The Patient Care and Medical Investigation Essay

Section 1: Public Health and Public Health Practices/Investigations
Public health is the discipline and skill for preventing diseases and injuries, extending the lifespan and endorsing wellbeing through structured public work, the control of communicable diseases, the union of medical and nursing facilities for the prompt identification and disease prevention, teaching individual health and to make sure a standard of living suitable for the conservation of health (Breslow et al, 2002).. Public health focuses the health of the people completely than the treatment of individuals (Beaglehole et al, 2004). The Patient Care and Medical Investigation Essay

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The public health principles are meant for the public and other institutions that have a public health mission.
Preventing diseases needs various methods at each level. Some consist of education, awareness campaigns, legislation and modifying the surroundings. Disease/injuries need to be addressed at more than one level, and time and again all three. It is essential to recognize which prevention strategies are shown effective in order to have the utmost effect on your chosen program (Christoffel & Gallagher, 2005). Public health should predominantly address the vital causes of disease and necessities for health which in turn aims to avoid adverse health consequences. For instance, the handling of treatable infections is essential to the deterrence of transmission of infection. Public health must reach community health which compliments the rights of those in the public. This Principle recognizes the mutual need in public health to ponder the concerns of the individual and the public. An ethical principle does not exist to deliver an explanation or answer to this constant pressure in public health. Public health guidelines, programs, and priorities ought to be established and assessed over to guarantee an opening for feedback from the public. The capability for the community to offer this contribution and intellect is dire in the progress and preservation of communal trust in the society. Public health must sponsor and work for the authorizations of subjugated fellows, pointing to make sure that the wealth The Patient Care and Medical Investigation Essay

This chapter provides an overview of diagnosis in health care, including the committee’s conceptual model of the diagnostic process and a review of clinical reasoning. Diagnosis has important implications for patient care, research, and policy. Diagnosis has been described as both a process and a classification scheme, or a “pre-existing set of categories agreed upon by the medical profession to designate a specific condition” (Jutel, 2009).1 When a diagnosis is accurate and made in a timely manner, a patient has the best opportunity for a positive health outcome because clinical decision making will be tailored to a correct understanding of the patient’s health problem (Holmboe and Durning, 2014). In addition, public policy decisions are often influenced by diagnostic information, such as setting payment policies, resource allocation decisions, and research priorities (Jutel, 2009; Rosenberg, 2002; WHO, 2012).The Patient Care and Medical Investigation Essay

Health care is one of the most corrupt sectors in Russia. In 2015 twenty percent of patients paid a bribe for the health care services once or twice, and thirteen percent more than
twice (Russian Public Opinion Research Center, 2015). Using data on adults from over 5,000
households in Russia, this three-essay study analyzes out-of-pocket formal (official) and informal (unofficial, bribes) payments for the health care.
In the first essay, I study whether there is a difference in the amount of unofficial payments across five types of health care services (ambulance, inpatient, outpatient, dental, and
medical checkups) and two types of health care facilities (state and private). Finally, I examine
whether the purchase of private health insurance reduces unofficial health care payments. Using
fixed and random effects models, I find that adults incur the highest informal expenditures on
dental, outpatient and inpatient care. The bribes are higher in state compared to private facilities.
There are a few reasons for that. First, there is generally lower quality of services and longer
waiting lines in state hospitals. Therefore, patients use bribes as a mechanism to guarantee
themselves higher quality of care. Second, the salaries of doctors in state facilities are lower
than in private hospitals. I also find evidence that the purchase of private health insurance reduces patients’ informal payments. People buy private insurance to guarantee themselves access to better services. In the second essay, I examine whether the official payment increases
or decreases the likelihood of people paying unofficially. If official and unofficial payments are
negatively related, then the payments are substitutes. If an increase in the formal payment increases the probability of informal spending, then they are complements. Patients have different
motivations for paying a health care bribe. Some may seek to access services in short supply or
to avoid official fees, thereby substituting informal for formal payments. Others may view informal payments as a tip or gratuity, which would make unofficial payments a complement to
official payments. I find that in the Russian health care market formal and informal payments
are substitutes. However, there is significant heterogeneity across different types of services. In
particular, bribes and official payments act as substitutes in the case of dental care and medical
check-ups, while they are complements in inpatient care.
In the third essay, I study whether Russians residents (native born and foreign born) are
less likely to pay informally for their health care than foreign born non-residents that do not
have state provided health insurance. I find that the residents have a lower probability of paying
unofficially than non-residents and that if they pay a bribe, then, on average, its amount is lower
than that of a non-resident. In addition, the difference in the probability and the amount of
informal payments between residents and non-residents is higher in private than state hospitals,
regardless of whether patients have private insurance or not. For non-residents, private insurance plays the biggest role in the reduction of their informal spending in private hospitals.The Patient Care and Medical Investigation Essay

The question focuses on the financial constraints that have been imposed upon the NHS and the potential effects on patient care and rationing of treatment. You may want to begin your answer with a brief description of the inception of the NHS with recognition that at that time it was a unique healthcare service that aimed to offer healthcare for all that was free at the point of delivery. However, over the last 65 years or so, the socio-political and demographic landscape has changed considerably, imposing numerous strains upon the system.

Two issues that you might wish to consider which have been instrumental in this change are demographic change as well as advances in medical technology. There is an increasing proportion of older persons and the total population has increased considerably over the last half century. People are also living longer. Advances in medical technology mean that options for investigation and treatment are getting more plentiful, sophisticated and costly. The NHS has a finite budget and how can it be expected to cope with this increasing demand?The Patient Care and Medical Investigation Essay

Section 1 of the National Health Service Act 2006 obliges the Secretary of State to promote a comprehensive Health Service designed to secure improvement in the physical and mental health of the people of England and extends to the prevention, diagnosis and treatment of illness. The duty is discharged through a number of NHS bodies. Major structural changes have been introduced recently by the Health and Social Care Act 2012. These changes include the commissioning and procurement of NHS services. Arguably the biggest change has been the devolution of commissioning to general practitioner consortia called Clinical Commissioning Groups (CCGs). CCGs are overseen by NHS England. You may wish to comment upon this new structure and outline briefly your views on how this might evolve in respect of potential benefits and challenges.The Patient Care and Medical Investigation Essay

With regard to resource allocation, it must be remembered that scarcity of resources is not a new problem. One of the earliest cases that dealt with this issue was R v. Cambridge DHA ex p B [1995], in which Sir Thomas Bingham MR recognised that difficult and agonising decisions have to be made when ascertaining how limited budgets are best allocated for maximum benefit for the greatest number. Resource allocation decisions tend to be tackled in two ways. The first is to evaluate the efficacy of treatment using quality adjusted life years (QALYs). You may wish to discuss the rationale behind QALYs, remembering that these include elements that are subjective to the decision-maker.

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The second aspect of contemporary rationing decisions concerns specialist high cost therapies. Healthcare commissioners have to decide whether to fund such therapy. There is considerable recent case law in this area. Funding bodies need to determine ?exceptionality? in each individual case (Rogers) but if commissioners operate policies of never funding a treatment, then this might be regarded as an illegitimate blanket policy (Rogers). The courts have emphasised the need for proportionality and that the funding body should consider being less restrictive in evaluating cost effectiveness at end-of-life (Ross). It should also be remembered that ?exceptional? does not necessarily mean that the patient in the case in question is the only person with this condition. In other words a similar patient in a similar situation would not necessarily negate the concept of exceptionality (Ross). Should funding bodies expressly state that cost is a relevant factor? To some extent this issue was addressed in Rogers and Otley, and you may wish to include judicial commentary in your answer.The Patient Care and Medical Investigation Essay

The chapter describes important considerations in the diagnostic process, such as the roles of diagnostic uncertainty and time. It also highlights the mounting complexity of health care, due to the ever-increasing options for diagnostic testing2 and treatment, the rapidly rising levels of biomedical and clinical evidence to inform clinical practice, and the frequent comorbidities among patients due to the aging of the popula-

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1 In this report, the committee employs the terminology “the diagnostic process” to convey diagnosis as a process.

2 The committee uses the term “diagnostic testing” to be inclusive of all types of testing, including medical imaging, anatomic pathology, and laboratory medicine, as well as other types of testing, such as mental health assessments, vision and hearing testing, and neurocognitive testing.The Patient Care and Medical Investigation Essay

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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tion (IOM, 2008, 2013b). The rising complexity of health care and the sheer volume of advances, coupled with clinician time constraints and cognitive limitations, have outstripped human capacity to apply this new knowledge. To help manage this complexity, the chapter concludes with a discussion of the role of clinical practice guidelines in informing decision making in the diagnostic process.

OVERVIEW OF THE DIAGNOSTIC PROCESS

To help frame and organize its work, the committee developed a conceptual model to illustrate the diagnostic process (see Figure 2-1). The committee concluded that the diagnostic process is a complex, patient-centered, collaborative activity that involves information gathering and clinical reasoning with the goal of determining a patient’s health problem. This process occurs over time, within the context of a larger health care work system that influences the diagnostic process (see Box 2-1). The committee’s depiction of the diagnostic process draws on an adaptation of a decision-making model that describes the cyclical process of information gathering, information integration and interpretation, and forming a working diagnosis (Parasuraman et al., 2000; Sarter, 2014).The Patient Care and Medical Investigation Essay

The diagnostic process proceeds as follows: First, a patient experiences a health problem. The patient is likely the first person to consider his or her symptoms and may choose at this point to engage with the health care system. Once a patient seeks health care, there is an iterative process of information gathering, information integration and interpretation, and determining a working diagnosis. Performing a clinical history and interview, conducting a physical exam, performing diagnostic testing, and referring or consulting with other clinicians are all ways of accumulating information that may be relevant to understanding a patient’s health problem. The information-gathering approaches can be employed at different times, and diagnostic information can be obtained in different orders. The continuous process of information gathering, integration, and interpretation involves hypothesis generation and updating prior probabilities as more information is learned. Communication among health care professionals, the patient, and the patient’s family members is critical in this cycle of information gathering, integration, and interpretation.The Patient Care and Medical Investigation Essay

The working diagnosis may be either a list of potential diagnoses (a differential diagnosis) or a single potential diagnosis. Typically, clinicians will consider more than one diagnostic hypothesis or possibility as an explanation of the patient’s symptoms and will refine this list as further information is obtained in the diagnostic process. The working diagnosis should be shared with the patient, including an explanation of the degree of uncertainty associated with a working diagnosis. Each time there is a

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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FIGURE 2-1 The committee’s conceptualization of the diagnostic process.

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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BOX 2-1
The Work System

The diagnostic process occurs within a work system that is composed of diagnostic team members, tasks, technologies and tools, organizational factors, the physical environment, and the external environment (see figure on opposite page) (Carayon et al., 2006, 2014; Smith and Sainfort, 1989):The Patient Care and Medical Investigation Essay

Diagnostic team members include patients and their families and all health care professionals involved in their care.
Tasks are goal-oriented actions that occur within the diagnostic process.
Technologies and tools include health information technology (health IT) used in the diagnostic process.
Organizational characteristics include culture, rules and procedures, and leadership and management considerations.
The physical environment includes elements such as layout, distractions, lighting, and noise.
The external environment includes factors such as the payment and care delivery system, the legal environment, and the reporting environment.
All components of the work system interact, and each component can affect the diagnostic process (e.g., a change in the physical environment may affect the usefulness and accessibility of health IT, and a change in the diagnostic team may affect the assignment of tasks). The work system provides the context in which the diagnostic process occurs (Carayon et al., 2006, 2014). There is a range of settings (i.e., work systems) in which the diagnostic process can occur—for example, outpatient primary or specialty care office settings, emergency departments, inpatient hospital settings, long-term care facilities, and retail clinics. Each of these includes the six components of a work system—diagnostic team members and tasks, technologies and tools, organizational factors, the physical environment, and the external environment—although the nature of the components may differ among and between settings. The six components of the work system and how they are related to diagnosis and diagnostic error are described in detail in Chapters 4–7.The Patient Care and Medical Investigation Essay

revision to the working diagnosis, this information should be communicated to the patient. As the diagnostic process proceeds, a fairly broad list of potential diagnoses may be narrowed into fewer potential options, a process referred to as diagnostic modification and refinement (Kassirer et al., 2010). As the list becomes narrowed to one or two possibilities, diagnostic refinement of the working diagnosis becomes diagnostic verification, in which the lead diagnosis is checked for its adequacy in explaining the signs and symptoms, its coherency with the patient’s context (physiology, risk factors), and whether a single diagnosis is appropriate. When considering invasive or risky diagnostic testing or treatment options, the

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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diagnostic verification step is particularly important so that a patient is not exposed to these risks without a reasonable chance that the testing or treatment options will be informative and will likely improve patient outcomes.The Patient Care and Medical Investigation Essay

Throughout the diagnostic process, there is an ongoing assessment of whether sufficient information has been collected. If the diagnostic team members are not satisfied that the necessary information has been collected to explain the patient’s health problem or that the information available is not consistent with a diagnosis, then the process of information gathering, information integration and interpretation, and develop-

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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ing a working diagnosis continues. When the diagnostic team members judge that they have arrived at an accurate and timely explanation of the patient’s health problem, they communicate that explanation to the patient as the diagnosis.The Patient Care and Medical Investigation Essay

It is important to note that clinicians do not need to obtain diagnostic certainty prior to initiating treatment; the goal of information gathering in the diagnostic process is to reduce diagnostic uncertainty enough to make optimal decisions for subsequent care (Kassirer, 1989; see section on diagnostic uncertainty). In addition, the provision of treatment can also inform and refine a working diagnosis, which is indicated by the feedback loop from treatment into the information-gathering step of the diagnostic process. This also illustrates the need for clinicians to diagnose health problems that may arise during treatment.

The committee identified four types of information-gathering activities in the diagnostic process: taking a clinical history and interview; performing a physical exam; obtaining diagnostic testing; and sending a patient for referrals or consultations. The diagnostic process is intended to be broadly applicable, including the provision of mental health care. These information-gathering processes are discussed in further detail below.The Patient Care and Medical Investigation Essay

Clinical History and Interview

Acquiring a clinical history and interviewing a patient provides important information for determining a diagnosis and also establishes a solid foundation for the relationship between a clinician and the patient. A common maxim in medicine attributed to William Osler is: “Just listen to your patient, he is telling you the diagnosis” (Gandhi, 2000, p. 1087). An appointment begins with an interview of the patient, when a clinician compiles a patient’s medical history or verifies that the details of the patient’s history already contained in the patient’s medical record are accurate. A patient’s clinical history includes documentation of the current concern, past medical history, family history, social history, and other relevant information, such as current medications (prescription and over-the-counter) and dietary supplements.The Patient Care and Medical Investigation Essay

The process of acquiring a clinical history and interviewing a patient requires effective communication, active listening skills, and tailoring communication to the patient based on the patient’s needs, values, and preferences. The National Institute on Aging, in guidance for conducting a clinical history and interview, suggests that clinicians should avoid interrupting, demonstrate empathy, and establish a rapport with patients (NIA, 2008). Clinicians need to know when to ask more detailed questions and how to create a safe environment for patients to share sensitive information about their health and symptoms. Obtaining a history can be chal-The Patient Care and Medical Investigation Essay

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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lenging in some cases: For example, in working with older adults with memory loss, with children, or with individuals whose health problems limit communication or reliable self-reporting. In these cases it may be necessary to include family members or caregivers in the history-taking process. The time pressures often involved in clinical appointments also contribute to challenges in the clinical history and interview. Limited time for clinical visits, partially attributed to payment policies (see Chapter 7), may lead to an incomplete picture of a patient’s relevant history and current signs and symptoms.The Patient Care and Medical Investigation Essay

There are growing concerns that traditional “bedside evaluation” skills (history, interview, and physical exam) have received less attention due the large growth in diagnostic testing in medicine. Verghese and colleagues noted that these methods were once the primary tools for diagnosis and clinical evaluation, but “the recent explosion of imaging and laboratory testing has inverted the diagnostic paradigm. [Clinicians] often bypass the bedside evaluation for immediate testing” (Verghese et al., 2011, p. 550). The interview has been called a clinician’s most versatile diagnostic and therapeutic tool, and the clinical history provides direction for subsequent information-gathering activities in the diagnostic process (Lichstein, 1990). An accurate history facilitates a more productive and efficient physical exam and the appropriate utilization of diagnostic testing (Lichstein, 1990). Indeed, Kassirer concluded: “Diagnosis remains fundamentally dependent on a personal interaction of a [clinician] with a patient, the sufficiency of communication between them, the accuracy of the patient’s history and physical examination, and the cognitive energy necessary to synthesize a vast array of information” (Kassirer, 2014, p. 12).The Patient Care and Medical Investigation Essay

Physical Exam

The physical exam is a hands-on observational examination of the patient. First, a clinician observes a patient’s demeanor, complexion, posture, level of distress, and other signs that may contribute to an understanding of the health problem (Davies and Rees, 2010). If the clinician has seen the patient before, these observations can be weighed against previous interactions with the patient. A physical exam may include an analysis of many parts of the body, not just those suspected to be involved in the patient’s current complaint. A careful physical exam can help a clinician refine the next steps in the diagnostic process, can prevent unnecessary diagnostic testing, and can aid in building trust with the patient (Verghese, 2011). There is no universally agreed upon physical examination checklist; myriad versions exist online and in textbooks.The Patient Care and Medical Investigation Essay

Due to the growing emphasis on diagnostic testing, there are concerns that physical exam skills have been underemphasized in current

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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health care professional education and training (Kassirer, 2014; Kugler and Verghese, 2010). For example, Kugler and Verghese have asserted that there is a high degree in variability in the way that trainees elicit physical signs and that residency programs have not done enough to evaluate and improve physical exam techniques. Physicians at Stanford have developed the “Stanford 25,” a list of physical diagnostic maneuvers that are very technique-dependent (Verghese and Horwitz, 2009). Educators observe students and residents performing these 25 maneuvers to ensure that trainees are able to elicit the physical signs reliably (Stanford Medicine 25 Team, 2015).The Patient Care and Medical Investigation Essay

Diagnostic Testing

Over the past 100 years, diagnostic testing has become a critical feature of standard medical practice (Berger, 1999; European Society

BOX 2-2
Laboratory Medicine, Anatomic Pathology, and Medical Imaging

Pathology is usually separated into two disciplines: laboratory medicine and anatomic pathology. Laboratory medicine, also referred to as clinical pathology, focuses on the testing of fluid specimens, such as blood or urine. Anatomic pathology addresses the microscopic examination of tissues, cells, or other solid specimens.The Patient Care and Medical Investigation Essay

Laboratory medicine is a medical subspecialty concerned with the examination of specific analytes in body fluids (e.g., cholesterol in serum, protein in urine, or glucose in cerebrospinal fluid), the specific identification of microorganisms (e.g., disease-causing bacteria in sputum, human immunodeficiency virus in blood, or parasites in stool), the analysis of bone marrow specimens (e.g., the identification of a specific of type of leukemia), and the management of transfusion therapy (e.g., cross-matching blood products, or plasmapheresis). Generally, clinical pathologists, except those with blood banking and coagulation expertise, do not interact directly with patients.

Anatomic pathology is a medical subspecialty concerned with the testing of tissue specimens or bodily fluids, typically by specialists referred to as anatomic pathologists, to interpret results and diagnose diseases or health conditions. Some anatomic pathologists perform postmortem examinations (autopsies). Typically, anatomic pathologists do not interact directly with patients, with the notable exception of the performance of fine needle aspiration biopsies.The Patient Care and Medical Investigation Essay

Laboratory scientists, historically referred to as medical technologists, may contribute to this process by preparing and collecting samples and performing tests. Especially for laboratory medicine, the ordering of diagnostic tests and the

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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of Radiology, 2010). Diagnostic testing may occur in successive rounds of information gathering, integration, and interpretation, as each round of information refines the working diagnosis. In many cases, diagnostic testing can identify a condition before it is clinically apparent; for example, coronary artery disease can be identified by an imaging study indicating the presence of coronary artery blockage even in the absence of symptoms.The Patient Care and Medical Investigation Essay

The primary emphasis of this section focuses on laboratory medicine, anatomic pathology, and medical imaging (see Box 2-2). However, there are many important forms of diagnostic testing that extend beyond these fields, and the committee’s conceptual model is intended to be broadly applicable. Aditional forms of diagnostic testing include, for example, screening tools used in making mental health diagnoses (SAMHSA and HRSA, 2015), sleep apnea testing, neurocognitive assessment, and vision and hearing testing.

interpretation of results are usually performed by the patient’s treating clinician, although pathologists have much to offer in these areas.

It is worth mentioning that with the advent of precision medicine, molecular diagnostic testing is not specifically aligned with either clinical or anatomic pathology (see Box 2-3).The Patient Care and Medical Investigation Essay

Medical imaging, also known as radiology, is a medical specialty that uses imaging technologies (such as X-ray, ultrasound, computed tomography [CT], magnetic resonance imaging [MRI], and positron emission tomography [PET]) to diagnose diseases and health conditions. For many conditions, it is also used to select and plan treatments, monitor treatment effectiveness, and provide longterm follow-up. Image interpretation is typically performed by radiologists or, for selected tests involving radioactive nuclides, nuclear medicine physicians. Technologists support the process by carrying out the imaging protocols. Most radiologists today have subspecialty training (e.g., in pediatric radiology or neuroradiology), while the remainder (about 18 percent) are generalists (Bluth et al., 2014). Specialists in other clinical disciplines, such as emergency medicine physicians and cardiologists, may be trained and credentialed to perform and interpret certain types of medical imaging. This can include imaging (such as ultrasound) to localize tissue targets during biopsy.The Patient Care and Medical Investigation Essay

A new subspecialty in radiology is molecular imaging, which involves the use of functional MRI techniques as well as MRI, PET/CT, or PET/MRI with molecular imaging probes. Several new molecular imaging probes have recently been approved for clinical use, and a growing number are entering clinical trials. The field of radiology also includes interventional radiology, which offers image-guided biopsy and diagnostic procedures as well as image-guided, minimally invasive treatments.

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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Although it was developed specifically for laboratory medicine, the brain-to-brain loop model is useful for describing the general process of diagnostic testing (Lundberg, 1981; Plebani et al., 2011). The model includes nine steps: test selection and ordering, sample collection, patient identification, sample transportation, sample preparation, sample analysis, result reporting, result interpretation, and clinical action (Lundberg, 1981). These steps occur during five phases of diagnostic testing: prepre-analytic, pre-analytic, analytic, post-analytic, and post-post-analytic phases. Errors related to diagnostic testing can occur in any of these five phases, but the analytic phase is the least susceptible to errors (Eichbaum et al., 2012; Epner et al., 2013; Laposata, 2010; Nichols and Rauch, 2013; Stratton, 2011) (see Chapter 3).The Patient Care and Medical Investigation Essay

The pre-pre-analytic phase, which involves clinician test selection and ordering, has been identified as a key point of vulnerability in the work process due to the large number and variety of available tests, which makes it difficult for nonspecialist clinicians to accurately select the correct test or series of tests (Hickner et al., 2014; Laposata and Dighe, 2007). The pre-analytic phase involves sample collection, patient identification, sample transportation, and sample preparation. During the analytic phase, the specimen is tested, examined, or both. Adequate performance in this phase depends on the correct execution of a chemical analysis or morphological examination (Hollensead et al., 2004), and the contribution to diagnostic errors at this step is small. The post-analytic phase includes the generation of results, reporting, interpretation, and follow-up. Ensuring accurate and timely reporting from the laboratory to the ordering clinician and patient is central to this phase. During the post-post-analytic phase, the ordering clinician, sometimes in consultation with pathologists, incorporates the test results into the patient’s clinical context, considers the probability of a particular diagnosis in light of the test results, and considers the harms and benefits of future tests and treatments, given the newly acquired information. Possible factors contributing to failure in this phase include an incorrect interpretation of the test result by the ordering clinician or pathologist and the failure by the ordering clinician to act on the test results: for example, not ordering a follow-up test or not providing treatment consistent with the test results (Hickner et al., 2014; Laposata and Dighe, 2007; Plebani and Lippi, 2011).The Patient Care and Medical Investigation Essay

The medical imaging work process parallels the work process described for pathology. There is a pre-pre-analytic phase (the selection and ordering of medical imaging), a pre-analytic phase (preparing the patient for imaging), an analytic phase (image acquisition and analysis), a post-analytic phase (the imaging results are interpreted and reported to the ordering clinician or the patient), and a post-post-analytic phase (the integration of results into the patient context and further action). The rel-

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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evant differences between the medical imaging and pathology processes include the nature of the examination and the methods and technology used to interpret the results.The Patient Care and Medical Investigation Essay

Laboratory Medicine and Anatomic Pathology

In 2008 a Centers for Disease Control and Prevention (CDC) report described pathology as an “essential element of the health care system,” stating that pathology is “integral to many clinical decisions, providing physicians, nurses, and other health care providers with often pivotal information for the prevention, diagnosis, treatment, and management of disease” (CDC, 2008, p. 19). Primary care clinicians order laboratory tests in slightly less than one third of patient visits (CDC, 2010; Hickner et al., 2014), and direct-to-patient testing is becoming increasingly prevalent (CDC, 2008). There are now thousands of molecular diagnostic tests available, and this number is expected to increase as the mechanisms of disease at the molecular level are better understood (CDC, 2008; Johansen Taber et al., 2014) (see Box 2-3).The Patient Care and Medical Investigation Essay

The task of selecting the appropriate diagnostic testing is challenging for clinicians, in part because of the sheer volume of choices. For example, Hickner and colleagues (2014) found that primary care clinicians report uncertainty in ordering laboratory medicine tests in approximately 15 percent of diagnostic encounters. Choosing the appropriate test requires understanding the patient’s history and current signs and symptoms, as well as having a sufficient suspicion or pre-test probability of a disease or condition (see section on probabilistic reasoning) (Pauker and Kassirer, 1975, 1980; Sox, 1986). The likelihood of disease is inherently uncertain in this step; for instance, the clinician’s patient population may not reflect epidemiological data, and the patient’s history can be incomplete or otherwise complicated. Advances in molecular diagnostic technologies and new diagnostic tests have introduced another layer of complexity. Many clinicians are struggling to keep up with the growing availability of such tests and have uncertainty about the best application of these tests in screening, diagnosis, and treatment (IOM, 2015a; Johansen Taber et al., 2014).The Patient Care and Medical Investigation Essay

Diagnostic tests have “operating parameters,” including sensitivity and specificity that are particular to the diagnostic test for a specific disorder (see section on probabilistic reasoning). Even if a test is performed correctly, there is a chance for a false positive or false negative result. Test interpretation involves reviewing numerical or qualitative (yes or no) results and combining those results with patient history, symptoms, and pretest disease likelihood. Test interpretation needs to be patient-specific and to consider information learned during the physical exam and the clinical history and interview. Several studies have highlighted test inter-

The President’s Precision Medicine Initiative highlights the growing interest in taking individual variability into account when defining disease, tailoring treatment, and improving prevention (NIH, 2015). This initiative hinges on recent advances in molecular and cellular biology, which have provided insights into the mechanisms of disease at the molecular level. These advances have contributed to the development of molecular diagnostic testing, which analyzes a patient’s biomarkers in the genome or proteome. Concurrently, the role of pathology has expanded from morphologic observations into comprehensive analyses using combined histological, immunohistochemical, and molecular evaluations.The Patient Care and Medical Investigation Essay

The use of molecular diagnostics is a rapidly developing area. Molecular diagnostic tests are being developed and used to diagnose and monitor disease, assess risk, inform whether a particular therapy is likely to be effective in a specific patient, and predict a patient’s response to therapy (AvaMedDx, 2013). Molecular diagnostic testing can identify a variety of specific genetic alterations relevant to diagnosis and treatment; molecular diagnostic techniques are also used to detect the genetic material of organisms causing infection. Panels of biomarkers are being developed into molecular diagnostic tests (omics-based tests) that are used to assess risk and inform treatment decisions, such as Oncotype DX and MammaPrint in breast cancer (IOM, 2012).

Molecular diagnostic testing is expected to improve patient management and outcomes. The potential advantages of molecular diagnostics include (1) providing earlier and more accurate diagnostic methods; (2) offering information about disease that will better tailor treatments to patients; (3) reducing the occurrence

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pretation errors, such as the misinterpretation of a false positive human immunodeficiency virus (HIV) screening test for a low-risk patient as indicative of HIV infection (Gigerenzer, 2013; Kleinman et al., 1998). In addition, test performance may only be characterized in a limited patient population, leading to challenges with generalizability (Whiting et al., 2004).The Patient Care and Medical Investigation Essay

The laboratories that conduct diagnostic testing are some of the most regulated and inspected areas in health care (see Table 2-1). Some of the relevant entities include The Joint Commission and other accreditors, the federal government, and various other organizations, such as the College of American Pathologists (CAP) and the American Society for Clinical Pathology. There are many ways in which quality is assessed. Examples include proficiency testing of clinical laboratory assays and pathologists (e.g., Pap smear proficiency testing), many of which are regulated under the Clinical Laboratory Improvement Amendments, and inter-laboratory The Patient Care and Medical Investigation Essay

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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of side effects from unnecessary treatments; (4) providing better tools to for the monitoring of patients for treatment success or disease recurrence; and (5) improving patient outcomes and quality of life.

However, the translation of molecular diagnostic technologies into clinical practice has been a complex and challenging endeavor. One major challenge is the development and rigorous evaluation of molecular diagnostic tests before their implementation in clinical practice. The development pathway is often timeconsuming, expensive, and uncertain. In addition, there are underdeveloped and inconsistent standards of evidence for evaluating the scientific validity of tests and a lack of appropriate study designs and analytical methods for these analyses (IOM, 2007, 2010, 2012). Ensuring that diagnostic tests have adequate analytical and clinical validity is critical to preventing diagnostic errors. For example, in 2005 the Centers for Disease Control and Prevention and the Food and Drug Administration issued a warning about potential diagnostic errors related to false positives caused by contamination in a Lyme disease test (Nelson et al., 2014). As molecular diagnostic testing becomes increasingly complex (such as the movement from single biomarker tests to omicsbased tests that rely on high-dimensional data and complex algorithms), there is considerable interest in ensuring their appropriate development and use (IOM, 2012). Molecular diagnostic testing presents many regulatory, clinical practice, and reimbursement challenges; an Institute of Medicine study is looking into these issues and is expected to release a report in 2016 (IOM, 2015b).The Patient Care and Medical Investigation Essay  For example, one regulatory issue is the oversight of laboratorydeveloped tests, an area that has been met with considerable controversy (see Table 2-1) (Evans and Watson, 2015; Sharfstein, 2015). A clinical practice issue is next generation sequencing, which may frequently identify new genetic variants with unknown implications for health outcomes (ACMG Board of Directors, 2012).

comparison programs (e.g., CAP’s Q-Probes, Q-Monitors, and Q-Tracks programs).

Medical Imaging

Medical imaging plays a critical role in establishing the diagnoses for innumerable conditions and it is used routinely in nearly every branch of medicine. The advancement of imaging technologies has improved the ability of clinicians to detect, diagnose, and treat conditions while also allowing patients to avoid more invasive procedures (European Society of Radiology, 2010; Gunderman, 2005). For many conditions (e.g., brain tumors), imaging is the only noninvasive diagnostic method available. The appropriate choice of imaging modality depends on the disease, organ, and specific clinical questions to be addressed. Computed tomography (CT) and magnetic resonance imaging (MRI) are first-line methods for as-

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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TABLE 2-1 Examples of Entities Involved in Quality Improvement and Oversight of Clinical and Anatomic Laboratories

Entity Role in Quality or Oversight
Centers for Disease Control and Prevention (CDC) The CDC performs research on laboratory testing processes, including quality improvement studies, and develops technical standards and laboratory practice guidelines (CDC, 2014).The Patient Care and Medical Investigation Essay The CDC also manages the Clinical Laboratory Improvement Advisory Committee (CLIAC), a body that offers guidance to the federal government on quality improvement in the clinical laboratory and revising Clinical Laboratory Improvement Amendments (CLIA) standards.
Centers for Medicare & Medicaid Services (CMS) CMS regulates laboratories under CLIA (CMS, 2015b). To ensure CLIA compliance, laboratories undergo review of results reporting, laboratory personnel credentialing (i.e., competency assessment), quality control efforts, and procedure documentation. Laboratories are also required to perform proficiency testing (PT), a process in which a laboratory receives an unknown sample to test and report the findings back to the PT program, which evaluates the laboratory’s performance.
CMS grants states or accreditation organizations the authority to deem a laboratory as CLIA-compliant. In most cases the laboratory is deemed compliant by virtue of being accredited by the accreditation organization. Accreditation organizations with deeming authority for CLIA include AABB, the American Association for Laboratory Accreditation, the American Society for Histocompatibility and Immunogenics, COLA, the College of American Pathologists, the Healthcare Facilities Accreditation Program, and The Joint Commission (CMS, 2014).The Patient Care and Medical Investigation Essay
Food and Drug Administration (FDA) FDA reviews and assesses the safety, efficacy, and intended use of in vitro diagnostic tests (IVDs) (FDA, 2014a). FDA assesses the analytical validity (i.e., analytical specificity and sensitivity, accuracy, and precision) and clinical validity (i.e., the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition), and it develops rules and guidance for CLIA complexity categorization. One subset of IVDs, laboratory developed tests (LDTs), has been granted enforcement discretion from FDA; in 2014 FDA stated its intent to begin regulating LDTs (FDA, 2014b).
American Academy of Family Physicians (AAFP) The AAFP offers a number of CMS-approved PT programs (AAFP, 2015).
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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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Entity Role in Quality or Oversight
American Society for Clinical Pathology (ASCP) ASCP certifies medical laboratory professionals. ASCP also manages a CMS-approved PT program for gynecologic cytology (ASCP, 2014).
College of American Pathologists (CAP) CAP accreditation ensures the safety and quality of laboratories and satisfies CLIA requirements. CAP also offers an inter-laboratory peer PT program (CAP, 2013, 2015). This program includes
Q-Tracks: a continuous quality monitoring process
Q-Probes: a short-term study that provides a time slice assessment of performance The Patient Care and Medical Investigation Essay
Q-Monitors: customized programs that address process-, outcome-, and structure-oriented quality assurance issues
Healthcare Facilities Accreditation Program (HFAP) HFAP accreditation ensures the safety and quality of laboratories and satisfies CLIA requirements (HFAP, 2015).
The Joint Commission The Joint Commission accreditation ensures the safety and quality of laboratories and satisfies CLIA requirements (The Joint Commission, 2015).
sessing conditions of the central and peripheral nervous system, while for musculoskeletal and a variety of other conditions, X-ray and ultrasound are often employed first because of their relatively low cost and ready availability, with CT and MRI being reserved as problem-solving modalities. CT procedures are frequently used to assess and diagnose cancer, circulatory system diseases and conditions, inflammatory diseases, and head and internal organ injuries. A majority of MRI procedures are performed on the spine, brain, and musculoskeletal system, although usage for the breast, prostate, abdominal, and pelvic regions is rising (IMV, 2014).

Medical imaging is characterized not just by the increasingly precise anatomic detail it offers but also by an increasing capacity to illuminate biology. For example, magnetic resonance spectroscopic imaging has allowed the assessment of metabolism, and a growing number of other MRI sequences are offering information about functional characteristics, such as blood perfusion or water diffusion. In addition, several new tracers for The Patient Care and Medical Investigation Essay

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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molecular imaging with PET (typically as PET/CT) have recently been approved for clinical use, and more are undergoing clinical trials, while PET/MRI was recently introduced to the clinical setting. Functional and molecular imaging data may be assessed qualitatively, quantitatively, or both. Although other forms of diagnostic testing can identify a wide array of molecular markers, molecular imaging is unique in its capacity to noninvasively show the locations of molecular processes in patients, and it is expected to play a critical role in advancing precision medicine, particularly for cancers, which often demonstrate both intra- and intertumoral biological heterogeneity (Hricak, 2011).

The growing body of medical knowledge, the variety of imaging options available, and the regular increases in the amounts and kinds of data that can be captured with imaging present tremendous challenges for radiologists, as no individual can be expected to achieve competency in all of the imaging modalities. General radiologists continue to be essential in certain clinical settings, but extended training and sub-specialization are often necessary for optimal, clinically relevant image interpretation, as is involvement in multidisciplinary disease management teams. Furthermore, the use of structured reporting templates tailored to specific examinations can help to increase the clarity, thoroughness, and clinical relevance of image interpretation (Schwartz et al., 2011).

Like other forms of diagnostic testing, medical imaging has limitations. Some studies have found that between 20 and 50 percent of all advanced imaging results fail to provide information that improves patient outcome, although these studies do not account for the value of negative imaging results in influencing decisions about patient management (Hendee et al., 2010). Imaging may fail to provide useful information because of modality sensitivity and specificity parameters; for example, the spatial resolution of an MRI may not be high enough to detect very small abnormalities. Inadequate patient education and preparation for an imaging test can also lead to suboptimal imaging quality that results in diagnostic error.The Patient Care and Medical Investigation Essay

Perceptual or cognitive errors made by radiologists are a source of diagnostic error (Berlin, 2014; Krupinski et al., 2012). In addition, incomplete or incorrect patient information, as well as insufficient sharing of patient information, may lead to the use of an inadequate imaging protocol, an incorrect interpretation of imaging results, or the selection of an inappropriate imaging test by a referring clinician. Referring clinicians often struggle with selecting the appropriate imaging test, in part because of the large number of available imaging options and gaps in the teaching of radiology in medical schools. Although consensus-based guidelines (e.g., the various “appropriateness criteria” published by the American College of Radiology [ACR]) are available to help select imaging tests for many

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Suggested Citation:”2 The Diagnostic Process.” National Academies of Sciences, Engineering, and Medicine. 2015. Improving Diagnosis in Health Care. Washington, DC: The National Academies Press. doi: 10.17226/21794.×
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conditions, these guidelines are often not followed. The use of clinical decision support systems at the point of care as well as direct consultations with radiologists have been proposed by the ACR as methods for improving imaging test selection (Allen and Thorwarth, 2014).

There are several mechanisms for ensuring the quality of medical imaging. The Mammography Quality Standards Act (MQSA)—overseen by the Food and Drug Administration—was the first government-mandated accreditation program for any type of medical facility; it was focused on X-ray imaging for breast cancer. MQSA provides a general framework for ensuring national quality standards in facilities that perform screening mammography (IOM, 2005). MQSA requires all personnel at facilities to meet initial qualifications, to demonstrate continued experience, and to complete continuing education. The Patient Care and Medical Investigation Essay MQSA addresses protocol selection, image acquisition, interpretation and report generation, and the communication of results and recommendations. In addition, it provides facilities with data on diagnostic performance that can be used for benchmarking, self-monitoring, and improvement. MQSA has decreased the variability in mammography performed across the United States and improved the quality of care (Allen and Thorwarth, 2014). However, the ACR noted that MQSA is complex and specified in great detail, which makes it inflexible, leading to administrative burdens and the need for extensive training of staff for implementation (Allen and Thorwarth, 2014). It also focuses on only one medical imaging modality in one disease area; thus, it does not address newer screening technologies (IOM, 2005). In addition, the Medicare Improvements for Patients and Providers Act (MIPPA)3 requires that private outpatient facilities that perform CT, MRI, breast MRI, nuclear medicine, and PET exams be accredited. The requirements include personnel qualifications, image quality, equipment performance, safety standards, and quality assurance and quality control (ACR, 2015a). There are four CMS-designated accreditation organizations for medical imaging: ACR, the Intersocietal Accreditation Commission, The Joint Commission, and RadSite (CMS, 2015a). MIPPA also mandated that, beginning in 2017, ordering clinicians will be required to consult appropriateness criteria to order advanced medical imaging procedures, and the act called for a demonstration project evaluating clinician compliance with appropriateness criteria (Timbie et al., 2014). In addition to these mandated activities, societies such as ACR and the Radiological Society of North America (RSNA) provide quality improvement programs and resources (ACR, 2015b; RSNA, 2015). The Patient Care and Medical Investigation Essay