The Trial of Ascertaining Individual Preferences for Loved Ones' Role in End-of-Life Decisions (TAILORED) Study: A Randomized Controlled Trial to Improve Surrogate Decision Making.

CONTEXT: Patients with terminal illnesses often require surrogate decision makers. Prior research has demonstrated high surrogate stress, and that despite standards promoting substituted judgment, most patients do not want their surrogates to make pure substituted judgments for them. It is not known how best to help loved ones fulfill the surrogate role. OBJECTIVES: To test the effectiveness of an intervention to help surrogate decision makers. METHODS: One hundred sixty-six patients (41% with amyotrophic lateral sclerosis and 59% with gastrointestinal cancers) and their surrogates at two university medical centers were randomized to an intensive nurse-directed discussion of the end-of-life decision control preferences of the patient (TAILORED) or a discussion of nutrition (CONTROL); 163 completed baseline interviews and underwent the intervention. RESULTS: Twelve patients died during follow-up and 137 dyads completed the study. Post-intervention, using all available data, TAILORED patients and surrogates became more likely to endorse mutual surrogate decision making, that is, a balance of their own wishes and what the surrogate thinks best (adjusted odds compared with baseline for patients = 1.78, P = 0.04; adjusted odds for surrogates = 2.05, P = 0.03). CONTROL patients became 40% less likely to endorse mutual surrogate decision making (P = 0.08), and CONTROL surrogates did not change significantly from baseline (adjusted odds = 1.44, P = 0.28). Stress levels decreased for TAILORED surrogates (impact of events scale = 23.1 ± 14.6 baseline, 20.8 ± 15.3 f/u, P = 0.046), but not for CONTROL (P = 0.85), and post-intervention stress was lower for TAILORED than CONTROL (P = 0.04). Surrogates' confidence was uniformly high at baseline and did not change. Caregiver burden (Zarit) increased from 12.5 ± 6.5 to 14.7 ± 8.1 for TAILORED (P < 0.01), while not changing for CONTROL, yet satisfaction with involvement in decision making was higher at follow-up for TAILORED than for CONTROL (71% vs. 52%, P = 0.03). CONCLUSION: TAILORED patients and surrogates who completed the study adopted a more mutual decision-making style, balancing their own wishes with what the surrogate thinks would be best for them. Surrogates reported less stress and more satisfaction. Confidence was high at baseline and did not change. There was a modest increase in caregiver burden. These findings suggest that interventions like TAILORED might positively impact surrogate decision making.

Pulmonary Infarction: In the Beginning: The Natural History of Pulmonary Infarction.

BACKGROUND: Massive pulmonary emboli can cause an abrupt onset of symptoms simultaneous with large pulmonary artery occlusions. In contrast, the temporal relationship between pulmonary vascular occlusion by smaller emboli and the development of symptoms of pulmonary infarction is unknown. We describe the time interval between embolization and the onset of clinical symptoms and signs compatible with pulmonary infarction. METHODS: We examined the records of 56 patients with hereditary hemorrhagic telangiectasia (HHT) who underwent therapeutic balloon embolization of pulmonary arteriovenous malformation (PAVM) in a single center after noting that some of them experienced symptoms and signs compatible with pulmonary infarction. Because both the times of embolization and the onset of clinical symptoms were documented in medical records, we were able to calculate the time interval between embolic occlusion of vessels and the onset of symptoms. RESULTS: The records of 56 patients who underwent therapeutic embolization for HHT were examined. Five patients experienced a single episode of pleuritic pain postembolization, and one patient experienced episodes of pleuritic pain after each of two separate embolization procedures. Four of these pleuritic pain events evolved into a complex compatible with pulmonary infarction. The time intervals between embolization and the onset of pleuritic pain in those experiencing the infarction symptoms and signs were 24 hours, 48 ± 4 hours, 65 hours, and 67 hours, respectively. CONCLUSIONS: The clinically silent time interval between embolization of a pulmonary artery and the onset of symptoms and signs compatible with lung infarction is 24 hours or greater.

Patient and caregiver characteristics related to completion of advance directives in terminally ill patients.

OBJECTIVE: There is a growing body of literature describing the characteristics of patients who plan for the end of life, but little research has examined how caregivers influence patients' advance care planning (ACP). The purpose of this study was to examine how patient and caregiver characteristics are associated with advance directive (AD) completion among patients diagnosed with a terminal illness. We defined AD completion as having completed a living will and/or identified a healthcare power of attorney. METHOD: A convenience sample of 206 caregiver-patient dyads was included in the study. All patients were diagnosed with an advanced life-limiting illness. Trained research nurses administered surveys to collect information on patient and caregiver demographics (i.e., age, sex, race, education, marital status, and individual annual income) and patients' diagnoses and completion of AD. Multivariate logistic regression was employed to model predictors for patients' AD completion. RESULTS: Over half of our patient sample (59%) completed an AD. Patients who were older, diagnosed with amyotrophic lateral sclerosis, and with a caregiver who was Caucasian or declined to report an income level were more likely to have an AD in place. SIGNIFICANCE OF RESULTS: Our results suggest that both patient and caregiver characteristics may influence patients' decisions to complete an AD at the end of life. When possible, caregivers should be included in advance care planning for patients who are terminally ill.

The Clinical Significance of Collateral Ventilation.

Oxygen delivery and carbon dioxide removal being critical to cell survival, mammals have developed collateral vascular and ventilation systems to ensure tissue viability. Collateral ventilation, defined as ventilation of alveoli via pathways that bypass normal airways, is present in humans and many other species. The presence of collateral ventilation can be beneficial in certain disease states, whereas its relative absence can predispose to other diseases. These well defined anatomical pathways contribute little to ventilation in normal humans, but modulate ventilation perfusion imbalance in a variety of diseases, including obstructive diseases, such as asthma and emphysema. These pathways can be affected by pharmaceuticals and inhaled gas compositions. The middle lobe and lingula, constrained by their isolated, segmental anatomy, have reduced collateral ventilation, which predisposes them to disease. Recently, attempts to improve the quality of life of patients with emphysema, by performing nonsurgical lung volume reduction via use of endobronchial valves, have led to mixed results, because the role of collateral ventilation in the success or failure of the procedure was not initially appreciated. This review describes the anatomical pathways of collateral ventilation, their physiology and relationship to disease states, their modulatory effects on gas exchange, treatment considerations, and their effect on diagnostic procedures.

Occupational Asthma Due to Inhalation of Aerosolized Lipophilic Coating Materials.

We present a case of onset of severe asthma in a 59-year-old patient who worked in an aerospace plant. He was noted to have wheezing on exam and obstruction on PFTs. Review of his occupational history revealed exposure to lipophilic industrial compounds. We outline the radiographic and histologic findings that were found in the patient, and discuss occupational asthma due to inhalation of lipophilic compounds.

Hemodialysis catheter-associated superior vena cava syndrome and pulmonary embolism: a case report and review of the literature.

BACKGROUND: Hemodialysis (HD) catheters are frequently inserted into the superior vena cava (SVC), and can lead to thrombotic complications. However, to our knowledge, HD catheter-related thrombosis leading to subsequent SVC syndrome, bacteremia, and pulmonary emboli has not been described. CASE PRESENTATION: A 28-year-old dialysis-dependent woman with IgA nephropathy developed facial swelling, head pressure, headache, nausea, dizziness and fever 6 weeks after right internal jugular (IJ) HD catheter placement. Chest and neck imaging demonstrated a non-occlusive thrombus surrounding the HD catheter and extending from the SVC to the junction of the right IJ and right subclavian veins, confirming thrombosis-associated SVC syndrome. Intravenous (IV) anticoagulation was initiated, as well as IV vancomycin for Staphylococcus epidermidis bacteremia. Despite prompt intravenous anticoagulation, 9 and 12 days after initial presentation she developed catheter-associated pulmonary embolism (PE) and PE-associated pulmonary infarction, respectively. Hypercoagulable workup was negative. The HD catheter was eventually replaced, HD resumed, and the patient was transitioned from intravenous to oral anticoagulation and discharged. Nine months later, she underwent successful renal transplantation. CONCLUSION: SVC syndrome and pulmonary embolism are potential consequences of HD catheter-related thrombosis. Given the frequency of HD catheter placement, physicians should be aware of these potential complications in any patient with HD catheter-related thrombosis.

Bronchiolitis obliterans organizing pneumonia following a jalapeño grease fire.

Bronchiolitis obliterans organizing pneumonia (BOOP) is an inflammatory lung disease characterized by granulation tissue in the respiratory bronchioles, alveolar ducts and alveoli. BOOP can be caused by a number of etiologies including infection, toxic inhalation, medications, radiation, and collagen vascular disease, or it can be idiopathic. We report here a case of BOOP following inhalational exposure to a jalapeño grease fire. Capsaicin and other jalapeño-derived compounds are known causes of epithelial damage and airway inflammation but to our knowledge have never been implicated in the development of BOOP. This case adds to the growing list of exposures associated with BOOP and highlights the importance of taking a thorough exposure history in patients with lung injury of unknown etiology.

The community speaks: understanding ethical values in allocation of scarce lifesaving resources during disasters.

INTRODUCTION: Pandemic influenza or other crises causing mass respiratory failure could easily overwhelm current North American critical care capacity. This threat has generated large-scale federal, state, and local efforts to prepare for a public health disaster. Few, however, have systematically engaged the public regarding which values are most important in guiding decisions about how to allocate scarce healthcare resources during such crises. METHODS: The aims of this pilot study were (1) to test whether deliberative democratic methods could be used to promote engaged discussion about complex, ethically challenging healthcare-related policy issues and (2) to develop specific deliberative democratic procedures that could ultimately be used in a statewide process to inform a Maryland framework for allocating scarce healthcare resources during disasters. Using collaboratively developed focus group materials and multiple metrics for assessing outcomes, we held 5-hour pilot community meetings with a combined total of 68 community members in two locations in Maryland. The key outcomes used to assess the project were (1) the comprehensibility of the background materials and ethical principles, (2) the salience of the ethical principles, (3) the perceived usefulness of the discussions, (4) the degree to which participants' opinions evolved as a result of the discussions, and (5) the quality of participant engagement. RESULTS: Most participants were thoughtful, reflective, and invested in this pilot policy-informing process. Throughout the pilot process, changes were made to background materials, the verbal introduction, and pre- and post-surveys. Importantly, by holding pilot meetings in two distinct communities (an affluent suburb and inner city neighborhood), we discerned that participants' ethical reflections were framed in large part by their place-based life experiences. CONCLUSION: This pilot process, coupled with extensive feedback from participants, yielded a refined methodology suitable for wider-scale use and underscored the need for involvement of diverse communities in a statewide engagement process on this critical policy issue.

Family understanding of seriously-ill patient preferences for family involvement in healthcare decision making.

BACKGROUND: Surrogate accuracy in predicting patient treatment preferences (i.e., what patients want) has been studied extensively, but it is not known whether surrogates can predict how patients want loved ones to make end-of-life decisions on their behalf. OBJECTIVE: To evaluate the ability of family members to correctly identify the preferences of seriously-ill patients regarding family involvement in decision making. DESIGN: Cross-sectional survey. PARTICIPANTS: Twenty-five pancreatic cancer and 27 amyotrophic lateral sclerosis (ALS) patients and their family members (52 dyads total). MAIN MEASURES: Patients and family members completed the Decision Control Preferences (DCP) scale regarding patient preferences for family involvement in health care decisions using conscious and unconscious scenarios. KEY RESULTS: Patient and family member agreement was 56% (29/52 dyads) for the conscious scenario (kappa 0.29) and 46% (24/52 dyads) for the unconscious scenario (kappa 0.15). Twenty-four family members identified the patient's preference as independent in the unconscious scenario, but six of these patients actually preferred shared decision making and six preferred reliant decision making. In the conscious scenario, preference for independent decision making was associated with higher odds of patient-family agreement (AOR 5.28, 1.07-26.06). In the unconscious scenario, cancer patients had a higher odds of agreement than ALS patients (AOR 3.86; 95% CI 1.02-14.54). CONCLUSION: Family members were often unable to correctly identify patient preferences for family involvement in end-of-life decision making, especially when patients desired that decisions be made using the best-interest standard. Clinicians and family members should consider explicitly eliciting patient preferences for family involvement in decision making. Additional research is still needed to identify interventions to improve family member understanding of patient preferences regarding the decision-making process itself.

Development and validation of the Family Decision-Making Self-Efficacy Scale.

OBJECTIVE: Several studies have reported high levels of distress in family members who have made health care decisions for loved ones at the end of life. A method is needed to assess the readiness of family members to take on this important role. Therefore, the purpose of this study was to develop and validate a scale to measure family member confidence in making decisions with (conscious patient scenario) and for (unconscious patient scenario) a terminally ill loved one. METHODS: On the basis of a survey of family members of patients with amyotrophic lateral sclerosis (ALS) enriched by in-depth interviews guided by Self-Efficacy Theory, we developed six themes within family decision making self-efficacy. We then created items reflecting these themes that were refined by a panel of end-of-life research experts. With 30 family members of patients in an outpatient ALS and a pancreatic cancer clinic, we tested the tool for internal consistency using Cronbach's alpha and for consistency from one administration to another using the test-retest reliability assessment in a subset of 10 family members. Items with item to total scale score correlations of less than .40 were eliminated. RESULTS: A 26-item scale with two 13-item scenarios resulted, measuring family self-efficacy in decision making for a conscious or unconscious patient with a Cronbach's alphas of .91 and .95, respectively. Test-retest reliability was r = .96, p = .002 in the conscious senario and r = .92, p = .009 in the unconscious scenario. SIGNIFICANCE OF RESULTS: The Family Decision-Making Self-Efficacy Scale is valid, reliable, and easily completed in the clinic setting. It may be used in research and clinical care to assess the confidence of family members in their ability to make decisions with or for a terminally ill loved one.

Family health care decision making and self-efficacy with patients with ALS at the end of life.

OBJECTIVE: Persons with ALS differ from those with other terminal illnesses in that they commonly retain capacity for decision making close to death. The role patients would opt to have their families play in decision making at the end of life may therefore be unique. This study compared the preferences of patients with ALS for involving family in health care decisions at the end of life with the actual involvement reported by the family after death. METHODS: A descriptive correlational design with 16 patient-family member dyads was used. Quantitative findings were enriched with in-depth interviews of a subset of five family members following the patient's death. RESULTS: Eighty-seven percent of patients had issued an advance directive. Patients who would opt to make health care decisions independently (i.e., according to the patient's preferences alone) were most likely to have their families report that decisions were made in the style that the patient preferred. Those who preferred shared decision making with family or decision making that relied upon the family were more likely to have their families report that decisions were made in a style that was more independent than preferred. When interviewed in depth, some family members described shared decision making although they had reported on the survey that the patient made independent decisions. SIGNIFICANCE OF RESULTS: The structure of advance directives may suggest to families that independent decision making is the ideal, causing them to avoid or underreport shared decision making. Fear of family recriminations may also cause family members to avoid or underreport shared decision making. Findings from this study might be used to guide clinicians in their discussions of treatments and health care decision making with persons with ALS and their families.

The search-inference framework: a proposed strategy for novice clinical problem solving.

CONTEXT: Medical education in the clinical clerkship years emphasises the systematic collection and organisation of patient information to be combined with domain-specific knowledge of disease processes. Eventually, novice clinical problem solvers will learn to recognise patterns within the patient data ('illness scripts') which suggest the main diagnostic possibilities. Before novice problem solvers develop these illness scripts, pattern recognition may not be effective for solving clinical problems. METHODS: This discussion paper describes the application of a decision framework adapted from cognitive psychology (the search-inference framework) to basic medical problem solving. Emphasis is placed on problem solving by novices who have not yet developed a full compliment of illness scripts. CONCLUSIONS: The search-inference framework is similar to the approach taken by laypersons to diagnose their own symptoms or solve other problems. It may be especially useful for students who have not yet developed a sizeable repertoire of illness scripts, and the principles described may also be invoked by experienced clinicians confronting difficult clinical problems.

How would terminally ill patients have others make decisions for them in the event of decisional incapacity? A longitudinal study.

OBJECTIVES: To determine the role terminally ill patients would opt to have their loved ones and physicians play in healthcare decisions should they lose decision-making capacity and how this changes over time. DESIGN: Serial interviews. SETTING: The study institutions were The Johns Hopkins Medical Institutions in Baltimore, Maryland, and St. Vincent's Hospital, in New York. PARTICIPANTS: One hundred forty-seven patients with cancer, amyotrophic lateral sclerosis, or heart failure, at baseline and 3 and 6 months. RESULTS: Patients' baseline decision control preferences varied widely, but most opted for shared decision-making, leaning slightly toward independence from their loved ones. This did not change significantly at 3 or 6 months. Fifty-seven percent opted for the same degree of decision control at 3 months as at baseline. In a generalized estimating equation model adjusted for time, more-independent decision-making was associated with college education (P=.046) and being female (P=.01), whereas more-reliant decision-making was associated with age (P<.001). Patients leaned toward more reliance upon physicians to make best-interest determinations at diagnosis but opted for physicians to decide based upon their own independent wishes (substituted judgment) over time, especially if college educated. CONCLUSION: Terminally ill patients vary in how much they wish their own preferences to control decisions made on their behalf, but most would opt for shared decision-making with loved ones and physicians. Control preferences are stable over time with respect to loved ones, but as they live longer with their illnesses, patients prefer somewhat less reliance upon physicians.

A clinician's guide to the diagnosis and treatment of interstitial lung diseases.

Interstitial lung disease (ILD) is a final common pathway for a large number of lung insults. It is characterized by progressive scarring of the lung leading to restriction and diminished oxygen transfer. Clinically, the presenting symptoms of ILD are nonspecific (cough and progressive dyspnea on exertion) and are often attributed to other diseases, thus delaying diagnosis and timely therapy. ILD occurs most commonly in older individuals and is increasingly encountered by internists. Both the diagnosis and treatment can be daunting: patients frequently have irreversibly impaired lung function at diagnosis, and therapeutic modalities are limited and associated with significant adverse effects. This review will assist internists in the recognition and management of ILD, provide a benchmark for pulmonary referrals, and offer guidance in advising patients with this life-threatening disorder.

Informed consent in clinical medicine.

Over the past third of a century, there has been a revolution in the way that health-care providers and patients make most medical decisions. Paternalism has slowly gone the way of the long-play record, and in its place has emerged a consent process in which the patient is a more fully informed and active participant. This process takes time however, and for the busy health-care provider there is often the temptation to hand the patient a consent form to sign. It is important to realize that signing a consent form does not constitute informed consent. True informed consent is a process, and, as such, it requires that the health-care provider enter into a discussion that ultimately leads to the patient understanding of their options, and the risks and benefits of the alternative courses of action. The purpose of this article was to describe, in some detail, the consent process in practical clinical terms, and to note when and how it should be obtained.

Failure to adopt beneficial therapies caused by bias in medical evidence evaluation.

BACKGROUND: Although it is known that many evidence-based therapies are underutilized, the causes of the research-practice gap are not well understood. The authors sought to determine if there is a bias in the evaluation of new evidence that leads to low rates of adoption of beneficial therapies compared to abandonment of harmful ones. METHODS: Two case vignettes describing hypothetical clinical trials were administered to 2 independent samples of pulmonary and critical care practitioners. Each vignette was presented in 2 different ways; in one version, the results of the hypothetical trial showed that a treatment was harmful, and in the other version, the same treatment was shown to be beneficial. Prospective respondents from each sample were randomized to receive 1 version of each vignette (intersubject design). The main outcome was respondent's willingness to apply the results of the hypothetical trial to patient care. RESULTS: There were 174 participants for trial 1 and 138 participants for trial 2 (enrollment rates of 44.2% and 41.8%, respectively). For trial 1, respondents were 2.3 times less likely to change clinical practice based on results indicating benefit as opposed to harm (33.3% v. 76.5%; P < 0.0001). Similarly, for trial 2, respondents were 2.57 times less likely to change practice when trial results showed that early use was beneficial as opposed to showing that early use was harmful (37.1% v. 95.3%; P < 0.0001). CONCLUSIONS: When evaluating clinical trials, physicians demonstrate less willingness to adopt beneficial therapies than to abandon harmful ones. This difference may contribute to the research-practice gap.

When patients lack capacity: the roles that patients with terminal diagnoses would choose for their physicians and loved ones in making medical decisions.

Current approaches to end-of-life decision making are widely considered inadequate. We explored these complexities by examining how patients with terminal diagnoses would choose to involve their physicians and loved ones in making medical decisions, assuming they were able and unable to participate. Cross-sectional interviews of 130 patients recently diagnosed with fatal conditions were conducted. Patients were recruited from two academic medical centers using a modification of the Decision Control Preferences Scale, ranging from independent decision making to decision making that relies upon others. Patients were asked how they would balance their own wishes relative to the input of physician and loved ones in making medical decisions, and to weigh the input of loved ones relative to physician. Most patients (52%), assuming they had the capacity, would opt to share decision making with their physicians, but 15% would defer to their physicians and 34% would make decisions independently. Similarly, 44% would share decision making with their loved ones, but fewer (6%) would defer to their loved ones. Thirty-nine percent would rely upon their physicians' judgments about what would be best for them rather than their own wishes if they became unconscious, compared with 15% who would do so if they were conscious (P < 0.001). Nonetheless, patients were more likely to weigh their loved ones' input more heavily than their physicians' input if they were unconscious (33%) than if they were conscious (7%, P = 0.05). Race, religion, gender, diagnosis, and health status were largely unassociated with patients' decision control preferences. Patients with terminal diagnoses report a wide diversity of decision control preferences, but most would opt to share decision making with their physicians and loved ones. If unable to decide for themselves, they shift toward greater reliance on physician input relative to their own wishes but would weigh loved ones' input more heavily than physician input. Deciding for patients who cannot speak for themselves may be more complex than has previously been reflected in law, policy, or clinical ethics.

Omission bias and decision making in pulmonary and critical care medicine.

BACKGROUND: Pulmonary and critical care physicians routinely make complex decisions, but little is known about cognitive aspects of this process. Omission bias and status quo bias are well-described cognitive biases that can cause lay decision makers to prefer inaction that preserves the status quo even when changing the status quo through action is more likely to lead to the best outcomes. It is unknown if these biases influence trained decision makers such as pulmonologists. STUDY OBJECTIVES: To determine whether omission bias and status quo bias influence the medical decisions of pulmonologists. DESIGN AND INTERVENTIONS: The study was a randomized controlled trial conducted within a cross-sectional survey of pulmonologists' opinions about the relevance of various factors in pulmonary and critical care decision making. We designed case vignettes that presented patient information with an associated patient management choice. The status quo state and the action/omission distinction were varied in two forms of otherwise identical vignettes. One form of each case vignette pair (A and B) was administered randomly to each prospective respondent during the first mailing of the opinion survey. PARTICIPANTS: Five hundred pulmonologists selected randomly from the membership of the American College of Chest Physicians. MEASUREMENTS AND RESULTS: There were 125 respondents, including 59 for form A and 66 form B (enrollment rate, 25%). In vignettes involving evaluation of pulmonary embolism and treatment of septic shock, respondents were more likely to choose a suboptimal management strategy when an omission option was present that allowed preservation of the status quo (71% vs 53%, p = 0.048; 50% vs 29%, p = 0.016, respectively). In a vignette involving a hypothetical clinical trial and the decision to prescribe tube feeding, the omission option was not significantly associated with the decision to prescribe tube feeding (54% vs 50%, p = 0.67). CONCLUSION: Pulmonary and critical care decisions are susceptible to the influence of omission and status quo bias. Because of the great number of decisions that are made each day involving choices between maintaining or changing the status quo, this finding could have far-reaching implications for patient outcomes, cost-effectiveness, resource utilization, clinical practice variability, and medical errors.