Social determinants of health: a need for better data capture in Asian American patients with hepatocellular cancer.

BACKGROUND: Social determinants of health lead to better cancer care. This multi-site, single-institution study sought to capture data on social determinants of health data in Asian Americans with hepatocellular carcinoma; this group constitutes 60% of patients with this malignancy and are often undertreated or not treated at all. METHODS: This study took advantage of an institutional initiative designed to capture and integrate social determinants of health data into the electronic medical record for all patients. Medical records of Asian Americans with hepatocellular cancer were reviewed to acquire data on housing instability, lack of transportation, financial concerns, and social isolation; a score of 1 indicated poor social determinants of health. RESULTS: Of 112 adult Asian American patients with hepatocellular cancer, 22 (20%) were Southeast Asian, and 74 (67%) described English proficiency/preference. Total noncompletion per domain (no question answered within that domain) was observed in 90 patients (80%) for housing instability; 90 (80%) for lack of transportation; 92 (82%) for financial hardship; and 90 (80%) for social isolation. A score of 1 (highest risk) was observed in 1 patient (0.9%) for housing instability; 1 (0.9%) lack of transportation; no patient for financial hardship; and 1 (0.9%) for social isolation. Of note, institution-wide benchmark total noncompletion rates were 0.3%, 0.3%, 47%, and 39% for these respective domains. CONCLUSION: High total noncompletion rates make social determinants of health data challenging to interpret and underscore the need for evidence-based guidelines on how best to capture such data in underserved patients.

Hiccups in patients with cancer: a multi-site, single-institution study of etiology, severity, complications, interventions, and outcomes.

BACKGROUND: To our knowledge, previous studies have not investigated hiccups in patients with cancer with detailed patient-level data with the goal of capturing a broad spectrum of hiccup symptomatology. METHODS: This multi-site, single institution study examined consecutive medical records to better understand hiccups in patients with cancer. RESULTS: A total of 320 patients are the focus of this report. The median age of patients when hiccups were first reported in the medical record was 63 years (range: 21, 97 years) with 284 (89%) men and 36 (11%) women. The most common diagnose was gastrointestinal cancer. Hiccups most frequently occurred daily, as seen in 194 patients (62%), and the most common duration was less than 1 week, as seen in 146 patients (47%). However, nine patients had had daily hiccups for greater than 6 weeks, and 5 had symptoms for years. Cited etiology was non-chemotherapy medications in 36 (11%) and cancer chemotherapy in 19 (6%). Complications occurred in approximately a third and included insomnia in 51 patients (16%); hospitalization or emergency department visit in 34 (11%); and musculoskeletal pain in 23 (7%). Baclofen was the single most prescribed agent for hiccup palliation, but 100 patients received more than one medication. Medical procedures, which included acupuncture, paracentesis, or phrenic nerve block, were performed in 5 patients. In 234 patients (73%), the medical record documented hiccup cessation. CONCLUSIONS: Hiccups appear to be highly problematic in a small subset of patients with cancer with no well-defined palliative approaches.

Intensive Care Unit and Hospital Outcomes of Patients Admitted with Blastomycosis: A 14-Year Retrospective Study.

INTRODUCTION: Blastomycosis is an uncommon; potentially life-threatening granulomatous fungal infection. The aim of this study is to report hospital and intensive care unit (ICU) outcomes of patients admitted with blastomycosis. METHODS: All patients admitted for treatment of blastomycosis at the Mayo Clinic-Rochester, Minnesota between 01/01/2006 and 09/30/2019 were included. Demographics, comorbidities, clinical presentation, ICU admission, and outcomes were reviewed. RESULTS: A total of 84 Patients were identified with 90 unique hospitalizations primarily for blastomycosis. The median age at diagnosis was 49 (IQR 28.1-65, range: 6-85) years and 56 (66.7%) were male. The most frequent comorbidities included hypertension (n = 28, 33.3%); immunosuppressed state (n = 25, 29.8%), and diabetes mellitus (n = 21, 25%). The lungs were the only organ involved in 56 (66.7%) cases and the infection was disseminated in 19 (22.6%) cases. A total of 29 patients (34.5%) underwent ICU admission due to complications of blastomycosis. ICU related events included mechanical ventilation (n = 20, 23.8%), acute respiratory distress syndrome (ARDS) (n = 13, 15.5%), tracheostomy (n = 9, 10.7%), renal replacement therapy (n = 8, 9.5%), and extracorporeal membrane oxygenation (ECMO) (n = 4, 4.8%). A total of 12 patients (14.3%) died in the hospital; all of whom had undergone ICU admission. In-hospital mortality was associated with renal replacement therapy (RRT) (P = 0.0255). CONCLUSION: Blastomycosis is a serious, potentially life-threatening infection that results in significant morbidity and mortality with a 34.5% ICU admission rate. RRT was associated with in-hospital mortality.

ICU and Hospital Outcomes in Patients with Hepatopulmonary Syndrome Undergoing Liver Transplantation.

PURPOSE: There are limited data regarding hospital and intensive care unit (ICU) outcomes in patients with hepatopulmonary syndrome (HPS) following liver transplantation (LT). METHODS: Data were retrospectively collected from consecutive HPS adult patients who underwent LT and were immediately admitted to the ICU at three transplant centers with shared management protocols, from 2002 to 2018. Demographic, clinical, surgical, laboratory, and outcome data were extracted. RESULTS: We identified 137 patients (74 male, 54%), with a median age at LT of 58 years (IQR: 52-63). One hundred and 31 (95.6%) patients were admitted to the ICU on invasive mechanical ventilation (MV). The median time on invasive MV in the ICU was 12 hours (IQR: 5-28) and 97 patients (74%) were extubated within 24 hours of ICU admission. The median highest positive end expiratory pressure and fraction of inspired oxygen (FiO2) were 7 (IQR: 5-8) and 0.6 (IQR: 0.5-0.7), respectively. 7 patients (5%) developed severe post-transplant hypoxemia. Of all patients, 42 (30.4%) required vasopressors and the median ICU and hospital length of stay (LOS) were 3 (IQR: 1-5) and 10 (IQR: 7-20) days, respectively. The in-hospital mortality rate was 3.6% (5/137). HPS severity was not associated with hospital mortality. CONCLUSION: Most HPS patients have short durations of MV, ICU, and hospital LOS post-LT. HPS severity does not impact hospital mortality.

Population-based incidence of food allergies in Olmsted County over 17 years.

Background: There is growing concern about the rising incidence and prevalence of food allergy globally. We previously reported the incidence of food allergy in Olmsted County, Minnesota, between 2002 and 2011. We sought to update the incidence and temporal trends of food allergies in our region through 2018. Methods: By using the Rochester Epidemiology Project, all Olmsted County residents, with an incident diagnosis of food allergy between January 2, 2012, and December 31, 2018, were identified and their medical records were reviewed. These cases were combined with the previously collected incidence cases from January 2, 2002, and December 31, 2011, to understand longitudinal trends in food allergy incidence rates. Results: Over the 17-year study period, 1076 patients (58.0% male patients, 72.1% white) were diagnosed with an incident food allergy. The median (interquartile range) age at first diagnosis was 2.0 years (1.1-8.4 years). The overall annual incidence rate for all ages was 3.9 (95% confidence interval [CI], 3.6-4.1) per 10,000 person-years and was significantly higher in male than in female patients (4.4 [95% CI, 4.0-4.7] and 3.3 [95% CI, 3.0-3.6], respectively; p < 0.001). The most common food allergen was egg in infancy (57.7%), peanuts in ages 1-4 years (58.3%), tree nuts in ages 5-18 years (57.4%), and seafood in adults (≥19 years) (45.3%). Conclusion: The incidence of food allergy in Olmsted County steadily increased from 2002 to 2008, then remained relatively stable between the years 2008 and 2013, and again presented a rising trend over the next 5 years until 2018. This warrants further investigations into the effects of changes in guidelines for early introductions of allergenic foods and other factors that affect causality.

Observations with alpelisib in older patients (≥ 65 year of age) with breast cancer in a non-clinical trial setting.

PURPOSE: Alpelisib is newly-available breast cancer agent that targets PIK3 mutations and confers a somewhat unusual adverse event profile. This study focused on older patients (≥ 65 years of age) treated outside a clinical trial to gain further experience on how these under-studied patients do with this new agent. METHODS: This descriptive, multi-site study relied on medical record review. RESULTS: Fifty-one older breast cancer patients were started on alpelisib between May 2019 and September 2020. The median age and number of comorbidities at alpelisib initiation was 71 years and 4, respectively. Thirty-five patients had stopped alpelisib (median time on drug 2.6 months (range: < 1, 9.5 months)) for the following reasons: alpelisib adverse events (n = 15), cancer progression (n = 13), and other/unknown (n = 7). Alpelisib adverse events included hyperglycemia (n = 37), diarrhea (n = 23), rash (n = 19), fatigue (n = 12), and mouth sores (n = 7); (numbers in parentheses indicate the number of patients with at least one such event). Five patients were hospitalized for hyperglycemia. At the time of report, 14 patients were deceased, and median survival had not been reached. CONCLUSION: Older patients might derive further benefit from alpelisib if the adverse event profile of this agent, particularly the hyperglycemia, were able to be better managed.

An international, multicenter study of intravenous bevacizumab for bleeding in hereditary hemorrhagic telangiectasia: the InHIBIT-Bleed study.

Hereditary hemorrhagic telangiectasia (HHT, Osler-Weber-Rendu disease) is a rare multisystem vascular disorder causing chronic gastrointestinal bleeding, epistaxis, and severe anemia. Bevacizumab, an anti-vascular endothelial growth factor antibody, may be effective to treat bleeding in HHT. This international, multicenter, retrospective study evaluated the use of systemic bevacizumab to treat HHT-associated bleeding and anemia at 12 HHT treatment centers. Hemoglobin, epistaxis severity score, red cell units transfused, and intravenous iron infusions before and after treatment were evaluated using paired means testing and mixed-effects linear models. 238 HHT patients received bevacizumab for a median of 12 (range, 1-96) months. Compared with pretreatment, bevacizumab increased mean hemoglobin by 3.2 g/dL (95% CI, 2.9-3.5 g/dL) [mean hemoglobin 8.6 (8.5, 8.8) g/dL versus 11.8 (11.5, 12.1) g/dL, p<0.0001)] and decreased the epistaxis severity score (ESS) by 3.4 (3.2-3.7) points [mean ESS 6.8 (6.6-7.1) versus 3.4 (3.2-3.7), P<0.0001] during the first year of treatment. Compared with 6 months pretreatment, RBC units transfused decreased by 82% [median of 6.0 (IQR 0.0-13.0) units versus 0 (IQR, 0.0-1.0) units, P<0.0001] and iron infusions decreased by 70% [median of 6.0 (1.0-18.0) infusions versus 1.0 (0.0-4.0) infusions, P<0.0001] during the first 6 months of bevacizumab treatment. Outcomes were similar regardless of underlying pathogenic mutation. Following initial induction infusions, continuous/scheduled bevacizumab maintenance achieved higher hemoglobin and lower ESS than intermittent/as needed maintenance but with more drug exposure. Bevacizumab was well tolerated: hypertension, fatigue, and proteinuria were the most common adverse events. Venous thromboembolism occurred in 2% of patients. In conclusion, systemic bevacizumab was safe and effective to manage chronic bleeding and anemia in HHT.

Rare Adverse Events with Programmed Death-1 and Programmed Death-1 Ligand Inhibitors: Justification and Rationale for a Systematic Review.

PURPOSE: Immune checkpoint inhibitors are a new class of cancer drug that spawn unusual adverse events that generate unusual and sometimes unexpected adverse events. Despite databases that track such adverse events, there remains a need to also generate systematic reviews to capture side effects from such agents. FINDINGS: We generated a systematic compendium of adverse event reports. Extensively reviewing the published literature of case reports and case series, we relied on the peer process to compile a resource for clinicians of rare adverse events associated with checkpoint inhibitors. We used this compendium as a platform to provide broad-based comments on the role of systematic reviews in gathering such adverse event data. This approach generated 265 types of rare adverse events that had been reported, the most frequent of which were autoimmune type I diabetes (n = 62), pneumonitis (n = 40), myocarditis (n = 39), and colitis (n = 36). More unusual adverse events were also catalogued. Some adverse events that initially seemed unusual turned out to be more frequently reported over time and thus lost their novelty-an important point which provides context for how adverse events should be viewed when new drugs become available. Additionally, in contrast to such resources as the FDA Adverse Event Reporting System (FAERS), this systematic review relied on peer-reviewed data-another important point which adds strength to such systematic reviews. This report provides a compendium of rare and usual adverse events, serves as a resource to cancer clinicians, and appears to be justified based on the reported findings.

Newer Biological Agents in the Treatment of Severe Asthma: Real-World Results from a Tertiary Referral Center.

PURPOSE: To determine the efficacy of IL-5 inhibitory therapy in severe, refractory asthma in a real-world clinical setting from a tertiary referral center. METHODS: A retrospective chart review of patients with severe asthma treated with IL-5 biologic therapy for ≥ 6 months at Mayo Clinic in Rochester, Minnesota between January 1, 2013 and August 31, 2019. RESULTS: Over the study period, we identified 63 patients with a mean age of 54 who received an IL-5 inhibitor for ≥ 6 months. A total of 55 patients received mepolizumab, 2 received benralizumab, and 9 patients received both. Patients were followed up for a mean of 25 months. The mean number of months of oral prednisone use prior to biologic initiation was 64. There was a significant reduction in the median dose of prednisone in the 24 months after drug initiation (15 mg vs. 0 mg; p = < 0.0001). Similarly; there was a significant decline in the median number of asthma exacerbations in the 24 months before and after drug initiation (7 vs. 2; p = < 0.0001). The mean number of emergency room (ER) visits and hospitalizations decreased from 5.1 and 2.0 to 1.6 and 0.4 in the 24 months before and after therapy initiation (p < 0.0001 and p = 0.007, respectively) CONCLUSIONS: IL-5 inhibitory therapy is associated with significant and long-term sustained reductions in asthma exacerbation frequency, ER visits, hospitalizations, as well as oral steroid usage in a patient population with refractory steroid-dependent asthma referred to a tertiary referral center.

Pulmonary Arteriovenous Malformations in Non-hereditary Hemorrhagic Telangiectasia Patients: An 18-Year Retrospective Study.

PURPOSE: Pulmonary arteriovenous malformations (PAVMs) are most commonly associated with hereditary hemorrhagic telangiectasia (HHT). Patients with PAVMs can present with serious complications including stroke, transient ischemic attack (TIA), and brain abscess. PAVMs are rare in non-HHT patients and little is known about this patient population. The aim of this retrospective study is to better understand clinical presentation and outcomes of PAVMs occurring exclusively in non-HHT patients. METHODS: Non-HHT patients with PAVMs at the Mayo Clinic-Rochester between 01/01/2000 and 12/31/2018 were reviewed. Patients with Curacao score > 1 were excluded. Demographics, imaging characteristics, neurological complications, and follow-up imaging were analyzed. RESULTS: Seventy-seven patients with PAVMs were identified. The mean age at diagnosis was 48.2 ± 18.3 years with female preponderance (59.7%). The majority of PAVMs had lower lobe predominance (66.7%) and were simple and single in 75.3% and 89.6% of cases, respectively. Most patients were asymptomatic (46.8%) with dyspnea being the most common symptom (28.6%). Neurologic complications occurred in 19.5% of patients. The majority of PAVMs were idiopathic (61%). Thirty patients (39%) had one or more possible risk factors including previous thoracic surgery (23.4%), congenital heart disease (19.5%), and chest trauma (10.4%). Embolization was performed in 37 (48.1%) patients and only 4 (5.2%) underwent surgical resection. CONCLUSIONS: Non-HHT PAVMs occur more commonly in females, are most commonly simple and single, and have lower lobe predominance and a high rate of neurologic complications. Potential predisposing risk factors were identified in about 40% of the cases. Clinicians should be aware of the risk of PAVM development in patients with history of chest trauma, congenital heart disease, lung infection/abscess, and thoracic surgery.

Social Determinants of Health: A Need for Evidence-Based Guidelines on How to Capture Data on Underserved Patients.

Background . Social determinants of health lead to better cancer care. This multi-site, single-institution study sought to capture data on social determinants of health data in Asian Americans with hepatocellular carcinoma; this group constitutes 60% of patients with this malignancy and are often undertreated or not treated at all. Methods . This study took advantage of an institutional initiative designed to capture and integrate social determinants of health data into the electronic medical record for all patients. Medical records of Asian Americans with hepatocellular cancer were reviewed to acquire data on housing instability, lack of transportation, financial concerns, and social isolation; a score of 1 indicated poor social determinants of health. Results . Of 112 adult Asian American patients with hepatocellular cancer, 22 (20%) were Southeast Asian, and 74 (67%) described English proficiency. A score of 1 (highest risk) was observed in 1 patient (0.9%) for housing instability; 1 (0.9%) lack of transportation; no patient for financial hardship; and 1 (0.9%) for social isolation. However â€" and importantly -- total noncompletion per domain (no question answered within that domain) was observed in 90 patients (80%) for housing instability; 90 (80%) for lack of transportation; 92 (82%) for financial hardship; and 90 (80%) for social isolation. Of note, institution-wide benchmark total noncompletion rates were 0.3%, 0.3%, 47%, and 39% for these respective domains. Conclusion . High total noncompletion rates make social determinants of health data challenging to interpret and underscore the need for evidence-based guidelines on how best to capture such data in underserved patients.

Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study.

Rural patients are often underrepresented in cancer clinical trials. This is a secondary analysis of a study that tested short (2000 word) versus long (6000 word) consent forms with a focus on rurality. Among 240 patients, 89 (37%) were rural. Seventy-one (80%) rural and 117 (77%) nonrural patients signed a consent form of any length (P = .68). Forty-one of 47 (87%) rural patients signed a short consent form; in contrast, 30 of 42 (71%) signed a long form. These trends suggest rural patients are more likely to sign short consent forms. Further study is indicated.

Understanding "Patient refuses" among 90+ year old patients with cancer or presumed cancer.

OBJECTIVES: Patients who are 90+ years of age are a growing - but understudied - group at risk for cancer. Because many of these patients are undertreated (with no tissue/cytologic diagnosis), we sought to better understand how such decisions are arrived upon. METHODS: This study focused on patients between 2007 and 2017. None had received cancer therapy. Medical records were reviewed for quotations relevant to decision-making and analyzed qualitatively. RESULTS: Ninety-four patients (median age 93 years) with a cancer diagnosis/presumed diagnosis were identified; most were women (82%) with an average of six co-morbidities (dementia occurred in approximately one-third). The primary qualitative theme was a keen appreciation on the part of all stakeholders of the gravity of the decision to forgo a cancer work-up/therapy, with four subthemes: 1) substantial, detailed medical information about the patient's medical condition ("600 mL of yellow, hazy fluid with an LDH [lactate dehydrogenase] level greater than 450 …"); 2) complex discussions about the risks and benefits of no biopsy and/or no cancer treatment ("[the patient] would not prefer to have the quality of any remaining time ruined with salvage chemo and radiation"); 3) the inclusion of multiple individuals in decision-making ("I had a lengthy discussion with the patient and her daughter;" "I spoke by phone with one of my pathology colleagues"); and 4) patient-voiced decision-making ("I want to die."). CONCLUSION: Healthcare providers appear to understand the seriousness of no cancer-directed therapy and no work-up in patients 90 years of age and older. Neither ageism nor nihilism was observed.

Alpelisib-induced hyperglycemia in older patients with breast Cancer: Qualitative findings.

BACKGROUND: The PIK3 kinase inhibitor, alpelisib, is a new breast cancer drug that can cause hyperglycemia, which can be especially severe in older patients. Yet, to our knowledge, no prior studies have sought to understand what older patients experience with alpelisib-induced hyperglycemia. METHODS: The medical records of patients who were 65 years of age or older at the initiation of alpelisib and who developed hyperglycemia were reviewed in detail; direct verbiage on hyperglycemia were extracted and reviewed with rigorous qualitative methods. RESULTS: Thirty-four women with a median age of 72 (range: 65, 85) are the subject of this report; twelve had been started on insulin, four had been hospitalized for hyperglycemia, and eleven appeared to stop alpelisib because of hyperglycemia. Qualitative analyses revealed two themes. The first was patient burden, which emanated from patients' having to self-monitor glucose levels ("Monitors blood glucose (BG) 4 times daily"); taking extra medications ("Taking Jardiance 10 mg daily and Pioglitazone 15 mg daily"); frequent changes in insulin dosing ("Her insulin… was then increased…."); and frequent changes in dosing of alpelisib to help control the hyperglycemia ("Instructed to hold Piqray …."), and which also emanated from greater engagement with the healthcare system ("She was hospitalized for hyperglycemia"). The second theme focused on symptomatology and how patients suffered from hyperglycemia ("She presents to the emergency department with pre-syncope and vertigo"). CONCLUSION: Oncologists should assess older patients for the requisite abilities and resources for managing alpelisib-induced hyperglycemia in the event it occurs.

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients.

ABSTRACT: Ketogenic diets appear promising for obesity, diabetes, cancer, and other illnesses. Because older patients are more likely to contend with such illnesses and because of a paucity of dietary outcomes among these patients, we examined ketogenic diets in older patients.This multisite study focused on patients (≥65 years of age) on a ketogenic diet. Medical records were identified with the keywords "keto," "ketogenic," and "Atkins." Records were reviewed in detail with extraction of direct quotations to substantiate observations.We report on 200 consecutive patients with a median age of 70 years. Reasons for diet included weight loss, diabetes, and cancer; the majority remained on the diet for >1 month. In 134 (67%: 95% confidence interval: 60, 73%), the ketogenic diet appeared beneficial: 93 of 117 (79%) who sought weight loss lost weight ("She has lost 15 pounds and plans to lose another 8"); 36 of 67 (54%) who sought glucose control appeared to achieve the latter ("He has gone on a ketogenic diet and has been able to bring his sugars down significantly"); and 5 of 8 (63%) who sought improved cancer outcomes appeared to derive them ("He attributes part of the control of his cancer and increased QOL to adopting the keto for cancer diet"). Adverse events occurred in 30 patients (15%): dyslipidemia (n = 14), constipation (n = 9), sub-therapeutic international normalized ratio (n = 3), pancreatitis (n = 2), diarrhea (n = 1), and fatigue (n = 1).Trials that test ketogenic diets for a variety of illnesses should enroll older adults.

Non-Squamous, Non-Basal Cell Cancers of the Skin: Exploring Associations Between Site of Disease and Depression.

BACKGROUND: Earlier studies report a direct association between diseases of the skin-particularly those on the face-and depression. However, to our knowledge, such associations have not been examined in patients with non-squamous, non-basal call skin cancers. METHODS: The primary goal was to assess whether malignant skin disease-specifically on the face as opposed to other sites-was associated with depression. The medical records of patients with cutaneous cancer (either primary or metastatic but non-squamous, non-basal cell) were reviewed for the relevant data. RESULTS: One hundred and sixty-five patients were studied. Only 23 patients (14%) had metastases to the face, and 115 (70%) had a readily viewable skin cancer. Twenty-one patients (13%) developed depression after a diagnosis of cutaneous cancer (of note, the rate of missing data for depression was 37%). Only one patient with facial cutaneous cancer manifested depression, yielding an odds ratio for not developing depression (95% confidence interval (CI)) of 4.4 (0.5,35); p = 0.13. Depression appeared to occur more often in women (62% versus 43%), patients with a history of depression (52% versus 6%), and younger patients (median age with and without depression 55 years and 67 years, respectively). CONCLUSION: In contrast to other cutaneous diseases, no association was found between cutaneous cancer to the face and depression. Nonetheless, high rates of missing data underscore the need to focus on depression in patients with cutaneous cancers in the future.

Metastatic or suspected metastatic cancer in patients 90 years of age or older: A single-institution, multi-site study.

BACKGROUND: Metastatic cancer in nonagenarians and those older is rare and understudied. Here we explored whether these patients appear to benefit from antineoplastic therapy and whether outcomes differ based on whether or not untreated patients had a histologic/cytologic confirmation of cancer. METHODS: In this single-institution, multi-site study, we reviewed 10 years of consecutive medical records of patients 90+ years of age with a histologic/cytologic cancer diagnosis and metastatic cancer or, alternatively, a presumed metastatic cancer diagnosis. RESULTS: Sixty-eight patients are the focus with a median age of 93 years (range: 90, 103 years). Patients fell into 3 groups: 1) no tissue/cytologic cancer diagnosis and no treatment (=23); 2) tissue/cytologic diagnosis but no treatment (n = 21); and 3) cancer treatment rendered (n = 24). The median survival in groups 1,2, and 3 was 5 weeks (95% confidence interval (CI): 2, 11 weeks), 9 weeks (95% CI: 3, 23 weeks), and 60 weeks (95% CI: 38 weeks, not yet reached), respectively. For those patients in group 3 who received cancer therapy, chemotherapy, radiation, and surgery were administered in 11 (16%), 6 (9%), and 4 (6%), respectively. Fourteen received other cancer therapy: hormonal therapy (n = 6), targeted therapy (n = 6), and immunotherapy (n = 2). Only one patient experienced an adverse event that required hospitalization. CONCLUSIONS: Although these older patients likely received cancer treatment on a selective basis, such treatment was associated with improved survival and was well-tolerated. However, based on survival outcomes, one might question whether to put patients through a biopsy, if they have limited therapeutic options.

Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.

PURPOSE: This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients' decision making on trial enrollment. METHODS: This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making. RESULTS: In phase II, 93 patients were accrued and prompted the selection of the 2,000-word consent form for phase III. In phase III, 182 patients were recruited, resulting in 240 total evaluable patients to compare the 2,000-word versus the 6,000-word arm (control). For the primary end point, 103 (84%) and 107 (91%) patients in the 2,000- and 6,000-word arms, respectively, strongly agreed or agreed with the following: "The information in this consent form helped me make a decision about whether or not to enroll in the trial" (two-sided, P = .14). Median time to read each consent form was 8 and 12 minutes, respectively (two-sided, P < .0001). Among those assigned these consent forms, 84% and 73%, respectively (two-sided, P = .04) signed or expressed a willingness to sign. CONCLUSION: This study's primary end point was not met. However, secondary outcomes suggest a need to further study the efficiency and efficacy of shorter consent forms for cancer clinical trial enrollment.