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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). 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 chapter describes important considerations in the diagnostic process, such as the roles of diagnostic uncertainty and time. 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.To help frame and organize its work, the committee developed a conceptual model to illustrate the diagnostic process (see ). 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 ). 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 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 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. 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.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. 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.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.Clinical History and InterviewAcquiring 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.
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 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. 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.
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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 ), may lead to an incomplete picture of a patient’s relevant history and current signs and symptoms.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. 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).Physical ExamThe 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.Due to the growing emphasis on diagnostic testing, there are concerns that physical exam skills have been underemphasized in current. 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).Diagnostic TestingOver the past 100 years, diagnostic testing has become a critical feature of standard medical practice (Berger, 1999; European Society. 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. 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 primary emphasis of this section focuses on laboratory medicine, anatomic pathology, and medical imaging (see ). 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 ).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.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.
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. 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.Laboratory Medicine and Anatomic PathologyIn 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.
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 ).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).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 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 occurrencepretation 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 laboratories that conduct diagnostic testing are some of the most regulated and inspected areas in health care (see ). 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. 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). For example, one regulatory issue is the oversight of laboratorydeveloped tests, an area that has been met with considerable controversy (see ) (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 ImagingMedical 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.
EntityRole in Quality or OversightCenters 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 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).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.
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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). EntityRole in Quality or OversightAmerican 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). 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. 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. 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) 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).Public Law 110-275 (July 15, 2008). Referral and ConsultationClinicians may refer to or consult with other clinicians (formally or informally) to seek additional expertise about a patient’s health problem. The consult may help to confirm or reject the working diagnosis or may provide information on potential treatment options. If a patient’s health problem is outside a clinician’s area of expertise, he or she can refer the patient to a clinician who holds more suitable expertise.
Clinicians can also recommend that the patient seek a second opinion from another clinician to verify their impressions of an uncertain diagnosis or if they believe that this would be helpful to the patient. Many groups raise awareness that patients can obtain a second opinion on their own (AMA, 1996; CMS, 2015c; PAF, 2012).
Diagnostic consultations can also be arranged through the use of integrated practice units or diagnostic management teams (Govern, 2013; Porter, 2010; see ).The committee elaborated on several aspects of the diagnostic process which are discussed below, including. diagnostic uncertainty. time. population trends. diverse populations and health disparities. mental healthDiagnostic UncertaintyOne of the complexities in the diagnostic process is the inherent uncertainty in diagnosis.
As noted in the committee’s conceptual model of the diagnostic process, an overarching question throughout the process is whether sufficient information has been collected to make a diagnosis. This does not mean that a diagnosis needs to be absolutely certain in order to initiate treatment. Kassirer concluded that. Tainty, but rather to reduce the level of diagnostic uncertainty enough to make optimal therapeutic decisions. (Kassirer, 1989, p. 1489)Thus, the probability of disease does not have to be equal to one (diagnostic certainty) in order for treatment to be justified (Pauker and Kassirer, 1980). The decision to begin treatment based on a working diagnosis is informed by: (1) the degree of certainty about the diagnosis; (2) the harms and benefits of treatment; and (3) the harms and benefits of further information-gathering activities, including the impact of delaying treatment.The risks associated with diagnostic testing are important considerations when conducting information-gathering activities in the diagnostic process.
While underuse of diagnostic testing has been a long-standing concern, overly aggressive diagnostic strategies have recently been recognized for their risks (Zhi et al., 2013) (see ). Overuse of diagnostic testing has been partially attributed to clinicians’ fear of missing something important and intolerance of diagnostic uncertainty: “I am far more concerned about doing too little than doing too much. It’s the scan, the test, the operation that I should have done that sticks with me—sometimes for years. By contrast, I can’t remember anyone I sent for an unnecessary CT scan or operated on for questionable reasons a decade ago” (Gawande, 2015). However, there is growing recognition that overly aggressive diagnostic pursuits are putting patients at greater risk for harm, and they are not improving diagnostic certainty (Kassirer, 1989; Welch, 2015).When considering diagnostic testing options, the harm from the procedure itself needs to be weighed against the potential information that could be gained.
For some patients, the risk of invasive diagnostic testing may be inappropriate due to the risk of mortality or morbidity from the test itself (such as cardiac catheterization or invasive biopsies). In addition, the risk for harm needs to take into account the cascade of diagnostic testing and treatment decisions that could stem from a diagnostic test result. Included in these assessments are the potential for false positives and ambiguous or slightly abnormal test results that lead to further diagnostic testing or unnecessary treatment.There are some cases in which treatment is initiated even though there is limited certainty in a working diagnosis. For example, an individual who has been exposed to a tick bite or HIV may be treated with prophylactic antibiotics or antivirals, because the risk of treatment may be felt to be smaller than the risk of harm from tick-borne diseases or HIV infection. Clinicians sometimes employ empiric treatment strategies—or the provision of treatment with a very uncertain diagnosis—and use a patient’s response to treatment as an information-gathering activity to help arrive at a working diagnosis.
However, it is important to note. That response rates to treatment can be highly variable, and the failure to respond to treatment does not necessarily reflect that a diagnosis is incorrect. Nor does improvement in the patient’s condition necessarily validate that the treatment conferred this benefit and, therefore, that the empirically tested diagnosis was in fact correct. A treatment that is beneficial for some patients might not be beneficial for others with the same condition (Kent and Hayward, 2007), hence the interest in precision medicine, which is hoped to better tailor therapy to maximize efficacy and minimize toxicity (Jameson and Longo, 2015). In addition, there are isolated cases where the morbidity and the mortality of a diagnostic procedure and the likelihood of disease is sufficiently high that significant therapy has been given empirically. Moroff and Pauker (1983) described a decision analysis in which a 90-year-old practicing lawyer with a new 1.5 centimeter lung nodule was deemed to have a sufficiently high risk for mortality from lung biopsy and high likelihood of malignancy that the radiation oncologists felt comfortable treating the patient empirically for suspected lung cancer.TimeOf major importance in the diagnostic process is the element of time. Most diseases evolve over time, and there can be a delay between the onset of disease and the onset of a patient’s symptoms; time can also elapse before a patient’s symptoms are recognized as a specific diagnosis (Zwaan and Singh, 2015).
Some diagnoses can be determined in a very short time frame, while months may elapse before other diagnoses can be made. This is partially due to the growing recognition of the variability and complexity of disease presentation. Similar symptoms may be related to a number of different diagnoses, and symptoms may evolve in different ways as a disease progresses; for example, a disease affecting multiple organs may initially involve symptoms or signs from a single organ. The thousands of different diseases and health conditions do not present in thousands of unique ways; there are only a finite number of symptoms with which a patient may present. At the outset, it can be very difficult to determine which particular diagnosis is indicated by a particular combination of symptoms, especially if symptoms are nonspecific, such as fatigue. Diseases may also present atypically, with an unusual and unexpected constellation of symptoms (Emmett, 1998).Adding to the complexity of the time-dependent nature of the diagnostic process are the numerous settings of care in which diagnosis occurs and the potential involvement of multiple settings of care within a single diagnostic process.
Henriksen and Brady noted that this process—for patients, their families, and clinicians alike—can often feel like “a disjointed. Journey across confusing terrain, aided or impeded by different agents, with no destination in sight and few landmarks along the way” (Henriksen and Brady, 2013, p.
Ii2).Some diagnoses may be more important to establish immediately than others. These include diagnoses that can lead to significant patient harm if not recognized, diagnosed, and treated early, such as anthrax, aortic dissection, and pulmonary embolism.
Sometimes making a timely diagnosis relies on the fast recognition of symptoms outside of the health care setting (e.g., public awareness of stroke symptoms can help improve the speed of receiving medical help and increase the chances of a better recovery) (National Stroke Association, 2015). In these cases, the benefit of treating the disease promptly can greatly exceed the potential harm from unnecessary treatment. Consequently, the threshold for ordering diagnostic testing or for initiating treatment becomes quite low for such health problems (Pauker and Kassirer, 1975, 1980).
In other cases, the potential harm from rapidly and unnecessarily treating a diagnosed condition can lead to a more conservative (or higher-threshold) approach in the diagnostic process.Population TrendsPopulation trends, such as the aging of the population, are adding significant complexity to the diagnostic process and require clinicians to consider such complicating factors in diagnosis as comorbidity, polypharmacy and attendant medication side effects, as well as disease and medication interactions (IOM, 2008, 2013b). Diagnosis can be especially challenging in older patients because classic presentations of disease are less common in older adults (Jarrett et al., 1995). For example, infections such as pneumonia or urinary tract infections often do not present in older patients with fever, cough, and pain but rather with symptoms such as lethargy, incontinence, loss of appetite, or disruption of cognitive function (Mouton et al., 2001). Acute myocardial infarction (MI) may present with fatigue and confusion rather than with typical symptoms such as chest pain or radiating arm pain (Bayer et al., 1986; Qureshi et al., 2000; Rich, 2006). Sensory limitations in older adults, such as hearing and vision impairments, can also contribute to challenges in making diagnoses (Campbell et al., 1999). Physical illnesses often present with a change in cognitive status in older individuals without dementia (Mouton et al., 2001). In older adults with mild to moderate dementia, such illnesses can manifest with worsening cognition.
Older patients who have multiple comorbidities, medications, or cognitive and functional impairments are more likely to have atypical disease presentations, which may increase the risk of experiencing diagnostic errors (Gray-Miceli, 2008). Diverse Populations and Health DisparitiesCommunicating with diverse populations can also contribute to the complexity of the diagnostic process. Language, health literacy, and cultural barriers can affect clinician–patient encounters and increase the potential for challenges in the diagnostic process (Flores, 2006; IOM, 2003; The Joint Commission, 2007).
There are indications that biases influence diagnosis; one well-known example is the differential referral of patients for cardiac catheterization by race and gender (Schulman et al., 1999). In addition, women are more likely than men to experience a missed diagnosis of heart attack, a situation that has been partly attributed to real and perceived gender biases, but which may also be the result of physiologic differences, as women have a higher likelihood of presenting with atypical symptoms, including abdominal pain, shortness of breath, and congestive heart failure (Pope et al., 2000).Mental HealthMental health diagnoses can be particularly challenging. Mental health diagnoses rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM); each diagnosis in the DSM includes a set of diagnostic criteria that indicate the type and length of symptoms that need to be present, as well as the symptoms, disorders, and conditions that cannot be present, in order to be considered for a particular diagnosis (APA, 2015). Compared to physical diagnoses, many mental health diagnoses rely on patient reports and observation; there are few biological tests that are used in such diagnoses (Pincus, 2014).
A key challenge can be distinguishing physical diagnoses from mental health diagnoses; sometimes physical conditions manifest as psychiatric ones, and vice versa (Croskerry, 2003a; Hope et al., 2014; Pincus, 2014; Reeves et al., 2010). In addition, there are concerns about missing psychiatric diagnoses, as well as overtreatment concerns (Bor, 2015; Meyer and Meyer, 2009; Pincus, 2014). For example, clinician biases toward older adults can contribute to missed diagnoses of depression, because it may be perceived that older adults are likely to be depressed, lethargic, or have little interest in interactions. Patients with mental health–related symptoms may also be more vulnerable to diagnostic errors, a situation that is attributed partly to clinician biases; for example, clinicians may disregard symptoms in patients with previous diagnoses of mental illness or substance abuse and attribute new physical symptoms to a psychological cause (Croskerry, 2003a). Individuals with health problems that are difficult to diagnose or those who have chronic pain may also be more likely to receive psychiatric diagnoses erroneously. Accurate, timely, and patient-centered diagnosis relies on proficiency in clinical reasoning, which is often regarded as the clinician’s quintessential competency. Clinical reasoning is “the cognitive process that is necessary to evaluate and manage a patient’s medical problems” (Barrows, 1980, p.
Understanding the clinical reasoning process and the factors that can impact it are important to improving diagnosis, given that clinical reasoning processes contribute to diagnostic errors (Croskerry, 2003a; Graber, 2005). Health care professionals involved in the diagnostic process have an obligation and ethical responsibility to employ clinical reasoning skills: “As an expanding body of scholarship further elucidates the causes of medical error, including the considerable extent to which medical errors, particularly in diagnostics, may be attributable to cognitive sources, insufficient progress in systematically evaluating and implementing suggested strategies for improving critical thinking skills and medical judgment is of mounting concern” (Stark and Fins, 2014, p. Clinical reasoning occurs within clinicians’ minds (facilitated or impeded by the work system) and involves judgment under uncertainty, with a consideration of possible diagnoses that might explain symptoms and signs, the harms and benefits of diagnostic testing and treatment for each of those diagnoses, and patient preferences and values.The current understanding of clinical reasoning is based on the dual process theory, a widely accepted paradigm of decision making. The dual process theory integrates analytical and non-analytical models of decision making (see ). Analytical models (slow system 2) involve a conscious, deliberate process guided by critical thinking (Kahneman, 2011).
Nonanalytical models (fast system 1) involve unconscious, intuitive, and automatic pattern recognition (Kahneman, 2011).Fast system 1 (nonanalytical, intuitive) automatic processes require very little working memory capacity. They are often triggered by stimuli or result from overlearned associations or implicitly learned activities. Examples of system 1 processes include the ability to recognize human faces (Kanwisher and Yovel, 2006), the diagnosis of Lyme disease from a bull’s-eye rash, or decisions based on heuristics (mental shortcuts), intuition, or repeated experiences.In contrast, slow system 2 (reflective, analytical) processing places a heavy load on working memory and involves hypothetical and counterfactual reasoning (Evans and Stanovich, 2013; Stanovich and Toplak, 2012). System 2 processing requires individuals to generate mental modelsThe term “system 1” is an oversimplification because it is unlikely there is a single cognitive or neural system responsible for all system 1 cognitive processes.
Must-see live act!My wife and I saw them live in a small club in Atlanta during a honeymoon trip back in the summer of '99. We got Fight Songs and played it to death in our rented green Oldsmobile Bravada while driving throughout the South.
She has been smitten with Rhett ever since.I won't hold that against him. Wonderful lyricist, great hooks and energy and a fantastically ragged, but extremely fun live act. All of their albums are worthwhile, but I am most fond of their powerpop albums, particularly Fight Songs and Satellite Rides.Prefer the band albums to Rhett solo, but his records aren't bad.
First major label one was a little overproduced, but I'm a big Jon Brion fan, so that's fine. By the way, he covered Brion's 'I Believe She's Lying' on that album.Another fan of the band: esteemed music critic Robert Christgau.
Click to expand.I caught them maybe five years ago when they were getting back into things after Rhett's solo diversion. The vibe wasn't good, they didn't seem to want to be there, and there were obvious tensions in the band, who cut their set by about 1/3, based on the stage setlist. Best thing about ending their show early was I got to pop into the small room of the club and catch Dr. Dog, who I had previously dismissed based on their stupid name, and Delta Spirit, who I've grown to love.Still dig the '97s, I think I just caught them on a bad night. Click to expand.I didn't even know Drag It Up was on vinyl until I saw it at my local store a couple of months ago.
The completist in me wants it, but I didn't want to spend $30 for what I feel is their weakest (and muddiest sounding) album. I'd say the chances of it being all analog are pretty good.
Both volumes of The Grand Theater appear to be on vinyl too (through their online store).I definitely need to get those.I have the Too Far to Care anniversary release and it sounds awesome (especially for colored vinyl). The demo vinyl is decent too.
If you can get Blame It On Gravity on vinyl, do it! Mastered by Kevin Gray and sounds really, really nice.
I'll also second TerryB and say the Wreck Your Life deluxe is good too. For anyone interested, the Old 97's are doing something cool with the vinyl release of their new album, Most Messed Up.
They made 500 limited edition 'Bootleg' copies of the album, in a plain white 'messed up' package and on orange vinyl, available at indie stores only. If you buy one, and post a picture of yourself with it on Facebook, Instagram or Twitter, along with the tags #mostmessedup and #shopindie, you will be entered into a chance to win an autographed copy of the regular version of the album. More details below. Btw, I got #34 of 500, and yes, the album does come with a download card where you can get the album in either wav or mp3 format as a bonus.Oh, and right now, you can also still pick up a yellow vinyl copy of They Made A Monster:The a Too Far To Care Demos from Omnivore Recordings really cheap as part of their Spring Fling sale. More details on that and other albums they have for sale at this link.
I didn't even know Drag It Up was on vinyl until I saw it at my local store a couple of months ago. The completist in me wants it, but I didn't want to spend $30 for what I feel is their weakest (and muddiest sounding) album.
I'd say the chances of it being all analog are pretty good. Both volumes of The Grand Theater appear to be on vinyl too (through their online store).I definitely need to get those.I have the Too Far to Care anniversary release and it sounds awesome (especially for colored vinyl). The demo vinyl is decent too. If you can get Blame It On Gravity on vinyl, do it! Mastered by Kevin Gray and sounds really, really nice. I'll also second TerryB and say the Wreck Your Life deluxe is good too.
For anyone interested, the Old 97's are doing something cool with the vinyl release of their new album, Most Messed Up. They made 500 limited edition 'Bootleg' copies of the album, in a plain white 'messed up' package and on orange vinyl, available at indie stores only. If you buy one, and post a picture of yourself with it on Facebook, Instagram or Twitter, along with the tags #mostmessedup and #shopindie, you will be entered into a chance to win an autographed copy of the regular version of the album. More details below.
Btw, I got #34 of 500, and yes, the album does come with a download card where you can get the album in either wav or mp3 format as a bonus.Oh, and right now, you can also still pick up a yellow vinyl copy of They Made A Monster:The a Too Far To Care Demos from Omnivore Recordings really cheap as part of their Spring Fling sale. More details on that and other albums they have for sale at this link. Click to expand.I disagree about Rhett's solo albums, somewhat. The first TWO are great, but after 2006's The Believer, then yes I do agree they went downhill from there.
But, I think it was because instead of saving all his best ideas for his solo stuff - as he did with the first two - he started using that material for the the Old 97's, again. My proof for this is that the two records he did with the band in 2004, Drag It Up, and 2008, Blame It On Gravity, were both kind of meh.
These were the albums which immediately followed each of his first two solo albums. Then you get the s/t solo album in 2009, which I, surprisingly, found extremely dull - yet that was followed up by two great Old 97's albums in The Grand Theater, Vol One (2010), and The Grand Theater, Vol Two (2011).
Rhett's 2012 solo album The Dreamer, again very dull, but this new Old 97's album - fantastic.