug event (ADE) is one type of medication error. Administering the incorrect drug, an incorrect dose, wrong frequency, or incorrect route may cause an ADE.

A drug that cures one patient’s condition may be the one that causes another patient’s injury or death owing to an adverse drug reaction (ADR). The latter may account for 1 out of 5 injuries or deaths for hospitalized patients. ADRs commonly occur from an overdose, a side effect, or an interaction among several concomitantly administered drugs. To minimize ADRs, health-care providers should avoid the following actions:

1. Prescribing unnecessary medications

2. Treating mild side effects of one drug with a second, more toxic drug

3. Misinterpreting a drug’s side effect for a new medical problem and prescribing another medication

4. Prescribing a medication when there is any uncertainty about dosing

In the absence of automated systems, health-care professionals should strive to write legibly and use only approved abbreviations and dose expressions. Most health-care facilities publish and circulate an acceptable list of appropriate abbreviations as a means of reducing medication errors.

MEDICAL ERROR REPORTING

According to the U.S. Agency for Healthcare Research and Quality (AHRQ), “Reporting is an important component of systems to improve patient safety.” Incident reporting is an important and inexpensive method to detect medical error and prevent future adverse events. Unfortunately, this method may fail to affect clinical outcomes because most hospital reporting systems do not capture most errors. Reporting should be considered a quality improvement process (focused on system failures) rather than a performance evaluation method (blaming individual providers).

As a founding member of the National Patient Safety Foundation and the National Patient Safety Partnership, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), now more commonly known as The Joint Commission (TJC), has formed a coalition with the USP, the American Medical Association (AMA), and the American Hospital Association (AHA) to create patient safety reporting principles. Recognizing that fear of liability discourages error reporting, TJC has advised the U.S. Congress that federal statutory protection must be afforded to those who report medical error. An anonymous nonpunitive environment will encourage reporting. Many states have implemented mandatory reporting systems for selected medical errors to improve patient safety and reduce errors. Others consider incident reporting and analysis as peer review activities immune from liability. The Institute of Medicine (IOM) recommends that health-care providers be required to report errors that result in serious harm. Information collected should be made available to the public. AHRQ publishes case summaries of reported medical errors and near misses on their website.

DISCLOSURE OF MEDICAL ERROR

The National Patient Safety Foundation (NPSF) was one of the first organizations to address the issue of disclosure. Their position, finalized in November 2000, states that when a health-care injury occurs, the patient and family or representative is entitled to a prompt explanation of how the injury occurred and its short-term and long-term effects. When an error contributed to the injury, the patient and family or representative should receive a truthful and compassionate explanation about the error and the remedies available to the patient. They should be informed that the factors involved in the injury will be investigated so that steps can be taken to reduce the likelihood of similar injury to other patients.

TJC now requires hospitals to disclose any serious harm caused by medical errors to the harmed parties. Disclosing error can be very difficult for physicians because they may struggle with intense feelings of incompetence, betrayal of the patient, and fear of litigation. Studies suggest that physicians with good relationship skills are less likely to be sued. Furthermore, suits settle rapidly and for less money when errors are disclosed early. Simple rules for disclosing errors include admitting the mistake, acknowledging the listener’s anger, speaking slowly, and stopping frequently to allow the listener to talk. Tell the person that an error has occurred and apologize. Usually, the attending physician is the one who should disclose. Medical students should not disclose because they may not be prepared to offer advice on necessary follow-up.

Ethical Practice of Obstetrics and Gynecology

Obstetrics and gynecology encompasses many high-profile areas of ethical concern such as in vitro fertilization (IVF) and other assisted reproductive technologies (ARTs), abortion, the use of aborted tissue for research or treatment, surrogacy, contraception for minors, and sterilization of persons with a mental illness. Nevertheless, most ethical problems in the practice of medicine arise in cases in which the medical condition or desired procedure itself presents no moral problem. In the past, the main areas of ethical concern have related to the competence and beneficence of the physician. Current areas of ethical concern should include the goals, values, and individual and appropriate cultural preferences of the patient as well as those of the community at large. Consideration of such issues enriches the study of obstetrics and gynecology by emphasizing that scientific knowledge and technical skills are most meaningful in a social and moral context.

ETHICAL PRINCIPLES

During the day-to-day consideration of ethical dilemmas in health care, a number of principles or ideals and the concepts derived from them are commonly accepted and taken into account. Four such principles or ideals are nonmaleficence, beneficence, autonomy, and justice; these are generally accepted as the major ethical concepts that apply to health care.

P	lan	The course of action being considered
R	eason	The indication or rationale
E	xpectation	The chances of benefit and failure
P	references	Cultural and patient-centered priorities (utilities) affecting choice
A	lternatives	Other reasonable options/plans
R	isks	The potential harm from plans
E	xpenses	All direct and indirect costs
D	ecision	Fully informed collaborative choice

Modified from Reiter RC, Lench JB, Gambone JC: Consumer advocacy, elective surgery, and the “Golden Era of Medicine.” Obstet Gynecol 74:815, 1989.

The exercise of autonomy may cause considerable stress and conflict for those providing health care, as in the case of a woman with a ruptured ectopic pregnancy who refuses a lifesaving blood transfusion for religious reasons and dies despite the best efforts of the medical team. More complex questions may be raised by court-ordered cesarean births for the benefit of the fetus.

Justice

Justice relates to the way in which the benefits and burdens of society are distributed. The general principle that equals should be treated equally was espoused by Aristotle and is widely accepted today, but it does require that one be able to define the relevant differences between individuals and groups. Some believe all rational persons to have equal rights; others emphasize need, effort, contribution, and merit; still others seek criteria that maximize both individual and social utility. In most Western societies, race, sex, and religion are not considered morally legitimate criteria for the distribution of benefits, although they too may be taken into account to right what are perceived to be historical wrongs, in programs of affirmative action. When resources are scarce, issues of justice become even more acute because there are often competing claims from parties who appear equal by all relevant criteria, and the selection criteria themselves become a moral issue. Most modern societies find the rational rationing of health-care resources to be appropriate and acceptable (Figure 1-2).

FIGURE 1-2 Representation of arbitrary rationing commonly based on access or ability to pay vs. planned clinical resource management based on measured value. Explicit rationing is objectionable to many despite the fact that implicit rationing still occurs.

OTHER DUTIES OF ETHICAL PRACTICE

Confidentiality is a cornerstone of the relationship between physician and patient. This duty arises from considerations of autonomy but also helps promote beneficence, as is the case with honesty. In obstetrics and gynecology, conflicts can arise, as in the case of a woman with a sexually transmitted disease who refuses to have a sexual partner informed, or a school-aged child seeking contraceptive advice or an abortion.

There are many other situations in which conflicting responsibilities make confidentiality a difficult issue. The U.S. Health Insurance Portability and Accountability Act (HIPAA) mandates strict rules that physician practices and health-care facilities must adhere to regarding the confidentiality and security of patient health-care records. Some are concerned that these regulations could restrict the flow of information about patient care and may hinder efforts to improve overall performance.

Caring for a pregnant woman creates a unique maternal-fetal relationship because the management of the mother inevitably affects her baby. Until recently, the only way by which an obstetrician could produce a healthy baby was by maintaining optimal maternal health, but as the fetus becomes more accessible to diagnostic and therapeutic interventions, new problems emerge. Procedures performed on behalf of the fetus may violate the personal integrity and autonomy of the mother. The obstetrician with a dual responsibility to mother and fetus faces a potential conflict of interest. Most conflicts will be resolved as a result of the willingness of most women to undergo considerable self-sacrifice to benefit their fetus. When a woman refuses consent for a procedure that presents her with significant risk, her autonomy will generally be respected. However, there may be cases in which an intervention that is likely to be efficacious carries little risk to the mother and can reasonably be expected to prevent substantial harm to the fetus. These have occasionally ended in a court-ordered intervention.

Health care is a multidisciplinary activity, and respectful and collegial relationships with other health professionals are very important. Although the physician has traditionally been the only decision-maker, this situation has often caused concern among other health-care professionals. There is increasing recognition that other clinicians involved in health care have a right to participate in any decision-making. Physicians have not been as aware of the sensitivities of the nursing profession and other allied health professionals as they should have been. For example, the decision, no matter how it is made, to either operate or not on a newborn with severe spina bifida inevitably leaves nurses with responsibilities to the infant, the parents, and the doctor that may be in direct conflict with their personal values. They may rightly request to be party to the decision-making process, and although the exact models whereby such a goal may be achieved are debatable, physicians must be aware of the legitimate moral concerns of nurses and others involved.

And finally, health-care delivery takes place in a complex environment, and relationships with other interested parties are becoming increasingly important. Hospitals, health insurance companies, and governments all claim an interest in what services are made available or paid for, and this may prevent individual patients from receiving what their physician may consider optimal care. This poses moral problems not only for physicians on a case-by-case basis but also for insurance companies and society as a whole.

The interface of medicine and the law raises major ethical issues because legality and morality are not always synonymous. Professional liability insurance premiums for obstetricians are testimony to the relevance of legal issues to obstetric practice. Professional liability is affecting every major decision that is made by the practicing obstetrician and gynecologist, and under these conditions, the “tunnel vision” that ensues may obscure the ability to see clear answers to ethical questions.

Health-Care Quality Improvement

PRACTICING MORE EFFECTIVELY

The mandate from payers (government and employers) and the public to measure and improve the effectiveness of health-care services is clear. Unfortunately, change based on adoption of national standards derived from evidence-based practice and randomized controlled trials (RCTs) alone may be too expensive and slow to meet this mandate. Furthermore, the results from RCTs may not always establish how diagnostic and therapeutic procedures actually work in clinical practice. For these reasons, health-care organizations and physician groups must develop the tools to identify and adopt best practices and improve clinical outcomes locally.

Paralleling the evolving science of outcomes assessment is the evolving science of outcomes improvement. Health-care organizations have adapted successful models of continuous quality improvement from industry as well as newer research or “evidence-based” models of care. Adoption of “best practice” models of care must be based on continuous reassessment of evolving practice, research, and innovation. Methods such as the FOCUS-PDCA cycle (Figure 1-3), originally developed at Bell Laboratories to test small incremental changes, have been applied to health-care processes and used successfully for continuous quality improvement programs. Use of such a standardized method has been shown to improve the effectiveness of clinical improvement efforts and accelerate the pace of needed change. Several other key clinical improvement tools are highlighted below.

FIGURE 1-3 FOCUS-PDCA. A continuous improvement model to guide the process of making improvements now widely used in health care.

(From Langley DJ, et al: The Improvement Guide. San Francisco, Jossey-Bass, 1996.)

CLINICAL GUIDELINES

Unintended variation in health-care processes generally connotes, and frequently results in, lower quality of care. Clinical guidelines, also referred to as protocols, practice parameters, algorithms, and clinical pathways, are tools that have been developed to reduce wasteful variation in the performance of medical and surgical procedures and to improve outcomes of care.

A guideline is a summary of optimal care processes for a medical condition stated in general terms so as to allow sufficient variation for patient differences and preferences. Previously, guidelines were derived largely by consensus and the opinion of experts. More recently, these authority-based guidelines have been replaced by so-called evidence-based guidelines, which are based on objective evaluation of outcomes and the available medical literature. Adoption of evidence-based guidelines, such as those produced by the AHRQ, the U.S. Preventive Services Task Force, and the international Cochrane Collaborative, has been shown to improve health-care outcomes and reduce costs. However, their acceptance has not been widespread in the United States, in part because of the financial consequences of their adoption.

Clinical pathways (also known as critical paths or care maps) are broad, detailed multidisciplinary guidelines that organize, sequence, and time the best or ideal management strategy, usually for a specific condition or procedure. For example, a pathway for patients undergoing hysterectomy details diagnostic and therapeutic milestones that are expected on each day of the patient’s hospital stay. About 80% to 90% of patients are expected to stay on the pathway during treatment.

Disease management protocols are comprehensive approaches to patient care for an entire episode of illness (inpatient and outpatient). A disease management model provides guidelines for the continuous tracking and modification of the care plan, facilitation of care across clinical services, confirmation of service delivery, and evaluation of variances in practice and outcomes.

Focus on Prevention

The prevention and mitigation of existing disease has become an extremely important and sometimes overlooked area of effective practice. The famous American humorist, Will Rogers, said many years ago that people should only pay their doctors when they are well and not sick. This suggests a frustration that he was reflecting publicly that medical practice has neglected the promotion of wellness. As health-care treatment becomes more expensive and complex, there is a greater incentive for government, private industry, and individuals to invest in preventive services. The wise students of medical practice, including obstetrics and gynecology, will benefit from more education and training in prevention—and so will their patients. Box 1-1 contains a life-course perspective of early, effective prevention opportunities.

One recent example of a preventive intervention that is available in gynecologic practice is the vaccination against human papillomavirus (HPV) infection to prevent cervical cancer (see Chapters 22 and 38). This new technology illustrates both the promise of prevention and the controversy that can surround the use of some preventive measures.

IMMUNIZATIONS AND PREVENTIVE HEALTH SCREENING

Because public health recommendations for immunizations may change, it is best to check a reliable source periodically (e.g., www.cdc.gov) for the latest information before counseling patients. General recommendations include the following for women aged 19 to 49 years: measles, mumps, and rubella (MMR), hepatitis B, and varicella for women who are nonimmune. Additionally, vaccination against HPV is currently recommended for girls and women aged 11 to 26 years, and a single dose of tetanus-diphtheria-pertussis (Tdap) for adults 19 to 64 years of age is now recommended to replace the next booster dose of tetanus and diphtheria toxoids (Td) vaccine. Influenza vaccine is recommended annually for all women older than age 50 years and for women aged 19 to 49 years who are health-care workers, who have chronic illnesses such as heart disease or diabetes mellitus, or who are pregnant or planning to become pregnant during the flu season. Pneumococcal vaccine is recommended for all women aged 65 years and older, for those with chronic illness or alcoholism, and for those who are immunosuppressed. Meningococcal and hepatitis A vaccines may be indicated in some women with risk factors. Remember that MMR, varicella, and HPV vaccines are contraindicated during pregnancy.

Table 1-2 contains recommended preventive health screening procedures for women.

TABLE 1-2 RECOMMENDED PREVENTIVE HEALTH SCREENING FOR WOMEN

Intervention/Procedure	Risk
Pap smear annually from age 21 yr or sexual activity; after three consecutive normal smears, every 2 to 3 yr in low-risk women from age 30 until 70 yr	Cervical dysplasia/cancer
Mammography every other year from age 40 yr and then annually from age 50 to 70 yr	Breast cancer
Smoking cessation counseling, warning second-hand smoke exposure	Lung cancer, heart disease, other health risks associated with smoking
Height and weight measurement	Overweight and obesity
Regular blood pressure screening (every 2 yr)	Hypertension and stroke
Cholesterol/lipid profile every 5 yr until age 65 yr	Heart disease
Total skin inspection and selective biopsies	Skin cancer (sun exposure)
Diet and exercise counseling	Osteoporosis, fracture, and deformity
Blood sugar study with family history, obesity, or history of gestational diabetes	Diabetes mellitus; other comorbidities associated with obesity
Sigmoidoscopy or colonoscopy every 3 to 5 yr after age 50 yr	Colorectal cancer
Cervical sampling for Chlamydia, Neisseria gonorrhoeae, syphilis, and HIV based on history	Sexually transmitted infections
PPD of tuberculin for high-risk women	Tuberculosis