Seven Strategies to Integrate Equity within Translational Research in Neurology.

The rapidly accelerating translation of biomedical advances is leading to revolutionary therapies that are often inaccessible to historically marginalized populations. We identified and synthesized recent guidelines and statements to propose 7 strategies to integrate equity within translational research in neurology: (1) learn history; (2) learn about upstream forces; (3) diversify and liberate; (4) change narratives and adopt best communication practices; (5) study social drivers of health and lived experiences; (6) leverage health technologies; and (7) build, sustain, and lead culturally humble teams. We propose that equity should be a major goal of translational research, equally important as safety and efficacy. ANN NEUROL 2024;95:432-441.

Navigating Neurologic Illness: Skills in Neuropalliative Care for Persons Hospitalized with Neurologic Disease.

Persons hospitalized for neurologic illness face multidimensional care needs. They can benefit from a palliative care approach that focuses on quality of life for persons with serious illness. We describe neurology provider "skills" to help meet these palliative needs: assessing the patient as a whole; facilitating conversations with patients to connect prognosis to care preferences; navigating neurologic illness to prepare patients and care partners for the future; providing high-quality end-of-life care to promote peace in death; and addressing disparities in care delivery.

National Cost Estimates of Invasive Mechanical Ventilation and Tracheostomy in Acute Stroke, 2008-2017.

BACKGROUND: Patients with stroke receiving invasive mechanical ventilation (IMV) and tracheostomy incur intense treatment and long hospitalizations. We aimed to evaluate US hospitalization costs for patients with stroke requiring IMV, tracheostomy, or no ventilation. METHODS: We performed a retrospective observational study of US hospitalizations for acute ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage receiving IMV, tracheostomy, or none using the National Inpatient Sample, 2008 to 2017. We calculated hospitalization costs using cost-to-charge ratios adjusted to 2017 US dollars for inpatients with stroke by ventilation status (no IMV, IMV alone, tracheostomy). RESULTS: Of an estimated 5.2 million (95% CI, 5.1-5.3) acute stroke hospitalizations, 2008 to 2017; 9.4% received IMV alone and 1.4% received tracheostomy. Length of stay for patients without IMV was shorter (median, 4 days; interquartile range [IQR], 2-6) compared with IMV alone (median, 6 days; [IQR, 2-13]), and tracheostomy (median, 25 days; [IQR, 18-36]; P<0.001). Mortality for patients without IMV was 3.2% compared with 51.2% for IMV alone and 9.8% for tracheostomy (P<0.001). Median hospitalization costs for patients without IMV was $9503 (IQR, $6544-$14 963), compared with $23 774 (IQR, $10 900-$47 735) for IMV alone and $95 380 (IQR, $63 921-$144 019) for tracheostomy. Tracheostomy placement in ≤7 days had lower costs compared with placement in >7 days (median, $71 470 [IQR, $47 863-$108 250] versus $102 979 [IQR, $69 563-$152 543]; P<0.001). Each day awaiting tracheostomy was associated with a 2.9% cost increase (95% CI, 2.6%-3.1%). US hospitalization costs for patients with acute stroke were $8.7 billion/y (95% CI, $8.5-$8.9 billion). For IMV alone, costs were $1.8 billion/y (95% CI, $1.7-$1.9 billion) and for tracheostomy $824 million/y (95% CI, $789.7-$858.3 million). CONCLUSIONS: Patients with acute stroke who undergo tracheostomy account for 1.4% of stroke admissions and 9.5% of US stroke hospitalization costs. Future research should focus on the added value to society and patients of IMV and tracheostomy, in particular after 7 days for the latter procedure given the increased costs incurred and poor outcomes in stroke.

Association of Skilled Nursing Facility Participation in Voluntary Bundled Payments With Postacute Care Outcomes for Joint Replacement.

IMPORTANCE: The Medicare Bundled Payments for Care Improvement (BPCI) model 3 of 2013 holds participating skilled nursing facilities (SNFs) responsible for all episode costs. There is limited evidence regarding SNF-specific outcomes associated with BPCI. OBJECTIVE: To examine the association between SNF BPCI participation and patient outcomes and across-facility differences in these outcomes among Medicare beneficiaries undergoing lower extremity joint replacement (LEJR). DESIGN, SETTING, AND PARTICIPANTS: Observational difference-in-differences (DID) study of 2013-2017 for 330 unique persistent-participating SNFs, 146 unique dropout SNFs, and 14,028 unique eligible nonparticipating SNFs. MAIN OUTCOME MEASURES: Rehospitalization within 30 and 90 days after SNF admission, and rate of successful discharge from the SNF to the community. RESULTS: Total 636,355 SNF admissions after LEJR procedures were identified for 582,766 Medicare patients [mean (SD) age, 76.81 (9.26) y; 424,076 (72.77%) women]. The DID analysis showed that for persistent-enrollment SNFs, no BPCI-related changes were found in readmission and successful community discharge rates overall, but were found for their subgroups. Specifically, under BPCI, the 30-day readmission rate decreased by 2.19 percentage-points for White-serving SNFs in the persistent-participating group relative to those in the nonparticipating group, and by 1.75 percentage-points for non-Medicaid-dependent SNFs in the persistent-participating group relative to those in the nonparticipating group; and the rate of successful community discharge increased by 4.44 percentage-points for White-serving SNFs in the persistent-participating group relative to those in the nonparticipating group, whereas such relationship was not detected among non-White-serving SNFs, leading to increased between-facility differences (differential DID=-7.62). BPCI was not associated with readmission or successful community discharge rates for dropout SNFs, overall, or in subgroup analyses. CONCLUSIONS: Among Medicare patients receiving LEJR, BPCI was associated with improved outcomes for White-serving/non-Medicaid-dependent SNFs but not for other SNFs, which did not help reduce or could even worsen the between-facility differences.

Hospital Discharge and Readmissions Before and During the COVID-19 Pandemic for California Acute Stroke Inpatients.

BACKGROUND: Acute stroke therapy and rehabilitation declined during the COVID-19 pandemic. We characterized changes in acute stroke disposition and readmissions during the pandemic. METHODS: We used the California State Inpatient Database in this retrospective observational study of ischemic and hemorrhagic stroke. We compared discharge disposition across a pre-pandemic period (January 2019 to February 2020) to a pandemic period (March to December 2020) using cumulative incidence functions (CIF), and re-admission rates using chi-squared. RESULTS: There were 63,120 and 40,003 stroke hospitalizations in the pre-pandemic and pandemic periods, respectively. Pre-pandemic, the most common disposition was home [46%], followed by skilled nursing facility (SNF) [23%], and acute rehabilitation [13%]. During the pandemic, there were more home discharges [51%, subdistribution hazard ratio 1.17, 95% CI 1.15-1.19], decreased SNF discharges [17%, subdistribution hazard ratio 0.70, 95% CI 0.68-0.72], and acute rehabilitation discharges were unchanged [CIF, p<0.001]. Home discharges increased with increasing age, with an increase of 8.2% for those ≥85 years. SNF discharges decreased in a similar distribution by age. Thirty-day readmission rates were 12.7 per 100 hospitalizations pre-pandemic compared to 11.6 per 100 hospitalizations during the pandemic [p<0.001]. Home discharge readmission rates were unchanged between periods. Readmission rates for discharges to SNF (18.4 vs. 16.7 per 100 hospitalizations, p=0.003) and acute rehabilitation decreased (11.3 vs. 10.1 per 100 hospitalizations, p=0.034). CONCLUSIONS: During the pandemic a greater proportion of patients were discharged home, with no change in readmission rates. Research is needed to evaluate the impact on quality and financing of post-hospital stroke care.

Perioperative Neurological Evaluation and Management to Lower the Risk of Acute Stroke in Patients Undergoing Noncardiac, Nonneurological Surgery: A Scientific Statement From the American Heart Association/American Stroke Association.

Perioperative stroke is a potentially devastating complication in patients undergoing noncardiac, nonneurological surgery. This scientific statement summarizes established risk factors for perioperative stroke, preoperative and intraoperative strategies to mitigate the risk of stroke, suggestions for postoperative assessments, and treatment approaches for minimizing permanent neurological dysfunction in patients who experience a perioperative stroke. The first section focuses on preoperative optimization, including the role of preoperative carotid revascularization in patients with high-grade carotid stenosis and delaying surgery in patients with recent strokes. The second section reviews intraoperative strategies to reduce the risk of stroke, focusing on blood pressure control, perioperative goal-directed therapy, blood transfusion, and anesthetic technique. Finally, this statement presents strategies for the evaluation and treatment of patients with suspected postoperative strokes and, in particular, highlights the value of rapid recognition of strokes and the early use of intravenous thrombolysis and mechanical embolectomy in appropriate patients.

Skilled Nursing Facility Participation in a Voluntary Medicare Bundled Payment Program: Association With Facility Financial Performance.

IMPORTANCE: Model 3 of the Bundled Payments for Care Improvement (BPCI) is an alternative payment model in which an entity takes accountability for the episode costs. It is unclear how BPCI affected the overall skilled nursing facility (SNF) financial performance and the differences between facilities with differing racial/ethnic and socioeconomic status (SES) composition of the residents. OBJECTIVE: The objective of this study was to determine associations between BPCI participation and SNF finances and across-facility differences in SNF financial performance. DESIGN, SETTING, AND PARTICIPANTS: A longitudinal study spanning 2010-2017, based on difference-in-differences analyses for 575 persistent-participation SNFs, 496 dropout SNFs, and 13,630 eligible nonparticipating SNFs. MAIN OUTCOME MEASURES: Inflation-adjusted operating expenses, revenues, profit, and profit margin. RESULTS: BPCI was associated with reductions of $0.63 million in operating expenses and $0.57 million in operating revenues for the persistent-participation group but had no impact on the dropout group compared with nonparticipating SNFs. Among persistent-participation SNFs, the BPCI-related declines were $0.74 million in operating expenses and $0.52 million in operating revenues for majority-serving SNFs; and $1.33 and $0.82 million in operating expenses and revenues, respectively, for non-Medicaid-dependent SNFs. The between-facility SES gaps in operating expenses were reduced (differential difference-in-differences estimate=$1.09 million). Among dropout SNFs, BPCI showed mixed effects on across-facility SES and racial/ethnic differences in operating expenses and revenues. The BPCI program showed no effect on operating profit measures. CONCLUSIONS: BPCI led to reduced operating expenses and revenues for SNFs that participated and remained in the program but had no effect on operating profit indicators and mixed effects on SES and racial/ethnic differences across SNFs.

Predictors of Surrogate Decision Makers Selecting Life-Sustaining Therapy for Severe Acute Brain Injury Patients: An Analysis of US Population Survey Data.

BACKGROUND: Patients with a severe acute brain injury admitted to the intensive care unit often have a poor neurological prognosis. In these situations, a clinician is responsible for conducting a goals-of-care conversation with the patient's surrogate decision makers. The diversity in thought and background of surrogate decision makers can present challenges during these conversations. For this reason, our study aimed to identify predictive characteristics of US surrogate decision makers' favoring life-sustaining treatment (LST) over comfort measures only for patients with severe acute brain injury. METHODS: We analyzed data from a cross-sectional survey study that had recruited 1588 subjects from an online probability-based US population sample. Seven hundred and ninety-two subjects had randomly received a hypothetical scenario regarding a relative intubated with severe acute brain injury with a prognosis of severe disability but with the potential to regain some consciousness. Seven hundred and ninety-six subjects had been randomized to a similar scenario in which the relative was projected to remain vegetative. For each scenario, we conducted univariate analyses and binary logistic regressions to determine predictors of LST selection among available respondent characteristics. RESULTS: 15.0% of subjects selected LST for the severe disability scenario compared to 11.4% for the vegetative state scenario (p = 0.07), with those selecting LST in both groups expressing less decisional certainty. For the severe disability scenario, independent predictors of LST included having less than a high school education (adjusted OR = 2.87, 95% CI = 1.23-6.76), concern regarding prognostic accuracy (7.64, 3.61-16.15), and concern regarding the cost of care (4.07, 1.80-9.18). For the vegetative scenario, predictors included the youngest age group (30-44 years, 3.33, 1.02-10.86), male gender (3.26, 1.75-6.06), English as a second language (2.94, 1.09-7.89), Evangelical Protestant (3.72, 1.28-10.84) and Catholic (4.01, 1.72-9.36) affiliations, and low income (< $25 K). CONCLUSION: Several demographic and decisional characteristics of US surrogate decision makers predict LST selection for patients with severe brain injury with varying degrees of poor prognosis. Surrogates concerned about the cost of medical care may nevertheless be inclined to select LST, albeit with high levels of decisional uncertainty, for patients projected to have severe disabilities.

Proceedings from the Neurotherapeutics Symposium on Neurological Emergencies: Shaping the Future of Neurocritical Care.

Effective treatment options for patients with life-threatening neurological disorders are limited. To address this unmet need, high-impact translational research is essential for the advancement and development of novel therapeutic approaches in neurocritical care. "The Neurotherapeutics Symposium 2019-Neurological Emergencies" conference, held in Rochester, New York, in June 2019, was designed to accelerate translation of neurocritical care research via transdisciplinary team science and diversity enhancement. Diversity excellence in the neuroscience workforce brings innovative and creative perspectives, and team science broadens the scientific approach by incorporating views from multiple stakeholders. Both are essential components needed to address complex scientific questions. Under represented minorities and women were involved in the organization of the conference and accounted for 30-40% of speakers, moderators, and attendees. Participants represented a diverse group of stakeholders committed to translational research. Topics discussed at the conference included acute ischemic and hemorrhagic strokes, neurogenic respiratory dysregulation, seizures and status epilepticus, brain telemetry, neuroprognostication, disorders of consciousness, and multimodal monitoring. In these proceedings, we summarize the topics covered at the conference and suggest the groundwork for future high-yield research in neurologic emergencies.

Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute Therapies-Proposal of a Multidisciplinary Research Group.

INTRODUCTION: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs. METHODS: This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into "core", "supplemental-highly recommended", "supplemental" and "exploratory". RESULTS: We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs. CONCLUSION: Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.

Incidental Findings in Radiographic Imaging for Inpatients with Acute Ischemic Stroke.

BACKGROUND: Incidental findings on radiographic diagnostic imaging are a growing concern in the medical field. Little is known about the incidence and spectrum of incidental findings uncovered during stroke evaluations. METHODS AND RESULTS: A random sample of 200 acute ischemic stroke admissions at an academic medical center was reviewed to better understand the incidence and spectrum of incidental findings on radiographic imaging studies obtained for a stroke evaluation. Among 200 stroke patients, 53 (26.5%) were found to have one or more incidental findings on radiographic imaging. Over 651 imaging studies, 69 incidental findings were uncovered, or 11 incidental findings per 100 imaging studies. Incidental findings were most commonly discovered within computerized tomography angiograms of the head and neck (n = 41 from of 176 studies). The most commonly identified incidental findings included thyroid nodules (n = 12), sinus disease (n = 11), pulmonary nodules (n = 10), and intracranial/cervical artery aneurysms (n = 5). CONCLUSIONS: Incidental findings are commonly found in patients undergoing an evaluation for acute ischemic stroke, some of which may be clinically relevant. Vascular neurologists and other clinicians caring for stroke patients may benefit from guidance on the management of expected incidental findings.

Variability in Gastrostomy Tube Placement for Intracerebral Hemorrhage Patients at US Hospitals.

OBJECTIVE: We sought to characterize the variability among US hospitals with regard to gastrostomy tube placement for inpatients with intracerebral hemorrhage (ICH). METHODS: Using the Nationwide Inpatient Sample, we examined variations in the annual rate of gastrostomy tube placement from 2002 to 2011 for ICH patients admitted to hospitals with 30 or more annual ICH admissions. We then directly compared, among these hospitals, their individual frequencies of gastrostomy tube placement for ICH patients over the same time period. To quantify variability among hospitals, we used multilevel multivariable regression models accounting for a hospital random effect, adjusted for patient-level and hospital-level factors predictors of placement. RESULTS: Gastrostomy tube placement rates did not significantly change from 2002 to 2011 (9.8 to 8.7 per 100 admissions; P trend = .57). Among 690 hospitals with 38,080 ICH hospitalizations during this period, 10.4% of patients had a gastrostomy tube placed (n = 3976). Variation in the rate of placement among individual hospitals was large, from 0% to 34.4% (interquartile range 5.7%-13.6%). For a regression model controlling for patient and hospital covariates, the median odds ratio was 1.36 (95% confidence interval 1.28-1.44), indicating that if a patient moved from one hospital to another with a higher intrinsic propensity of placement, there was a 1.36-fold median increase in the odds of receiving a gastrostomy tube, independent of patient and hospital factors. CONCLUSIONS: Variation in gastrostomy tube placement rates across hospitals is large and may in part reflect differences in local practice patterns or patient and surrogate preferences.

For-Profit Hospital Status and Carotid Artery Stent Utilization in US Hospitals Performing Carotid Revascularization.

BACKGROUND AND PURPOSE: Carotid artery stenting may be an economically attractive procedure for hospitals and physicians. We sought to identify the association of hospital ownership (nonprofit versus for-profit) on carotid artery stenting (CAS) versus carotid endarterectomy utilization in US hospitals. METHODS: Using the Nationwide Inpatient Sample admissions for cerebrovascular disease from 2008 to 2011, we identified all private, nonfederal US hospitals performing at least 20 carotid revascularization procedures annually, including carotid artery stenting (International Classification of Diseases-Ninth Revision 00.63) or carotid endarterectomy (International Classification of Diseases-Ninth Revision 38.12). We used a multilevel multivariable logistic regression controlling for patient demographics, comorbidities, and hospital characteristics, to assess the effect of hospital ownership on CAS use. RESULTS: Across 723 hospitals (600 nonprofit, 123 for-profit), 66 731 carotid revascularization admissions were identified. Approximately 1 in 5 (n=11 641; 17.4%) revascularizations received CAS. The mean CAS rate among nonprofit hospitals was 17.5 per 100 revascularizations (median, 11.5; interquartile range, 5.2-24.5), and the mean CAS rate among for-profit hospitals was 24.2 per 100 revascularizations (median, 16.0; interquartile range, 6.7-33.3; P<0.001). Adjusting for patient and hospital characteristics, for-profit hospital designation was associated with greater odds of CAS (adjusted odds ratio, 1.45; 95% confidence interval, 1.07-1.98). CONCLUSIONS: For-profit hospital ownership is associated with a higher rate of CAS compared to nonprofit hospitals in those receiving carotid revascularization. Further research is needed to understand the individual- and system-level factors driving this difference.

Timing of Percutaneous Endoscopic Gastrostomy for Acute Ischemic Stroke: An Observational Study From the US Nationwide Inpatient Sample.

BACKGROUND AND PURPOSE: Stroke guidelines recommend time-limited trials of nasogastric feeding prior to percutaneous endoscopic gastrostomy (PEG) tube placement. We sought to describe timing of PEG placement and identify factors associated with early PEG for acute ischemic stroke. METHODS: We designed a retrospective observational study to examine time to PEG for ischemic stroke admissions in the Nationwide Inpatient Sample, 2001 to 2011. We defined early PEG placement as 1 to 7 days from admission. Using multivariable regression analysis, we identified the effects of patient and hospital characteristics on PEG timing. RESULTS: We identified 34 623 admissions receiving a PEG from 2001 to 2011, 53% of which received the PEG 1 to 7 days from admission. Among hospitals placing ≥10 PEG tubes, median time to PEG for individual hospitals ranged from 3 days to over 3 weeks (interquartile range 6-8.5 days). Older adult age groups were associated with early PEG (≥85 years versus 18-54 years: adjusted odds ratio 1.68, 95% confidence interval 1.50-1.87). Those receiving a PEG and tracheostomy were more likely to receive the PEG beyond 7 days, and these patients were more often younger compared with PEG only recipients. Those admitted to high-volume hospitals were more likely to receive their PEG early (≥350 versus <150 hospitalizations; adjusted odds ratio 1.26, 95% confidence interval 1.17-1.35). CONCLUSIONS: More than half of the PEG recipients received their surgical feeding tube within 7 days of admission. The oldest old, who may benefit most from time-limited trials of nasogastric feeding for ≥2 to 3 weeks, were most likely to receive a PEG within 7 days.

Are patients with amyotrophic lateral sclerosis at risk of a therapeutic misconception?

OBJECTIVES: To assess whether persons with amyotrophic lateral sclerosis (ALS) are at risk of a therapeutic misconception (TM) in which they misconceive research as treatment or overestimate the likelihood of its benefit. METHODS: 72 patients with ALS recruited via academic and patient organisations were surveyed using a hypothetical first-in-human intervention study scenario. We elicited their understanding of the purpose of the study ('purpose-of-research question') and then asked how they interpreted the question. We then asked for an estimate of the likelihood that their ALS would improve by participating and asked them to explain the meaning of their estimates. RESULTS: Although 10 of 72 (14%) subjects incorrectly said that the intervention study was 'mostly intending to help [me]' in response to the purpose-of-research question, 7 of those 10 thought that the question was asking them about their own motivations for participating. Overall, only one of 72 respondents (1.4%) both understood the purpose-of-research question as intended and gave the incorrect response. Subjects' mean estimate of likelihood of benefit was 31% (SD 26). This was due to 29 of 72 of respondents providing high estimates (50%-54% likelihood), which they said were expressions of hope and need for a positive attitude; among those who said their estimates meant 'those are the facts' or 'there is a lot of uncertainty', the estimates were much lower (12.6% and 18.5%, respectively). CONCLUSIONS: In this group of patients with ALS considering a hypothetical first-in-human intervention study, apparent TM responses have alternative explanations and the risk of true TM appears low.

Palliative Care Needs in the Neuro-ICU.

OBJECTIVES: Patients admitted to the neurological or neurosurgical ICU are likely to have palliative care needs. The goals of this project are to encourage the ICU team to identify palliative care needs for patients and their families and potential ways to meet those needs. DESIGN: Quality improvement project using a parallel-group prospective cohort design. SETTING: Single neuro-ICU at a large, academic medical center. PATIENTS: All patients admitted to the neuro-ICU from September 1, 2013, to November 30, 2013. INTERVENTIONS: We developed a palliative care needs screening tool consisting of four questions: 1) Does the patient have distressing physical or psychological symptoms? 2) Are there specific support needs for patient or family? 3) Are treatment options matched with patient-centered goals? 4) Are there disagreements among teams and family? We implemented this daily screening tool on morning rounds for one of two neurocritical care services that alternate admitting days to a single neuro-ICU. We examined prevalence and nature of palliative care needs and actions to address those needs, comparing the services with and without screening. MEASUREMENTS AND MAIN RESULTS: Over the 3-month period, 130 patients were admitted to the service with screening and 132 patients to the service without screening. The two groups did not differ with regard to age, gender, Glasgow Coma Scale, or diagnosis. Palliative care needs were identified in 62% of screened patients (80/130). Needs were mainly social support (53%) and establishing goals of care (28%). Screening was associated with more documented family conferences (p = 0.019) and a trend toward more palliative care consultations (p = 0.056). CONCLUSIONS: We developed a brief palliative care needs screening tool that identified palliative care needs for 62% neuro-ICU patients. This tool was associated with actions to meet these needs, potentially improving care for patients and their families.

"It is not guaranteed that you will benefit": True but misleading?

BACKGROUND: Participants of early-phase intervention trials for serious conditions provide high estimates of likelihood of benefit, even when informed consent forms do not promise such benefits. However, some technically correct, negatively stated benefits statements­such as "it is not guaranteed that you will benefit"­could play a role in raising expectations of benefit because in ordinary English usage such statements denote a likely but not a certain-to-occur event. METHODS: An experimental online survey of 584 English-speaking adults recruited online. They were randomized to receive one of two benefit statements ("not guaranteed" vs "some but very small chance"), using a hypothetical scenario of an early-phase clinical trial testing an intervention to treat amyotrophic lateral sclerosis. We assessed respondents' willingness to consider participating in the amyotrophic lateral sclerosis trial, their estimates of likelihood of benefit, and their explanations for those estimates. RESULTS: The two arms did not differ in willingness to consider participation in the amyotrophic lateral sclerosis trial. Those receiving "not guaranteed" benefit statement had higher estimates of benefit than those receiving "some but very small chance" statement (35.7% (standard deviation 20.2) vs 28.3% (standard deviation 22.0), p < 0.0001). A total of 43% of all respondents chose expressions of positive sentiment (hope and need to stay positive) as explanations of their estimates; these respondents' estimates of benefit were higher than others but similar between the two arms. The effect of benefit statements was greatest among those who chose "Those are just the facts" as the explanation for their estimate (31.0% (standard deviation 22.4%) in "not guaranteed" arm vs 18.9% (standard deviation 21.0%) in comparison arm, p = 0.008). CONCLUSION: The use of "not guaranteed" language in benefit statements, when compared to "small but very small chance" language, appeared to increase the perception of likelihood of benefit of entering an early-phase trial, especially among those who view their estimates of benefits as "facts." Such "no guarantee" benefit statements may be misleading and should not be used in informed consent forms.

Are therapeutic motivation and having one's own doctor as researcher sources of therapeutic misconception?

BACKGROUND: Desire for improvement in one's illness and having one's own doctor functioning as a researcher are thought to promote therapeutic misconception (TM), a phenomenon in which research subjects are said to conflate research with treatment. PURPOSE: To examine whether subjects' therapeutic motivation and own doctor functioning as researcher are associated with TM. METHODS: We interviewed 90 persons with advanced Parkinson's disease (PD) enrolled or intending to enrol in sham surgery controlled neurosurgical trials, using qualitative interviews. Subjects were compared by motivation (primarily therapeutic vs primarily altruistic or dually motivated by altruistic and therapeutic motivation), and by doctor status (own doctor as site investigator vs not) on the following: understanding of purpose of study; understanding of research procedures; perception of chance of direct benefit; and recollection and perceptions concerning the risks. RESULTS: 60% had primarily therapeutic motivation and 44% had their own doctor as the site investigator, but neither were generally associated with increased TM responses. Overall level of understanding of purpose and procedures of research were high. Subjects responded with generally high estimates of probability of direct benefit, but their rationales were personal and complex. The therapeutic-motivation group was more sensitive to risks. Five (5.6%) subjects provided incorrect answers to the question about purpose of research, and yet, showed excellent understanding of research procedures. CONCLUSIONS: In persons with PD involved in sham surgery clinical trials, being primarily motivated by desire for direct benefit to one's illness or having one's own doctor as the site investigator were not associated with greater TM responses.

Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units.

In the neuroscience intensive care unit (NICU), most patients lack the capacity to make their own preferences known. This fact leads to situations where surrogate decision makers must fill the role of the patient in terms of making preference-based treatment decisions, oftentimes in challenging situations where prognosis is uncertain. The neurointensivist has a large responsibility and role to play in this shared decision-making process. This review covers how NICU patient preferences are determined through existing advance care documentation or surrogate decision makers and how the optimum roles of the physician and surrogate decision maker are addressed. We outline the process of reaching a shared decision between family and care team and describe a practice for conducting optimum family meetings based on studies of ICU families in crisis. We review challenges in the decision-making process between surrogate decision makers and medical teams in neurocritical care settings, as well as methods to ameliorate conflicts. Ultimately, the goal of shared decision making is to increase knowledge amongst surrogates and care providers, decrease decisional conflict, promote realistic expectations and preference-centered treatment strategies, and lift the emotional burden on families of neurocritical care patients.