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Introduction: Gout is a common comorbidity among solid organ transplantation patients and is usually attributed to the use of cyclosporine. This study aims to evaluate the prevalence of gout among solid organ transplantation patients to determine the prevalence in the tacrolimus era. Research Questions: To what degree is cyclosporine still used among prevalent solid organ transplantation patients? How prevalent is gout in the solid organ transplantation population not being treated by cyclosporine? Methods: Immunosuppressant regimens and gout prevalence among prevalent solid organ transplantation patients were assessed using retrospective claims data for a representative sample of commercially insured patients. For comparison to the prevalent solid organ transplantation population, immunosuppressant use at time of transplantation was compiled from published reports. Results: Between 2012 and 2016, the use of cyclosporine declined while use of tacrolimus increased, with greater cyclosporine use among prevalent versus incident solid organ transplantation patients. The prevalence of gout was 18.3%, 9.3%, and 9.1% for solid organ transplantation patients on cyclosporine, tacrolimus, and neither, respectively. Among all solid organ transplantation patients with gout, 66.6% and 21.5% were on tacrolimus versus cyclosporine. The prevalence of gout among noncyclosporine solid organ transplantation patients was significantly higher than in the general population without solid organ transplantation. Discussion: Despite declining cyclosporine use, gout prevalence remains high, with the majority of patients with gout receiving tacrolimus rather than cyclosporine. In summary, gout remains a frequent comorbidity of solid organ transplantation.

Background Spine care is costly and subject to wide variability. Defining costs and patterns of care for different specialties is critical to improving value. Objective Determine costs, utilization, and differences therein for nonoperative and operative specialists in treating low back disorders. We hypothesized costs associated with nonoperative specialists would be lower. Design Retrospective cohort. Setting Medicare Limited Data Set (5% sample), 2011 to 2014. Participants A total of 170 011 patients saw a primary care provider for a low back disorder between 1 July 2011, and 1 January 2013. Excluding those seen for a low back disorder in the preceding 6 months, final cohorts totaled 11 829 patients subsequently evaluated by a physiatrist (specialist in physical medicine and rehabilitation; 3183 patients) or surgeon (orthopedic or neurosurgeon; 8646 patients) within the following 6 months. Main outcome measures Total Medicare expenditures, spine-specific costs, spine surgical rates over 24 months. Results Cohorts had comparable demographics, initial diagnoses, and baseline mean per-member per-month (PMPM) total spending. Mean 2-year spine-specific spending was $3978 for the physiatrist cohort and $7387 for the surgeon cohort. Comparatively, the physiatrist cohort had lower total mean 2-year spine-specific spending (-$3409; 95% confidence interval [CI] -$3824 to -$2994), mean PMPM total spending (-$122/mo; CI -$184 to -$60), and surgical rate (7.8% vs. 18.9%, risk ratio [RR] = 0.41; CI 0.36-0.47). Surgery predominantly drove cost differential. Mean PMPM total spending for both cohorts remained elevated at 24 months compared to baseline mean spending (physiatrist: +$293; CI $447 to $138; surgeon: +$325; CI $425 to $225). Conclusions Following a new episode of a low back disorder, substantial costs were seen for those subsequently evaluated by a physiatrist or surgeon. Costs were considerably lower for those first seen by a physiatrist. Patients in both cohorts displayed long-term increases in health care costs. Our data suggest that early engagement in nonoperative care, when appropriate, may improve value.

Background The causal relationship between gout and renal transplant outcomes is difficult to assess due to multiple interacting covariates. This study sought to estimate the independent effect of new-onset gout on renal transplant outcomes using a methodology that accounted for these interactions. Methods This study analyzed data on patients in the US Renal Data System (USRDS) who received a primary kidney transplant between 2008 and 2015. The exposure was new-onset gout, and the primary endpoint was returning to dialysis >12 months postindex date (transplant date). A marginal structural model (MSM) was fitted to determine the relative risk of new-onset gout on return to dialysis. Results 18 525 kidney transplant recipients in the USRDS met study eligibility. One thousand three hundred ninety-nine (7.6%) patients developed new-onset gout, and 1420 (7.7%) returned to dialysis >12 months postindex. Adjusting for baseline and time-varying confounders via the MSM showed new-onset gout was associated with a 51% increased risk of return to (RR, 1.51; 95% CI, 1.03-2.20). Conclusions This finding suggests that new onset gout after kidney transplantation could be a harbinger for poor renal outcomes, and to our knowledge is the first study of kidney transplant outcomes using a technique that accounted for the dynamic relationship between renal dysfunction and gout.

Prader-Willi syndrome (PWS) is a complex developmental genetic disorder associated with hypotonia, poor feeding in neonates, onset of hyperphagia in early childhood, and shorter overall life expectancy. Prior epidemiology studies of PWS have examined smaller populations, with limited research in a US population. The aim of this study was to provide a contemporary estimate of PWS prevalence and annual all-cause mortality in the US using a large administrative medical claims dataset. Methods: PWS patients were identified between 2012-2014 via the presence of ≥2 claims with a diagnosis code for PWS on medical claims provided by IQVIA™ Health Plan Claims Data and CMS Medicare fee-for-service claims. Patients were grouped into age bands including: 0-2, 3-8, 9-17, 18-26, 27-49, and ≥50. PWS prevalence and mortality rates were calculated for 2014, then 2018 US census data was used to project rates for the total US population. The presence of select diagnoses and procedures suggestive of a life-threatening event (e.g., mechanical ventilation) with a patient’s prompt disenrollment defined as death in the IQVIA data; vital status is indicated in Medicare data. Results: Overall US diagnosed PWS prevalence was 2.7 per 100k persons (or 1 per 37,037), a prevalence of 8,870 patients in the US in 2018. Diagnosed PWS prevalence 3.9, 5.2, 4.5, 4.2, 2.5, and 1.1 per 100k persons respectively for age bands 0-2, 3-8, 9-17, 18-26, 27-49, and ≥50. The median age of PWS patients was 21 years. The mortality rate was highest among diagnosed PWS patients aged 0-2 years and lowest among those aged 9-17 years and the overall mortality rate was 2.7%. For all respective age bands 0-2, 3-8, 9-17, 18-26, 27-49, and ≥50, the all-cause mortality rate was 5.4%, 3.0%, 1.4%, 2.1%, 2.4%, and 4.5%. The observed median age of death was 23 years (IQR 6-36) Conclusions: The diagnosed PWS prevalence of 1 per 37,037 persons estimated for the 2018 US population is comparable to the other reported US prevalence estimate. As the current study describes diagnosed patients, it likely represents a lower bound of true PWS prevalence. Annual PWS mortality is ≥3 times higher than the overall US population (2.7% vs 0.8%). This rate appears unchanged from mortality estimates reported for PWS populations in the last several decades despite significant advances in genetic testing and the availability of growth hormone therapies in the US. Aggressive management of serious comorbid conditions, especially in younger PWS patients, should be a clinical priority.

Prader-Willi syndrome (PWS) is a rare, complex multi-system genetic disorder characterized by hyperphagia and abnormal food-related behaviors that contribute to severe morbidity and early mortality and to a significant burden on patients and caregivers. The hyperphagia seen in people with PWS can result in significant obesity. This study assessed rates of comorbidities associated with obesity, including type II diabetes (T2D), cardiovascular disease (CVD), and sleep apnea (SA) in a large US PWS vs. a non-PWS cohort. Methods: T2D, CVD, and SA conditions for privately insured PWS and non-PWS patients aged Results: 5,060 PWS and 31,093 non-PWS patient years representing 1,461 and 9,656 unique patients were eligible for analysis. T2D was detected in 8% of PWS patients age 9–17 (vs a NZF in non-PWS), 19% (vs 1%) in ages 18–26, and 27% in ages 27–34, 35–49, and 50–64 (vs 2, 5, and 13%, respectively). Comorbid CVD was detected in 25% of PWS patients age 0–2 (vs 1% in non-PWS), 11% (vs 1%) in ages 3–8, 15% (vs 1%) in ages 9–17, 29% (vs 4%) in ages 18–26, 44% (vs 11%) in ages 27–34, 60% (vs 27%) in ages 35–49, and 78% (vs 53%) in ages 50–64. Sleep apnea was detected in a NZF of non-PWS patients aged 0–2 and in all age groups 3–8, 9–17, and 18–26, compared to 37%, 22%, 17%, and 18% of PWS patients, respectively. Sleep apnea prevalence in PWS patients was 18% (vs 1% in non-PWS) in ages 27–34, 15% (vs 3%) in ages 35–49, and 16% (vs 4%) in ages 50–64. The largest disparities between PWS and non-PWS T2D prevalence was observed in the 9–17 and 18–26 age groups. Manifestations of CVD in PWS patients ages 0–2 was characterized by high rates of congenital atrial septal and patient ductus arteriosus defects, and in adolescent and adult PWS patients featured markedly higher rates of hypertension and hyperlipidemia than non-PWS cohorts. The proportion of PWS patients with SA that also received continuous positive airway pressure or oxygen monitoring ranged from 38% to 71%. Conclusions: Across all age groups, compared to non-PWS subjects, individuals with PWS experience markedly higher rates of CVD, T2D, and SA. The increased rate of CVD in the earliest age groups is consistent with previously observed increases in congenital heart defects with PWS. The frequency and early age of onset of hypertension, hyperlipidemia, T2D and SA emphasize the need for even more aggressive management of underlying drivers such as hyperphagia and the resulting obesity and metabolic dysfunction.

Although incidence and survival are frequent topics within the solid organ transplantation (SOT) literature, the size of the surviving SOT population is not well known. Existing studies of gout in patients with SOT have focused on the incident SOT population. This analysis was performed to characterize the prevalent SOT population and the prevalence of gout within it.This study includes the 2017 United States (US) population size of recipients of kidney, heart, liver, and lung transplants that was estimated by combining primary transplant recipient cohort sizes (1988-2017) with previously published survival rates for each annual cohort's time since transplantation (0-29 years). Gout among prevalent patients with SOT was assessed using Medicare and commercial claims.A total of 637,231 US patients received a primary kidney (393,953), liver (142,186), heart (66,637), or lung (34,455) transplant between 1988 and 2017. An estimated 356,000 (55.8%) recipients were alive in 2017 (233,000 kidney; 78,700 liver; 29,300 heart; 14,700 lung). Gout was identified in 11% of prevalent patients with SOT in 2016. Higher rates of gout were seen in recipients of kidney (13.1%) and heart (12.7%) compared to recipients of liver (6.7%) and lung (5.6%) (P .0001 in both datasets). Active diagnosed gout prevalence in the US population without a SOT history was 1.1% in 2016.Hundreds of thousands of US patients are living with a transplanted organ today and these numbers are likely to increase. In patients with SOT, gout is a frequent comorbidity of which physicians should be aware. This study suggests a markedly higher rate of gout among transplant recipients compared to the general US population.

Purpose This retrospective analysis of medical chart data was performed to compare severity and treatment of gout in patients with or without a history of kidney transplantation (KT). Methods Via an online survey, a panel of board-certified US nephrologists (N = 104) provided the following deidentified chart data for their 3 most recent patients with gout: age, sex, serum uric acid, numbers of swollen or tender joints, visible tophi, gout flare events (prior 12 months), gout drug treatment history, and KT history. The presence of “severe, uncontrolled gout” was defined as: serum uric acid ≥ 7.0 mg/dL, ≥1 tophi and ≥2 flares in the last 12 months, and history of xanthine oxidase inhibitor treatment. Results Twenty-five out of 312 (8.0%) gout patients had a history of KT. Univariate analysis found that patients with gout and history of kidney transplants had: greater prevalence of severe uncontrolled gout (27% vs 8%, P = .007) and tophi (36% vs 17%, P = .030), and higher rates of failure or physician perceived contraindication to allopurinol (44% vs 23%, P = .028). Conclusion This study provides preliminary evidence that gout in patients with history of KT is more severe and poses greater challenges to pharmacologic management. Although gout has been linked to worse outcomes among kidney recipients in the literature, there are presently no publications on gout severity among patients with KT in comparison to other patients with gout. Further investigation of disease severity and appropriate, effective treatment options in recipients of kidney transplant with a diagnosis of gout, especially prior to the transplant, is warranted.

BACKGROUND Kidney transplantation is associated with increased prevalence of gout. However, evidence of the effect of gout on long-term kidney transplantation outcomes is mixed. This study examined mortality risk among patients with a history of kidney transplantation with vs. without gout. MATERIAL AND METHODS A retrospective study was conducted using Medicare Fee-for-Service administrative claims of patients with a history of kidney transplantation. Cox proportional hazards models determined the effect of gout on all-cause mortality, controlling for confounders, including comorbid mortality risk, via the Charlson Comorbidity Index. Because the relationships between gout and components of the Charlson Comorbidity Index are also debated, 3 different model assumptions were used: 1) gout shares a common cause with these comorbidities, 2) gout is upstream of these comorbidities, 3) the effect of gout on mortality is modified by these comorbidities. RESULTS Gout increased the risk of all-cause mortality in the unadjusted model (hazard ratio: 1.44, 95% CI 1.27-1.63) and after adjustment for demographics and transplant vintage (hazard ratio: 1.16, 95% CI 1.02-1.32). Gout was not a significant risk after adjustment for baseline Charlson Comorbidity Index (hazard ratio: 1.03, 95% CI 0.90-1.17). Gout was associated with greater mortality among patients without baseline comorbidities (Charlson Comorbidity Index=0; hazard ratio: 3.48, 95% CI 1.27-9.57) in the stratified model. CONCLUSIONS Among patients with a history of kidney transplantation, gout did not have an independent effect on all-cause mortality. However, gout was a predictor of mortality among patients with no comorbidities, suggesting that gout is an early warning sign of poor health in kidney transplantation patients.

BACKGROUND Bacterially contaminated platelets (PLTs) remain a serious risk. The Food and Drug Administration has issued draft guidance recommending hospitals implement secondary testing or transfuse PLTs that have been treated with pathogen reduction technology (PRT). The cost implications of these approaches are not well understood. STUDY DESIGN AND METHODS We modeled incurred costs when hospitals acquire, process, and transfuse PLTs that are PRT treated with INTERCEPT (Cerus Corp.) or secondary tested with the PLT PGD Test (Verax Biomedical). RESULTS Hospitals will spend $221.27 (30.0%) more per PRT-treated apheresis PLT unit administered compared to a Zika-tested apheresis PLT unit that is irradiated and PGD tested in hospital. This difference is reflected in PRT PLT units having: 1) a higher hospital purchase price ($100.00 additional charge compared to an untreated PLT); 2) lower therapeutic effectiveness than untreated PLTs among hematologic-oncologic patients, which contributes to additional transfusions ($96.05); or 3) fewer PLT storage days, which contributes to higher outdating cost from expired PLTs ($67.87). Only a small portion of the incremental costs for PRT-treated PLTs are offset by costs that may be avoided, including primary bacterial culture, secondary bacterial testing ($26.65), hospital irradiation ($8.50), Zika testing ($4.47), and other costs ($3.03). CONCLUSION The significantly higher cost of PRT-treated PLTs over PGD-tested PLTs should interest stakeholders. For hospitals that outdate PLTs, savings associated with expiration extension to 7 days by adding PGD testing will likely be substantially greater than the cost of implementing PGD-testing. Our findings might usefully inform a hospital's decision to select a particular blood safety approach.

Background & Aims Rectal bleeding is associated with colorectal cancer. We characterized the evaluation of patients aged 40 years and older with rectal bleeding and identified characteristics associated with inadequate evaluation. Methods We conducted a retrospective review of records of outpatient visits that contained reports of rectal bleeding for patients aged 40 years and older (N = 480). We studied whether patient characteristics affected whether or not they received a colonoscopy examination within 90 days of presentation with rectal bleeding. Patient characteristics included demographics; family history of colon cancer and polyps; and histories of screening colonoscopies, physical examinations, referrals to specialists at the index visit, and communication of laboratory results. Data were collected from medical records, and patient income levels were estimated based on Zip codes. Results Nearly half of the patients presenting with rectal bleeding received colonoscopies (48.1%); 81.7% received the procedure within 90 days. A history of a colonoscopy examination was more likely to be reported in white patients compared with Hispanic or Asian patients ( P = .012 and P = .006, respectively), and in high-income compared with low-income patients ( P = .022). A family history was more likely to be documented among patients with private insurance than those with Medicaid or Medicare ( P = .004). A rectal examination was performed more often for patients who were white or Asian, male, and with high or middle incomes, compared with those who were black, Hispanic, female, or with low incomes ( P = .027). White patients were more likely to have their laboratory results communicated to them than black patients ( P = .001). Conclusions Sex, race, ethnicity, patient income, and insurance status were associated with disparities in evaluation of rectal bleeding. There is a need to standardize the evaluation of patients with rectal bleeding.

OBJECTIVE: As home medication use increases, medications previously managed by nurses are now managed by patients and their families. Our objective was to describe the types of errors occurring in the home medication management of children with cancer. METHODS: In a prospective observational study at 3 pediatric oncology clinics in the northeastern and southeastern United States, patients undergoing chemotherapy and their parents were recruited from November 2007 through April 2011. We reviewed medical records and checked prescription doses. A trained nurse visited the home, reviewed medication bottles, and observed administration. Two physicians independently made judgments regarding whether an error occurred and its severity. Overall rates of errors were weighted to account for clustering within sites. RESULTS: We reviewed 963 medications and observed 242 medication administrations in the homes of 92 patients. We found 72 medication errors. Four errors led to significant patient injury. An additional 40 errors had potential for injury: 2 were life-threatening, 13 were serious, and 25 were significant. Error rates varied between study sites (40–121 errors per 100 patients); the weighted overall rate was 70.2 errors per 100 patients (95% confidence interval [CI]: 58.9–81.6). The weighted rate of errors with injury was 3.6 (95% CI: 1.7–5.5) per 100 patients and with potential to injure the patient was 36.3 (95% CI: 29.3–43.3) per 100 patients. Nonchemotherapy medications were more often involved in an error than chemotherapy. CONCLUSIONS: Medication errors were common in this multisite study of outpatient pediatric cancer care. Rates of preventable medication-related injuries in this outpatient population were comparable or higher than those found in studies of hospitalized patients.

Purpose: Observational studies describe high rates of errors in home oral chemotherapy use in children. In hospitals, proactive risk assessment methods help front-line health care workers develop error prevention strategies. Our objective was to engage parents of children with cancer in a multisite study using proactive risk assessment methods to identify how errors occur at home and propose risk reduction strategies. Methods: We recruited parents from three outpatient pediatric oncology clinics in the northeast and southeast United States to participateinfailuremodeandeffectsanalyses(FMEA).AnFMEA is a systematic team-based proactive risk assessment approach in understanding ways a process can fail and develop prevention strategies. Steps included diagram the process, brainstorm and prioritize failure modes (places where things go wrong), and propose risk reduction strategies. We focused on home oral chemotherapy administration after a change in dose because prior studies identified this area as high risk. Results: Parent teams consisted of four parents at two of the sites and 10 at the third. Parents developed a 13-step process map, with two to 19 failure modes per step. The highest priority failure modes included miscommunication when receiving instructions from the clinician (caused by conflicting instructions or parentlapses)andunsafechemotherapyhandlingathome.Recommended risk assessment strategies included novel uses of technology to improve parent access to information, clinicians, and other parents while at home. Conclusion: Parents of pediatric oncology patients readily participated in a proactive risk assessment method, identifying processes that pose a risk for medication errors involving home oral chemotherapy.

Summary Esophageal symptoms are common during radiation and chemotherapy. It is unclear how often these symptoms persist after therapy. We retrospectively reviewed medical records of 320 adults treated for nonmetastatic breast cancer (84), lung cancer (109), or Hodgkin and non-Hodgkin lymphoma (127) who were disease-free at 10–14 months after therapy. Treatment included chemotherapy with or without nonmediastinal radiation therapy (150 patients), chemotherapy plus sequential mediastinal radiation therapy (MRT) (48 patients), chemotherapy plus concurrent MRT (61 patients), or non-MRT only (61 patients). Proton pump inhibitor use was documented. All treatment groups had similar prevalence of the esophageal symptom of heartburn before therapy. Rates were higher during treatment in those who received MRT with or without chemotherapy, but declined by 10–14 months after treatment. However, low baseline rates of dysphagia (4%) and odynophagia (2%) increased significantly after combined chemotherapy and MRT to 72% for dysphagia and 62% for odynophagia (P

Objective To analyze the print news media's coverage of sentinel events involving cancer patients. Methods Using LexisNexis, we identified English-language newspaper articles covering medical errors in cancer care between January 1, 2000, and December 31, 2010. Articles were coded for 3 major themes using a standardized abstraction instrument: narrative statements and point of view most prominently represented, attribution of blame, and orientation toward patient safety. We also abstracted country where the newspaper was published, type of error event, and extent of patient harm. Results We analyzed 64 articles from 37 print newspaper syndications that circulated in 6 countries/regions. Reports of medical errors rarely were framed from the point of view of a safety expert or the responsible clinician (13% and 3%, respectively) compared with the patient and legal points of view (both 30%). Articles held individual clinicians (41%) and hospital systems (28%) responsible for most errors. Four in 10 articles failed to present medical errors as "systems" problems. Article perspective varied considerably by country, with 53% of articles from the UK and 63% from Australia and New Zealand judged as negatively slanted compared with 14% in the United States and Canada. Conclusions In reports of medical errors involving cancer patients, the news media regularly blame individual clinicians for mistakes and fail to present a systems-based understanding of these events.

Because cancer chemotherapy is a high-risk intervention, ASCO and the Oncology Nursing Society (ONS) established in 2009 consensus- and evidence-based national standards for the safe administration of chemotherapy. We sought to assess the implementation status of the ASCO/ONS chemotherapy administration safety standards.A written survey of chemotherapy practices was sent to National Cancer Institute-designated cancer centers. Implementation status of each of 31 chemotherapy administration safety standards was self-reported.Forty-four (80%) of 55 eligible centers responded. Although the majority of centers have fully implemented at least half of the standards, only four centers reported full implementation of all 31. Implementation varied by standard, with the poorest implementation of standards that addressed documentation of chemotherapy planning, agreed-on intervals for laboratory testing, and patient education and consent before initiation of oral or infusional chemotherapy.Given wide variation in the implementation of ASCO/ONS chemotherapy administration safety standards at US cancer centers, there are significant opportunities for improvement.

G A A b st ra ct s chose acid, 8 sweet, 3 bitter. Subjective improvement in swallowing was reported by 10 patients, 6/8 on sweet thickener, 2/9 on acid, and 2/3 on bitter thickener. Objective improvement of the SDQ score was reported by 13/20, patients 5/9 on acid thickener, 7/8 on sweet, and 1/3 on bitter. Score for cough during swallowing of liquid was rated 2.2±1.0 on usual diet and 1.8±1.0 (p,0.03) after 6 weeks on preferred taste thickener. There was not significant body weight variation during the study period: 20% increased .1 Kg, 65% remained stable ,and 15 decreased .1 kg. Conclusions. Taste can affect swallowing function in ALS patients, being sweet and acid the most preferred and effective flavors. Flavoring liquid thickener with individualized selected taste can improve the swallowing act in ALS patients. 1) Logemann JA et al. J Speech Hear Res 1995;38:556-63 2) Cohen JT, Manor Y. The laryngoscope 2011

Background: Rectal bleeding is an alarm symptom associated with a higher rate of detecting colorectal cancer when a complete visualization of the colon is performed. Aims: 1.To determine if patients age 40 or older are receiving an adequate workup for rectal bleeding 2. To identify patient characteristics associated with an inadequate evaluation of rectal bleeding. Methods: Nurses reviewed 488 patients' (≥40 years) medical records that presented with rectal bleeding (ICD-9 diagnosis codes) from primary care visits between 2006 and 2008. Data for patient demographics, comorbidities, symptoms, physical exams, referrals and tests were entered into an abstraction tool from ten different health care centers: three academic hospitals, and seven community-based centers of which four were urban and three suburban. Race, ethnicity, income according to zip code of patient's residence, language, and need for interpreter services were recorded. Patient income was determined by zip code and divided into low (0-49th percentile), medium (50-74th), and high (>75th). MD reviewers entered judgments regarding quality of care and reasons for delays in evaluation. Data were analyzed using the Chi-square statistic. Results: Patients presenting to an academic medical center were significantly more likely (p